US20140142968A1 - Online, interactive evaluation of research performance - Google Patents

Abstract

Medical and other research organizations, sites within those organizations, and physicians practicing at those sites register in an online database. The company providing the database posts a description of a clinical trial opportunity or other research opportunity. The company can search and match for physicians with research opportunities, or the physicians can browse the list of opportunities. Once it is determined who will perform the research and awarded a contract, performance data are collected at 30-day intervals over the life of the trial for computation of benchmarks. The benchmarks from one physician are compared anonymously to those from other physicians participating in the same opportunity.

Description

REFERENCE TO RELATED APPLICATION
• The present application is a continuation of U.S. patent application Ser. No. 10/118,369, filed Apr. 9, 2002, whose disclosure is hereby incorporated by reference in its entirety into the present disclosure.
FIELD OF THE INVENTION
• The present invention is directed to a system and method for evaluation of the performance and progress of research trials and more specifically to such a system and method, which provide benchmark metrics in real time.
DESCRIPTION OF RELATED ART
• In clinical trials for pharmaceuticals and the like, data must be taken over an extended period. For example, at intervals of time, typically 30 days, data must be taken on the number of patients who are participating in the trial, the number who have dropped out, the queries per patient, and the like.
• However, the data are typically collected and tabulated by pharmaceutical companies to manage their project timelines. Such information is rarely shared with the physicians and health-care professionals conducting the research studies for purposes of understanding how they are performing, how other research sites are doing and/or learning from other clinicians participating in the study about how to improve their study management and performance. Currently no electronic mechanism exists that systematically, and automatically provides clinicians the ability to interact with the physicians and health-care professionals conducting the research studies for purposes of understanding how they are performing, how other research sites are doing and or learning from other clinicians participating in the study about how to improve their study management and performance. Currently no electronic mechanism exists that systematically and automatically provides clinicians and/or pharmaceutical sponsors with the ability to obtain interactive, real-time benchmarks and with those benchmarks better assess physician capabilities for matching physicians and research sites and with those data better assess physician capabilities for matching physicians and research sites for future clinical trials.
• One Internet-based technique for matching experts in the biological sciences with those needing their services is disclosed in WO 01/29708, published Apr. 26, 2001. That technique provides for matching based on qualifications and times of availability as well as payment. However, once the experts and their customers are matched, there is no evaluation of the work, which the former do for the latter.
SUMMARY AND OBJECTS OF THE INVENTION
• It will be readily apparent from the above that a need exists in the art for an online, interactive evaluation of research performance. It is therefore a primary object of the invention to collect data concerning the progress of research and to provide an evaluation based on the collected data.
• It is another object of the invention to provide an interactive, automated, online technique for doing so.
• It is a further object of the invention to provide such an evaluation based on data collected at various time intervals.
• It is a still further object of the invention to allow comparative evaluations among various trials.
• It is a still further object of the invention to allow comparative evaluations without divulging the identity of one trial to researchers participating in another.
• To achieve the above and other objects, the present invention is directed to an online, automated technique for collecting data not only for clinical trials but for other types of medical research including: marketing research, outcomes studies, disease management, etc. This type of medical research information would be information used to support the post approval product launches, marketing, product positioning, business development opportunities including licensing from clinical trials at intervals of e.g., 30 days and for performing automated, online evaluations based on the data. The evaluations can be presented in textual or graphical formats. A common server can be used to collect data from multiple trials, with the appropriate protection of the data from each trial for privacy purposes. The comparisons, e.g., for cost per patient, can be presented anonymously; for example, the figures for the highest and lowest costs per patient can be given without identifying the sources for those figures.
• Users register for the service as organizations. The system will then ask the user to register all sites and physicians that fall under the umbrella of the organization. If a physician is a solo practitioner, the physician still must complete all three profiles, although some information may be duplicated, since each profile focuses on collecting differing information. During the registration process, each user provides information to be entered into a database. For a physician, the information concerns the physician's own practice and the site, if any, at which the physician is an administrator. For a site, the information concerns such things as the facilities at the site and the physicians practicing at the site. For an organization, the information concerns such things as the type of organization and the sites and physicians within the organization.
• A listing of a clinical trial opportunity (blinded synopsis) or other research opportunity (blinded synopsis) with an accompanying protocol synopsis specific questionnaire (SQQ) is posted on the website. The listing is categorized to allow browsing by prospective researchers who are members. In addition, the service can search the database to find suitable physicians, sites or organizations who preliminarily match the criteria the sponsor has provided to the service and then select which ones are to be contacted about the clinical trial opportunity. That occurs by cross-referencing project requirements with general information about the sites, physicians and organizations. Contacting members about opportunities occurs via e-mail or facsimile to invite them to consider the opportunity. Following the researchers' completion of any new data not currently in the database and contained in the SQQ, the research electronically submits the completed SQQ via email to the service. The service summarizes all the information across all completed SQQ's for the specific research opportunity and forwards qualified and matched researchers to the sponsor. The sponsor then selects which research provided by the service they will select for the clinical trial.
• Once a researcher is selected for the study, information about the study is entered into the database, e.g., at the beginning and end of the study and at 30-day intervals or less therebetween. The information concerns such things as the number of patients who have signed up and the number who have dropped out. Thus, benchmarks can be computed over time.
• Study (clinical trial/protocol) specific benchmarks from one researcher, site and or organization can be anonymously compared with those from other researchers, sites and/or organizations. In one example of a comparison, four values of a benchmark are given: the highest and lowest values from the researcher, site and organization participating in the study any study, the median from all researchers, sites and/or organizations, and the actual value from the researcher, site and/or organization with which the person viewing the results is linked in which the person viewing the results is participating. The identities of the other researchers, sites and/or organizations from which the information is provided are not given, thus preserving confidentiality. The user can thus see how their researcher, site and or organization performance results for the study compares with other researcher, site and/or organization performance results for the study and can use that information, e.g., to see where efficiency can be improved, budgets should be reallocated, patients that qualify for the study can be found, training is required or to make the case for an increase in the research budget.
BRIEF DESCRIPTION OF THE DRAWINGS
• A preferred embodiment of the present invention will be set forth in detail with reference to the drawings, in which:
• FIG. 1 shows a hardware architecture on which the preferred embodiment can be implemented;
• FIGS. 2,2A-2I,3,3A-3D,4 and4A-4C show flow charts and screen shots of the registration and data inputting process for new users;
• FIGS. 5A and 5B show a physician registration page;
• FIG. 6 shows a search page;
• FIG. 7 shows a search result page;
• FIG. 8 shows a flow chart of the processes involved in posting a CTO or ORO description;
• FIGS. 8A-8E show screen shots of the processes ofFIG. 8;
• FIG. 9 shows a merge page;
• FIGS. 10 and 11 show pages used in collecting progress data;
