Abstract:
A system and method provide dosage information from past trials of potential subjects to clinics performing drug research so the clinics can determine if the potential subjects qualify (i.e. have waited sufficient time) to qualify for second trial. The system provides a clearinghouse that does not divulge the prior trials proprietary information to the requestor. Likewise, the system does not divulge to prior trial holders who is requesting subject information for subsequent trials. Biographical information including biometric identification can be used to identify subjects in the database. A further method allows a subject to confirm the data in the database.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 61/145,384, filed Jan. 16, 2009. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable 
       THE NAMES OF PARTIES TO A JOINT RESEARCH AGREEMENT 
       [0003]    Not Applicable 
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
       [0004]    Not Applicable 
       BACKGROUND OF THE INVENTION 
       [0005]    1. Field of the Invention 
         [0006]    The invention relates to clinical drug trials, and more particularly to screening potential subjects for participation in clinical drug trials. 
         [0007]    2. Description of the Related Art 
         [0008]    A need exists to screen potential drug-trial participants for participation in conflicting trials. In particular, there is a need for screening potential participants for sufficient “washing out periods”. 
         [0009]    Potential participants in drug trials may have incentive not to report their participation in other trials that may conflict with subsequent trials. Subjects who are ill and not treatable by available treatments may seek new treatments. Other potential participants enroll in drug studies for the money paid by the drug clinic. Participants seeking more or multiple payments may have an incentive to hide their participation in other trials so that they may enroll in multiple trials simultaneously or in more trials without completing the recommended wash-out period. 
         [0010]    Some drug trials require a certain “wash out time” before the subject can participate in a subsequent trial. “Wash out time” may be the time required for a drug to fully elude from a subject&#39;s body. The wash out time may be the time for a prior drug&#39;s effects to end. 
         [0011]    Under current investigations, medicine researchers (e.g. doctors, clinics, and other decision makers) lack complete prior drug dosing information about potential research participants. Research clinics invest time and money in screening potential participants to detect relevant blood levels and other inclusion/exclusion requirements dictated by clinical studies&#39; protocols. In addition, clinics ask potential participants to make representations about the last time they received dosing of investigational medication. However, despite the current policies in place, there lies the potential that subjects may be enrolled in investigational medicine research studies without meeting proper “wash-out” criteria between dosing due to misrepresentations made by subjects about themselves. 
         [0012]    This is a problem for two reasons. First, participants may be endangering their own health by enrolling in clinical studies without meeting the proper “wash-out” criteria. Secondly, the results of clinical studies may be compromised if the participating subjects have improper levels of foreign drug dosing in their bodies during the clinical research process. 
       BRIEF SUMMARY OF THE INVENTION 
       [0013]    It is accordingly an object of the invention to provide a system for preventing subjects from participating in more than one research study at a time and to provide participating clinics with information needed to determine if a potential subject meets a trial&#39;s criteria of waiting between dosings of investigational medications. 
         [0014]    The invention includes a system known as “Clinical RSVP”. Clinical RSVP stands for Clinical Research Subject Verification Program. The system is an independent web-based clearinghouse that integrates a global central database and the individual identification mechanisms of biometrics and demographics to allow member clinics to access information regarding potential subjects. The system and method also provide a way for potential subjects to be screened without the prior clinic revealing to the subsequent clinic its prior study. Likewise, the system provides a way for the subsequent clinic to screen a subject without informing the prior clinic that it is performing a study. The system and method allow a clinic to view a potential subject&#39;s dosage history that is stored in a managed database. 
         [0015]    Subjects participating in research studies are tracked in a central database. The central database includes the “dosing data” for individuals that have participated in research studies conducted at participating clinics. The dosing data can include the historical dosing dates. The dosing data can include the estimated final dosage date for a study. The dosing data is related to a subject identifier. A subject identifier is a unique identifier for each subject. Preferably, the subject identifier includes at least one immutable data relating to the subject. By including the immutable data, the subject is prevented from lying and creating a new subject identifier to avoid the screening. Examples of immutable data are biometric data, initials, date of birth, gender, and at least a portion of a social security number of the subject. Biometric data can be a fingerprint or retina scan. 
         [0016]    Clinical RSVP is an independent clearinghouse where investigators (i.e. clinics) and other decision makers may submit and track information about potential and existing research participants that is useful for clinical study enrollment decisions. Clinical RSVP is a global application supported by a central database. The relevance of the information stored by Clinical RSVP is increased by the inclusiveness of its network, and the accuracy with which it is submitted. 