• FIGS. 12 and 13 show pages used in displaying benchmark data; and
• FIG. 14 shows a flow chart of operation of an enhancement to the service which allows physicians to obtain information on fees.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
• A preferred embodiment of the present invention will now be set forth in detail with reference to the drawings, in which like reference numerals refer to like elements or process steps throughout.
• FIG. 1 shows an example of a hardware architecture on which the preferred embodiment can be implemented. The design of the hardware architecture has been selected to follow the industry-standard N-tier architecture, separating site navigation and design from stored procedures and data. In that way, one part of the site can be redesigned without breaking another part of the site. For instance, the HTML which provides the user interface can be changed without affecting the stored procedures and tables of the database.
• FIG. 1 shows such ahardware architecture100.Client devices102, which can be microcomputers or any other devices capable of communicating over the Internet, connect via anysuitable connections104, such as dial-up or cable modem connections, to theInternet106, and thence via a full-time Internet connection108 to aWeb server110. The client devices are used by physicians, research sponsors, research sites such as hospitals, and others participating in the operations of the preferred embodiment. TheWeb server110 provides business services, such as site navigation and design, and is connected via a full-timededicated connection112 to a database server114 storing the stored procedures and database tables. Thus, theclient devices102 access the stored procedures and database tables in the database server114 only through theWeb server110. It is preferable to implement theWeb server110 and the database server114 on separate, dedicated machines to facilitate backups and restarts with a minimum of disruption. TheWeb server110 implements interactive HTML pages through known technologies, such as CGI or ASP.
• The database stored in the database server114 is populated when physicians and organizations register and provide the information required for registration. As is known in the art, theWeb server110 provides persons accessing it fromclient devices102 with several options, including physician registration and organization registration.
• A user registers as an organization; physician registration and site registration are part of organizational registration. As noted above, a solo practitioner still registers as an organization. The organizational registration has two parts, the first part resulting in temporary status and the second part resulting in active status.
• FIG. 2 shows an overview of organization registration. Atstep202, the user is prompted for the name and address of the organization and for the type of organization (see the Web page ofFIG. 2A). The latter is preferably selected through check boxes, so that multiple choices may be selected, although it may be selected through a drop-down menu or radio buttons if only one choice is allowed. Atstep204, once that information is received, a temporary user identification and password are generated and provided to the user (or the user can select them; seeFIG. 2B). The user is then allowed to view more detailed descriptions of the research opportunities; however, if any particular opportunity is selected, the user must proceed to the second part of the registration.
• That second part begins atstep206, in which the user is prompted to complete an organizational profile (seeFIG. 2C). When the User is completing the site location section of the organization profile, the first page of the organization profile asks “how many site locations” atstep208, and this automatically generates, atstep210, a table (seeFIG. 2D) on page two of the organization profile with the necessary number of rows for all site locations. The User must complete this table in order to advance to page three of the organization profile; that will generate the correct number of site profiles. Atstep212, the user completes a physician profile (seeFIG. 2E) for each physician within the organization, until it is determined at step214 (seeFIG. 2F) that profiles have been completed for all physicians within the organization; step214 can be performed likestep210. Identifications and passwords are generated for the organization as a whole, for each site, and for each physician atsteps216,218 and220, respectively (seeFIG. 2G). Atstep222, it is indicated in the database that the organization's status is that of an active member (seeFIG. 2H). Atstep224, the identifications and passwords are sent to the organization. Atstep226, a responsible person at the organization has the option to change the identification and password for the organization (seeFIG. 2I). The organization representative has the ability to change any data about the organization, sites or physicians and has complete access to all three profiles. The representative cannot add further sites or physicians or edit the name of a physician.
• FIG. 3 shows an overview of the physician registration process ofstep212. At step302 (seeFIG. 3A), the Web server asks whether the physician is an administrator at the site at which the physician works. If it is determined atstep304 that the physician has answered in the affirmative, the physician is prompted at step306 (seeFIG. 3B) for information about the site, in a manner which will be described in detail below. If not, the physician is prompted atstep308 for the name of an administrator at that site. Either way, the physician's information is taken in a physician information form at step310 (seeFIG. 3C). A user identification (ID) and password (PW) are generated for the physician at step312 (seeFIG. 3D).
• FIG. 4 shows an overview of the site registration ofstep210. The number of sites input by the user is received at step402 (seeFIG. 4A). As noted above, a table of site locations, having a sufficient number of rows, is generated at step404 (seeFIG. 4B). The user completes the table, including information for each site, at step406 (seeFIG. 4C).
• The data entry forms will now be described. In general, a data entry form can be implemented in HTML as one page or several; if it is implemented in several pages, each page ends with “Next Page” (or if the last page of the form “Submit”), “Discard Changes and Exit” or “Save Changes and Exit” options. Also, the same forms can be used to add information about new users and to update information for existing users.
• FIG. 5A shows the first page of the physician's form. Thefirst page502 includes anarea504 for contact information, an area506 for medical licensing and DEA information, and an area508 in which the physician can identify specialties through drop-down menus. Other information, such as professional affiliations with one or more medical schools and hospitals, can be solicited here. There are also “Next Page” (or if the last page of the form “Submit”), “Main Page” and “Save Changes and Exit”buttons510,512 and513, as mentioned above.
• FIG. 5B shows a subsequent page514 of the physician's form. As shown inFIG. 5B, the physician is asked about experience as a principal investigator in a clinical trial. Detailed experience on each clinical trial can be solicited in further pages, as well as information on any FDA or sponsor audit that the physician or the site has undergone, any administrative roles that the physician plays at the site, any articles or presentations in which the physician is named as an author, and any organizations and associations in which the physician is actively involved.
• The pages requesting organization and site information are similar. In addition, the organization pages request the type of organization, while the site pages request what facilities the site has, among other things. Pages can also be provided to transfer a physician from one site or organization to another or to transfer a site from one organization to another. This function is accessible solely to employees of the service, not registered users.
• The administrator of the database server114 can accept the information as given or can take various steps to verify it. For example, the administrator can verify that a given facsimile number or e-mail address words, check a given medical license number, or interview either the person submitting the information or those persons named as references.
• Once all of the data concerning participating physicians, organizations, and sites have been entered into the database, the database can be searched.FIG. 6 shows a search page for searching for physicians. Thesearch page600 uses text boxes and drop-down menus, although other suitable interface elements can be used as needed. In any text box, wildcard searching can be allowed.
• Physicians can be searched by name, site, organization, or any combination of the three by use of the text boxes602,604,606. The drop-down menu608 allows the search to be conducted for physicians who are members, non-members, or either. The person conducting the search can select a state through a drop-down menu610 or a region through a drop-down menu612. A specialty can be selected through a drop-down menu614. Key words can be entered in atext box616. Thepage600 can be designed to include any other search criteria, such as those relating to clinical trial experience. Once all of the search criteria are entered, the user clicks on the “Find Physicians” button618.
• Clicking on the “Find Physicians” button618 causes the database server114 to search for physician records matching the search criteria. The database server114 passes the search results to theWeb server110 which formats them as shown inFIG. 7. The search resultspage700 shows the search results in the form of a table702. At the far left is aselect column704, which allows the user to select individual physicians for further consideration or to select all physicians through a “Select all”check box706. Thename column708 lists the physicians by name, with links to their profiles in the database. Thespecialty column710 gives each physician's specialty. Theorganization column712 and thesite column714 identify the organization and site, respectively, with which each physician is associated and include links to those organizations' and sites' profiles. Atelephone number column716 and afacsimile number column717 give that information for each physician. Themembership status column718 identifies each physician as a member or non-member. TheCTO column720 and theORO column722 list CTO's and ORO's, respectively, with which the physician is or has been involved. Columns can be sorted by clicking on the name of the column. Anindicator726 identifies the number of physicians who have matched the query. Themerge buttons728 and730 allow the user to merge the records for the selected physicians with a CTO or ORO in a manner to be explained below.
• An employee of the service can enter a CTO or ORO as shown inFIG. 8. At step802, the following are selected through drop-down menus or other suitable interface elements (seeFIG. 8A): the specialty concerned (e.g., urology), the estimated number of patients, and the duration. Atstep804, the following are input as free-form text (seeFIG. 8B): a descriptive title of the study, one or more inclusion criteria for patients (e.g., male patient aged 40-85 years), one or more exclusion criteria for patients (e.g., no previous prostatic surgery within two weeks of base line), and a per-patient budget (this can be indicated as “to be negotiated”). The criteria can also be selected through drop-down menus, in which case there will be an option to add criteria not appearing in the menus. The criteria can also be assigned a sorting order. Through a Design SQQ/PQQ Interface, the relevant SQQ or PQQ is designed and posted on the web at step806 (seeFIG. 8C). A number is manually assigned at step808 (seeFIG. 8D). The opportunity can be made viewable to network members only by an employee of the service at step810 (seeFIG. 8E). The CTO or ORO can be made viewable to persons viewing the organization's or site's profile or in a list sorted by specialty; preferably, both are done.
• Once the CTO or ORO is entered, the search results fromFIG. 7 can be merged into the CTO or ORO. Once thebutton728 or730 is clicked, themerge page902 or904 in the merge area900 ofFIG. 9 appears. The user can select the Merge CTO orMerge ORO902 or904 and click the “Merge” button906 or may cancel by closing the window. If the “Merge” button906 is clicked, all of the selected search results fromFIG. 7 are linked to the description of the CTO or ORO in the database. Checking for duplicate records is done automatically.
• The physicians, organizations, or sites merged into the listing can be invited to consider the CTO or ORO. Since anyone found in the search results will have provided some contact information, the invitation can be made by e-mail, facsimile, or any other suitable channel.
• Thus, the service (or, in an alternative embodiment, a sponsor of a CTO or ORO) can initiate contact with a physician, organization or site which may be suited to conduct that CTO or ORO, as described above with reference toFIG. 9. Either way, the questionnaire is completed and returned to the sponsor. The sponsor considers the questionnaire and can send a person to interview the physician or otherwise visit the organization or site at which the trial or other research would take place. A Web page can be provided to indicate the reasons why any particular physician, organization or site was accepted or declined. That Web page is accessible only by employees of the service or network members who have registered to use the system.
• Once a physician, organization or site is selected to conduct the trial, data are collected for benchmarking. General (industry) benchmarks include the following: revenue per primary investigator per year, patients enrolled per number of coordinator FTE's, average revenue per patient, distribution of revenue by type, average enrollment as a percentage of goal, split of patient recruitment between in-house and advertised, average number of protocols per year, average number of years in clinical research, percentage of studies through third party, percentage of studies directly from CRO or sponsor, number of sponsors with which a particular physician, site or organization has worked, and number of CRO's with which a particular physician, site or organization has worked. Benchmarks specific to a particular study include the following: time to first patient enrolled, total patients enrolled after the first thirty days, actual enrollment as a percentage of the enrollment goal, per-patient budget, number of queries per patient, enrollment as a percentage of total patients screened, and elapsed time from notification of award of study to initiation visit. Data entered into the Web Form (Site Status Summary, or SSS) are used to compute the benchmarks specific to a particular study. Those data are collected on a per-protocol basis, are specific to that protocol and are not stored for future protocols. On the other hand, information collected in the profiles can be used to update the SQQ/PQQ.
• Examples of Web pages for taking data associated with a particular study are shown inFIGS. 10 and 11 as1000 and1100, respectively. Thepage1100 is only partially shown, since the data are taken not simply at the end of 30 days, but rather at the end of every 30-day interval until the end of the study; for instance, thepage1100 may ask for the number of patients screened after 720 days, etc. At the end of the study, data may be collected, such as the date of the study close-out visit and the number of queries generated.
• The benchmarks are calculated automatically by the system. The more data inputted, the more an organization can access. They do not have to wait until the study is over until they can view benchmarks, but as soon as the relevant data are input the benchmark is viewable. Once all of the data are input and the study is concluded, or once the data currently available are input if benchmarking during the study is required, benchmarking can be performed using straightforward calculations on the data. Two examples of data outputs are shown; those skilled in the art will recognize that many other types of data outputs can be provided as needed.
• FIG. 12 shows abar chart1200 in which the total budget per patient is broken down into overhead, procedure and lab fees, the study coordinator, and the investigator fees.FIG. 13 shows abar chart1300 showing a particular benchmark by its value in the user's study compared to its high, low, and average values from among all organizations participating in the same opportunity monitored by the database server114. The identities of the other organizations are not identified. Each of the bars of thebar chart1300 can be broken up like the bar in thebar chart1200.
• The benchmarks can be displayed to the sponsor of the study, the physician, site or organization conducting the study, or both. Non-numerical information, such as the identities of the physicians involved in the study and information about them, can also be reported.
• An enhancement to the service provides a customizable search page for the “study budget project” where physicians can search for a price range for their service. The search is intuitive enough to allow physicians to select predetermined criteria to focus their search. Physicians will also be able to download their study budget information in a standard template usable in a spreadsheet program (e.g., Microsoft Excel).
• At step1402, a study budget system is provided, which is a separate module from the service previously described. Atstep1404, the user logs in. Members will pay a yearly license fee, billed monthly. Existing users will be able to retrieve their user name and password information by entering their e-mail address.
• If the system determines atstep1406 that the user is a new user, or is an existing member using the system for the first time, the user will be required to complete an activation form atstep1408. On confirmation of the user's credit card, the user will receive a welcome message and information about their subscription via e-mail.
• Atstep1410, the user will choose from standard study questions about that user's procedure type, which sets the parameters for the query. Atstep1412, the user receives high, average, and low fees for the selected query.
• Atstep1414, a study budget template is provided in order to be populated with the user's information. The study budget template provides automatic calculations and a printable template. At step1416, on completion of the template, the information is updated to the database.
• While the disclosure set forth above is believed to provide an enabling disclosure of the present invention and a best mode for carrying out the present invention, an administrative-level user's guide will now be set forth for the sake of completeness. For ease of understanding, the user's guide is organized in tabular form.

• Question	Topic	Response
  What happens	New Site	If it is completed on-line,
  when a site	Applications	E-mail Copy automatically goes to the service.
  completes their	Completing	The Site Recruiter then logs onto
  application on-	Reference Check	www.rapidtrials.com/orge.asp
  line or hard	Information on	They select the organization name from the drop
  copy?	Rapidtrials	down list and hit EDIT
  	Activating a New	They move using ALT + N or Next Page to the last
  	Site	page of the profile
  		The last page lists the references
  		They also list whether the references were:
  		“outstanding”
  		“Average”
  		“Unfavorable”
  		Once the reference checks are done, these are
  		changed as appropriate
  		The date the contract is signed is inputted into the
  		first page, as well as some other contract
  		information.
  		Once the site is ready to be a member of the
  		network the site recruiter goes to the first page of
  		the organization profile, by going to
  		www.rapidtrials.com/orge.asp, members admin,
  		selecting the org name from the drop down and
  		hitting EDIT
  		Members admin page drop down list of
  		organizations If the organization is in black it is an
  		active member of the network, if the org is in blue
  		or any other color you can check the status by
  		going to Edit and looking at the status drop down
  		halfway down page one of the organization profile.
  		Halfway down the first page is a status drop down.
  		The status is:
  		Active
  		Terminated
  		Contact
  		Hold
  		Pending
  		Inactive
  		The organization status is changed to Active. This
  		automatically creates a second browser window
  		with the User ID and Passwords for that
  		organization.
  		You then select Export to XLS, and these can be
  		printed out from XLS and faxed to the
  		organization.
  		You then close the second browser window and
  		select ‘Save changes and Exit’
  		This organization is now an Active member of the
  		network and has full access to the member's
  		section.
  How do I put a	Posting a New	The Project manager identifies a new CTO
  new clinical	Clinical Trial	Log on to Rapidtrials.com
  trial	Opportunity on	This will take you to CTO Admin or
  opportunity on	Rapidtrials	www.rapidtrials.com/cto/asp
  Rapidtrials	Creating a PCRS	Click New
  	Tracking Number	Enter the CTO name
  		Enter the Tracking Number
  		Enter if the CTO is recruiting Yes/No (When a
  		CTO is no longer recruiting this must be changed to
  		No)
  		Enter if the CTO is to be shown on the web Yes/No
  		(When the CTO is no longer to be viewed on the
  		web must be changed to NO)
  		Enter Project Manager Name
  		Enter which of the following are applicable (to be
  		update, as information becomes available over
  		time)
  		Sponsor
  		Sponsor contact Name
  		Sponsor Contract Name
  		CRO
  		CRO contact name
  		CRO contract name
  		Then select save
  How do I create	Creating a Synopsis	Click CTO description
  a CTO Online	for a Clinical Trial	This is where you create the synopsis for the
  	(CTO)	clinical trial
  		For those choices that appear in blue, click on the
  		blue link, type in the text that is to appear under
  		that link, click save and click return
  		Select Therapeutic Area and indication from the
  		dropdown
  		Date CTO sent to sites
  		CTO Phase
  		Study design
  		Status-Proposed or awarded
  		Study Objective
  		Investigator specialty, up to three from dropdown
  		Clinical Experience, do they have to have
  		experience or can they be trial naive
  		Is a certain number of past clinical trials necessary,
  		indicate this here
  		IRB Utilization-Central or Local
  		Type of site, check all that apply
  		Is it Inpatient/Outpatient?
  		Key Inclusion Criteria
  		Key exclusion Criteria
  		Removal of patients from therapy
  		Length in enrollment in months
  		Note: This generates the correct amount of 30 day
  		increments for the benchmarking
  		Expected enrollment
  		Duration of therapy
  		Number of patient visits
  		Investigator Meeting
  		Anticipated Start Date
  		Special request/equipment
  		Budget
  		There are then 5 extra criteria, which you can label
  		and then enter text for
  		Click Save
  How do I create	Creating an SQQ	Click SQQ design
  a Site	Using the same	If there is another SQQ already created that you
  Qualification	template as a	know is identical to the one you wish to create, or
  Questionnaire	previously	very similar so that you would change just one or
  (SQQ) Online	developed SQQ	two things-
  	Creating Custom	Click Load SQQ pattern from another CTO
  	Questions	Select CTO Name and click OK
  		Say OK
  		This will create the same SQQ for your clinical trial
  		OR
  		To create a brand new SQQ
  		Click SQQ design
  		There will be a list of standard questions, these are
  		questions that if they are completed on the profiles
  		will pre fill for the Investigators
  		Select those you wish to delete
  		Note: The one that is blank is actually Board
  		Certification
  		If you wish to create specialized questions, in
  		addition to the standard questions, click Further
  		Criteria
  		Click Simple Questions
  		A Question Interface appears
  		Let's use some examples:
  		How far away is the nearest airport?
  		___in miles
  		Which of the following apply to your site? Small,
  		Medium or Large
  		Check all that your site has ECG, Sleep Lab, Study
  		Coord
  		What date is your next IRB meeting?
  		Using the Interface Label-
  		1. Question One
  		Label = How far away is your site
  		After Label = miles
  		Question Type = Text box
  		Question Data Type = Text
  		Multiple Choices =
  		2. Question Two
  		Label = Which of the following apply to your site?
  		After Label =
  		Question Type = Combo Box (only one
  		answer allowed)
  		Question Data Type = Numeric
  		Multiple Choices = Small, Medium, Large
  		3. Question Three
  		Label = Check all that your site has
  		After Label =
  		Question Type = Multiple Choices (allows
  		for more than one answer)
  		Question Data Type = Numeric Multiple Choices
  		= ECG, Sleep
  		Lab,Study Coord
  		4. Question Four
  		Label = What date is your next IRB meeting
  		After Label =
  		Question Type = Text box
  		Question Data Type = Date
  		Multiple Choices =
  		Then Click Save
  		This saves your question and it shows up under the
  		Criteria Label
  		Continue clicking Simple Questions and then
  		creating questions until you are done
  		To change any question you have already created,
  		click the blue link and make your changes and click
  		save
  		When you are done Click SQQ combination, this
  		merges the standard questions and the special
  		questions
  		Click re number, and then number the questions so
  		that they appear in the correct order.
  		To delete a question click the delete box then save
  		To make further changes to the special questions
  		click Edit further criteria and click on the blue links
  		and make the change, click save and then SQQ
  		combination
  		When you are satisfied with the order click Save
  		Then click Save Changes and Exit
  TO send		The project manager will provide with the new
  automatic		CTO a list of specialties who need to be informed
  emails to the		about this trial
  orgs to inform		From CTO admin, click search, this appears above
  them of a new		the matched site window
  CTO		This will take you to the search page
  		Select enable-Membership Status
  		The choices are member, non-member, or all
  		Select member
  		Under Investigator specialty, click enable and
  		choose the specialty from the drop down box
  		Note; The search by specialty is an AND search,
  		not an OR search. So choose only one specialty at a
  		time.
  		Click Find Physicians
  		At the bottom of the search results page, click
  		select all
  		Review the list and those that you do not wish to
  		inform of the clinical trial unselect them by clicking
  		on the checkmark on the left-hand side so that the
  		box is empty.
  		Then click merge CTO
  		Select the CTO name
  		Click Merge
  		This will dump the sites you selected into the
  		matched window on the CTO admin page
  		Repeat with each specialty until completed
  		From CTO admin
  		Click Select All next to matched window
  		Click Send SQQ and description
  		This will create an email and fax list of all the
  		matched organizations
  		To send the email click send mail all
  		One email is sent to each organization contact
  		person that you identified, the email lists all the
  		suitable investigators at that site.
  TO add a		Go to CTO admin
  doctor that has		Under CTO name drop down list, select the name
  submitted for a		and click Edit
  clinical trial		OR
  		Enter tracking number on the top bar and click
  		EDIT
  		IF
  		Doctor appears in matched window
  		Doctor does not appear in matchedwindow
  		1. Select his name by clicking on it
  		Click SSS
  		Then click EDIT under Update
  		Compete the first page:
  		Date of submission deadline
  		Date of submission
  		Date notified of submission
  		Note: This last field sends an automatic email to the
  		site when it is completed. See attached email
  		Click Save changes and Exit
  		His status will now be Submitted pendingselection
  		2. From CTO admin halfway down
  		Select Org Name
  		Select Site
  		Select Physician
  		Click ADD
  		He will go in to the top of the matched window
  		Follow above steps
  To get a list of		Go to responded window
  doctors		Click on first name in the box
  submitted for a		Click Shift
  study (not		Click on last name in the box
  including those		Click Show Info
  whose status is		Print report
  not submitted)
  To remove a		Click on his name
  doctor from a		Click remove
  trial		To view info for a doctor
  		Click his name
  		Click view info
  		Info is shown as: Name, Site, Org, Specialty, Tel #,
  		Fax #, Status, Last Change
  To update SSS		Click his name
  		Click SSS
  		Click Edit under Update
  		To view SQQ
  		Click his name
  		Click SQQ
  To add a new		Click New next to Sponsor
  Sponsor		Enter Info
  		Click Save
  		Click Return
  		Same for Sponsor Contact, Sponsor Contract, CRO,
  		CRO Contact, and CRO Contract
  	Search Page	Every criteria you enable limits your search
  		It is a wild card to search:
  		To search for Bill Jones, enable physician name
  		and enter
  		Bill
  		Jones
  		Bi
  		Ll
  		Jo
  		Nes
  		Etc
  		Click find physicians to get results
  		Results are shown as Org, Site, Physician, Phone,
  		Fax, Specialty, Status (member/non-member),
  		CTO, ORO
  		The results can be sorted by any of the column
  		headings, simply click on them
  		Clicking on the physician's name takes you to his
  		profile
  		Clicking on the site name takes you to the site
  		profile
  		Clicking on the org name takes you to the
  		organization profile
  	To transfer a doctor	If a doctor moves from one organization, or more
  		likely someone entered him in the wrong
  		organization profile
  		Search for the physicians
  		From the results page select doctor to be transferred
  		Member Admin Page
  		Organization Level
  		To create a new org, click new
  		To edit an existing org, select name from drop
  		down list and click edit
  		Click Transfer
  		Select Org and Site he is to be transferred to
  		Click Transfer
  		To view (in read only mode) an existing org, select
  		name from drop down list and click show
  		To view the sites for that org, select site name from
  		drop down and click site
  		Site Level
  		To create a new site, click new
  		To edit an existing site, select name from drop
  		down list and click edit
  		To view (in read only mode) an existing site, select
  		name from dropdown list and click show
  		To view the members for that site, select site name
  		from drop down and click members
  		To view the SSS for a site (all the trials that they
  		are linked with) click SSS
  		To delete a site, select the site name from the drop
  		down and click delete
  		Members Level
  		To create a new member, click new
  		To edit an existing member, select name from drop
  		down lists and click edit
  		To view (in read only mode) an existing member,
  		select name from dropdown list and click show
  		To view the SSS for member (all the trials that they
  		are linked with) click SSS
  		To delete a member, select the member name from
  		the drop down and click delete
  		Please Note
  		If you change the organization name at the
  		organization level, the site level and the member
  		level DOES NOT AUTOMATICALLY CHANGE.
  		You must click Site and Member again to ensure
  		the information you are looking at is relevant to the
  		site that you are viewing
  		To view the SSS for and org (all the trials that they
  		are linked with) click SSS
  		To delete an org, select the org name from the drop
  		down and click delete
  SSS Search		Mini search for CTO Issues
  Criteria		Results are always shown as CTO Number, Org
  		Name, Site Name, Physician, Specialty, Phone,
  		Fax, Sponsor/CRO, Status, Last Change, Access to
  		SSS
  		You can search by
  		Tracking Number
  		Organization Name
  		Site Name
  		Physician Name
  		The more information you enter the more limited
  		your search
  		After you enter the search criteria, click find
  		To get to CTO admin, click CTO
  		To reset search criteria, click reset
  	Passwords	Click Passwords Link
  		Select the organization that you want to get
  		passwords for
  		Click Update
  		Make changes and to save click update
  		To print, click print
  		To export to XLS, click export to XLS
  	Tracking of Web	These are tracked by
  	Site Changes	SSS changes
  		SQQ changes
  		Profile changes
  		It tracks-Tracking number, Physician, Site, Org,
  		Date and Time of change, Location of change
  		(form name and page)
  	Physician History	View which CTO have been sent to a physician and
  		whether they responded (yes or no)
  		Search by name, site, organization or institution
  		(for ORO doctors)
  		Limit as much as you want, more info, more
  		limited search, another wild card search
  		Hit Find
  		Then select which physician and click View
  		History
  		History shown as CTOs offered responded Yes/No
  		OROs offered responded Yes/No
  	Sponsor Requests
  	Results of tell us
  	about your needs
  	Marketer Requests
  	Results of See what
  	we can do for you

• Various other enhancements can be made to the present invention. They will now be set forth.

• Functionality	Description
  Best Practices	Extension of the benchmarking capability, this would be accessible to
  Across All Sites	members. Based on benchmarking metrics, those sites with the best
  Benchmarked	practices will be identified by the service, contacted and interviewed on
  	how they obtained the results in this trial. This information will be shared
  	confidentially with other sites in the same protocol. This will promote
  	information exchange amongst sites, help research naive sites, or poorer
  	performing sites to achieve better results on studies, and identify problems
  	before a study closeout situation occurs
  Secure Bulletin	Each clinical trial listed on Rapidtrials and whose status is on-going will
  Board	have a one (1) way (from the service outboard) Bulletin Board where
  	sponsors can post information about a study including Q&A type
  	information In addition, Sponsor project managers can use the bulletin
  	Board to share information about the study on a on-going basis
  Rapid Budget	Separate Web Module accessible from the current website (rapidtrials.com).
  	Members pay a yearly fee, billed monthly. They can apply for membership
  	via the website (rapidtrials.com), with payment accepted via credit card. A
  	new user will be required to complete an activation form; this will collect
  	basic data on the physician and his organization. The module will ask them
  	questions about the type of study they wish to budget for and which
  	procedures are involved. Users receive a high, average, low, and your site
  	(which allows them to view what they charged for the procedure the last
  	time they used the system). The system then asks them to choose a price for
  	each procedure, this feeds into a basic per patient clinical trial specific study
  	budget template which when they have completed choosing their ranges
  	they can print the complete budget worksheet from the website. This
  	information then updates the underlying sequel table, so it will be available
  	to be used in the calculation for the next user.
  RapidTraining	Current Training Program owned by the service is for Novice Sites and or
  	as a refresher course for experienced sites. Currently we have the program
  	on CD and will Migrate the CD based training program to the Web as a
  	standalone serviced
  Rapid Meeting	Investigator CD platform currently exists. Will be migrated to the Web.
  Rapidpatient	This will be a guide Clinical Research sites in selecting strategies and
  Recruitment	tactics to aid in the clinical trial patient recruitment and retention activities.
  	Based upon a users description of the patient recruitment and retention
  	objectives they are attempting to support, the Rapidtrials web module will
  	suggest appropriate tactics to support the objectives. This module will also
  	include IRB/FDA regulations governing patient recruitment advertising and
  	recruitment guidelines. This module of the Rapidtrials website will be a
  	portal for ordering mugs, t-shirts, ads, media buying, plaques and other
  	promotional items through the service to enhance patient recruitment and
  	retention in clinical trials. A catalog of items, which are IRB/FDA
  	compliant that they can order through us.
  Rapid Assessment	A Rapidtrials web module that uses a psycho-behavioral assessment
  	(similar to Myers Briggs) that has been validated by the service using
  	historical performance and behavioral assessment response correlation's to
  	identify sites with a high probability of succeeding in clinical trials.
  	Investigators and coordinators will complete this behavioral assessment on-
  	line as a predictive tool for the practice of future success in clinical trials.
  	Gaps in attributes will be identified for Sites as a means of guiding them in
  	clinical research program recruitment. For sponsors involved in site
  	selection, or preparing to invest in site development it will give them
  	another performance indicator prior to selecting sites to participate in a
  	clinical trial.
  Industry	Generated by data entered into members organization, site and Investigator
  Benchmarking	profiles, these benchmarks will be displayed by Type of Organization (I.e.
  	solo practice, SMO etc): Total number of protocols per year, Total grant
  	value per protocol, total number of patients enrolled in a clinical trial/year,
  	total number of Study coordinators, total number of sites doing research,
  	Total number of Patients per study coordinator FTE's, Average number of
  	Patients per year, Number of Physicians, Number of PI's, Overhead as a
  	percentage of total per patient budget, Study Coordinator costs as a
  	percentage of Total per patient budget, Investigator Fees as a percentage of
  	total per patient budget, Procedure, lab fees as a percentage of total per
  	patient budget, total number of sponsors worked for/year, Total number of
  	CROs/year, Actual Enrollment/Enrollment
  	Goal.
  Site Capabilities	Data capture approved by field based consultants to gather information on
  Assessment Data	sites developing research programs or preparing to participate in clinical
  Capture and	trial. Migration of proprietary data capture tools to the web.
  Reporting
  Site Operations	Data capture pages used by field based consultants to gather information on
  Specialists Site	sites developing research programs or preparing to participate in clinical
  Development	trial. Migration of proprietary data capture tools to the web. This is the
  eWorkbook	same as the above.
  Site Operations	Data Capture Pages, tools and presentations to use in preparing for and
  Specialists Site	monitoring site performance on a clinical trial. Migration of Proprietary
  Management	Data Capture tools to the web
  eWorkbook

• While a preferred embodiment of the present invention has been set forth in detail, those skilled in the art who have reviewed the present disclosure will readily appreciate that other embodiments can be realized within the scope of the present invention. For example, the utility of the invention is not limited to the medical field. Also, any benchmarks can be calculated, in which case the forms for collecting the data are modified accordingly. Further, the benchmarks can be displayed as text, as any suitable chart, or as a combination of the two. In addition, either the Web server or the database server can incorporate the ability to handle payments from one participant to another, as well as from participants to the company operating the servers. Moreover, any mention of a specific software package (e.g., Microsoft Excel) should be construed as illustrative rather than limiting. Therefore, the present invention should be construed as limited only by the appended claims.

Claims (19)

What is claimed is:

1. A system, comprising:

a database server for (i) providing a user interface for capturing investigator and research site metrics for a plurality of research sites and a plurality of investigators who are participating in a clinical research trial, such metrics including at least one of time to first patient enrolled, total patients enrolled after the first 30 days, actual enrollment as a percentage of the enrollment goal, enrollment rate, screen failure rate, completion rate, per-patient budget, number of queries per patient, enrollment as a percentage of patients screened, and elapsed time from irb submission to irb approval, (ii) storing said collected investigator and research site metrics useful at least for calculating benchmarking information regarding the conduct of said clinical research trial; and (iii) calculating said benchmarking information for each of said plurality of investigators and each of said plurality of clinical research sites participating in said clinical research trial using said collected investigator and research site metrics for said clinical research trial, said benchmarking information comprising information comparing each of said plurality of clinical research sites and each of said plurality of investigators to all clinical research sites and all investigators participating in said clinical research trial; and

a communication server, in communication with said database server, for providing a user interface for communicating some or all of said calculated benchmarking information to one or more of said plurality of investigators and one or more of said plurality of clinical research sites, said calculated benchmarking information being available after said investigator and research site metrics are received by said database server.

2. The system ofclaim 1, wherein the benchmarking information comprises investigator and research metrics continually received by said database server during the clinical research trial.

3. The system ofclaim 2, wherein the benchmarking information further comprises investigator and research site metrics received by said database server at a beginning of the clinical research trial, throughout the clinical trial, and at an end of the clinical research trial.

4. The system ofclaim 2, wherein the benchmarking information comprises a comparison between the benchmarks of a variety of investigator and research site metrics for the clinical research trial and the benchmarks for other clinical research sites involved in the same clinical research trial.

5. The system ofclaim 2, wherein the benchmarking information further comprises investigator and research site metrics received by said database server at a beginning of the clinical research trial, throughout the clinical trial, and at an end of the clinical research trial, aggregated for viewing by a sponsor or representatives of a sponsor.

6. An article of manufacture comprising:

a non-transitory computer-readable storage medium; and

instructions stored on the non-transitory computer-readable storage medium, the instructions comprising:

(a) providing a user interface for collecting investigator and research site metrics on a database server for a plurality of research sites and a plurality of investigators participating in a clinical research trial, such metrics including at least one of time to first patient enrolled, total patients enrolled after the first 30 days, actual enrollment as a percentage of the enrollment goal, enrollment rate, screen failure rate, completion rate, per-patient budget, number of queries per patient, enrollment as a percentage of patients screened, and elapsed time from irb submission to irb approval;

(b) storing on said database server said collected investigator and research site metrics useful at least for calculating benchmarking information regarding conduct of said clinical research trial; and

(c) automatically calculating on said database server said benchmarking information for each of said plurality of investigators and each of said plurality of clinical research sites participating in said clinical research trial using said collected investigator and research site metrics for said clinical research trial, said benchmarking information comprising information comparing each of said plurality of clinical research sites and each of said plurality of investigators to clinical research sites and investigators participating in said clinical research trial.

7. The article of manufacture ofclaim 6, wherein said instructions further comprise:

(d) providing a user interface for communicating some or all of said calculated benchmarking information to one or more of said plurality of investigators and one or more of said plurality of clinical research sites, said calculated benchmarking information being viewable after said collected investigator and research site metrics are received by said database server.

8. The article of manufacture ofclaim 7, wherein said collected investigator and research site metrics stored on said database server comprise metrics received by said database server at multiple times during the clinical research trial in order to update the calculated benchmarking information.

9. The article of manufacture ofclaim 8, wherein said collected investigator and research site metrics stored on said database server comprise metrics received at regular time intervals during the clinical research trial updated at any time once the clinical research trial has begun, and wherein updated benchmarking information is viewable automatically as the benchmarking information is updated throughout the duration of the clinical research trial.

10. The article of manufacture ofclaim 9, wherein said collected investigator and research site metrics stored on said database server comprise metrics received at a beginning of the clinical research trial, intervals throughout the clinical research trial, and at an end of the clinical research trial, aggregated for viewing by a sponsor or representatives of a sponsor.

11. The article of manufacture ofclaim 9, wherein said collected investigator and research site metrics stored on said database server further comprise metrics received at a beginning of the clinical research trial, intervals throughout the clinical research trial, and at an end of the clinical research trial.

12. The article of manufacture ofclaim 6, wherein the benchmarking information comprises a comparison between the benchmarks of a variety of collected investigator and research site metrics for the clinical research trial of one clinical research site to other clinical research sites involved in the same clinical research trial.

13. A method, comprising the steps of:

(a) providing a user interface for collecting investigator and research site metrics on a database server for a plurality of research sites and a plurality of investigators participating in a clinical research trial, such metrics including at least one of time to first patient enrolled, total patients enrolled after the first 30 days, actual enrollment as a percentage of the enrollment goal, enrollment rate, screen failure rate, completion rate, per-patient budget, number of queries per patient, enrollment as a percentage of patients screened, and elapsed time from irb submission to irb approval;

(b) storing on said database server said collected investigator and research site metrics useful at least for calculating benchmarking information regarding conduct of said clinical research trial; and

(c) automatically calculating on said database server said benchmarking information for each of said plurality of investigators and each of said plurality of clinical research sites participating in said clinical research trial using said collected investigator and research site metrics for said clinical research trial, said benchmarking information comprising information comparing each of said plurality of clinical research sites and each of said plurality of investigators to clinical research sites and investigators participating in said clinical research trial.

14. The method ofclaim 13, further comprising:

(d) providing a user interface for communicating some or all of said calculated benchmarking information in real time to one or more of said plurality of investigators and one or more of said plurality of clinical research sites, said calculated benchmarking information being viewable immediately after said collected investigator and research site metrics are received by said database server.

15. The method ofclaim 14, wherein said collected investigator and research site metrics stored on said database server comprise metrics received by said database server at multiple times during the clinical research trial in order to update the calculated benchmarking information.

16. The method ofclaim 15, wherein said collected investigator and research site metrics stored on said database server comprise metrics received at regular time intervals during the clinical research trial updated at any time once the clinical research trial has begun, and wherein updated benchmarking information is viewable automatically as the benchmarking information is updated throughout the duration of the clinical research trial.

17. The method ofclaim 16, wherein said collected investigator and research site metrics stored on said database server comprise metrics received at a beginning of the clinical research trial, intervals throughout the clinical research trial, and at an end of the clinical research trial, aggregated for viewing by a sponsor or representatives of a sponsor.

18. The method ofclaim 16, wherein said collected investigator and research site metrics stored on said database server further comprise metrics received at a beginning of the clinical research trial, intervals throughout the clinical research trial, and at an end of the clinical research trial.

19. The method ofclaim 13, wherein the benchmarking information comprises a comparison between the benchmarks of a variety of collected investigator and research site metrics for the clinical research trial of one clinical research site to other clinical research sites involved in the same clinical research trial.

Images