         [0017]    The Clinical RSVP utilizes the following elements: Application Software, Logics, an Independent Central Database, Biometric Identification, Demographic Identifiers, Data Encryption, Data Security Processes, Subscribers/Users, Consent Form, and Participating Subject Discrepancy Mechanism. 
         [0018]    Application Software. Clinical RSVP takes the form of an organized collection of computer data and instructions executed on a computer. 
         [0019]    Logics. Clinical RSVP utilizes logical methodology such as restrictions, sequencing, reminders, alerts, and study closing procedures to produce reliable and relevant data while maintaining independence. 
         [0020]    Independent Central Database. Subject identifier data is data used to determine dosing dates and wash-out time periods. The subject identifier data along with other data are stored at a central database. Once submitted, the data is housed independent of Clinical RSVP subscribers. This database serves as a central “clearinghouse” for registered clinics. Clinics will have access to limited data needed to make study enrollment decisions. This database can include any form of data collection stored under any form of support. 
         [0021]    Biometric Identification. Clinical RSVP uses the measurement and recording of the physical characteristics of an individual for use in subsequent personal identification. Clinical RSVP utilizes biometric identification such as a fingerprint scanner to generate a map of an individual. This map is run against a global central database for participant identification purposes. The biometric is also used as a way for participants to verify the dosing dates entered into the database. Participants are instructed on how to provide their biometric in order to confirm that the dose dates are correct. 
         [0022]    Demographic Identifiers. Clinical RSVP collects participant demographic identifiers such as initials, date of birth, sex, and last four digits of social security number to be used for participant identification purposes. 
         [0023]    Data Encryption. The transfer of Clinical RSVP data occurs through encrypted connections. For example, data can be transferred in a TCP/IP Network via a connection supporting Hypertext Transfer Protocol Secure (HTTPS). A Virtual Private Network (VPN) can be used to connect each clinic to the Clinical RSVP. 
         [0024]    Data Security Processes. Clinical RSVP requires effective data security measures. The data security process is summarized in the RSVP Data Security Policy. 
         [0025]    Subscribers/Users. Access to Clinical RSVP data can be controlled user-by-user or by user type. For example, subscribers can be given access to Clinical RSVP data. These subscribers are the party responsible for entering the data, as well as the user of the data. Research clinic subscribers may directly or indirectly compete among each other for clinical studies. Therefore, the database is managed independently of the subscribers. 
         [0026]    Consent Form. Clinical RSVP tracks information about individuals who have given signed consent to have their information included in the database. 
         [0027]    Participating Subject Discrepancy Mechanism. Clinical RSVP utilizes an RSVP Accuracy Validation Form submitted by those individuals who have given signed consent to have their information included in the database to resolve potential participant discrepancies. 
         [0028]    The system can provide a means to comply with laws protecting a subject&#39;s privacy. To comply with federal and state patient privacy laws, potential participants give their consent to be tracked by the RSVP application. Signed Subject consent forms are stored. The clinic itself might retain the consent. Alternatively, the signed consent forms can be stored electronically in the database. The RSVP consent form(s) are required to not violate HIPAA or any other regulatory statutes. If the provider prefers, the clinic can store the signed consent forms. 
         [0029]    With the foregoing and other objects in view there is provided, in accordance with the invention, a system for confirming a subject&#39;s drug dosing history as it relates to that subject&#39;s ability to join a clinical drug study. The system includes an electronic database and a terminal connected to the database. The electronic database stores a subject identifier and the historical drug dosing information that is related to the subject identifier. The terminal accesses the database and is used for entering the subject identifier to be searched in the database in order to confirm the subject&#39;s drug dosing history to be used for making enrollment decisions about the next clinical study. 
         [0030]    In accordance with the objects of the invention, a method for confirming a subject&#39;s ability to join a clinical drug study is also provided. The first step is checking if a subject identifier exists for a prior trial in the database. The next step is checking if the most-recent dosage date and/or estimated final dosage date do not conflict with the protocol of the proposed new trial. 
         [0031]    For verification purposes, the clinic that enters data is related to each dosage record within the database with a unique clinic identifier. The clinic identifier is not published. Only, the database administrator can see which clinic entered a dosage record. If a potential subject challenges the correctness of a dosage record, the new clinic provides an accuracy validation form to the subject. The potential subject completes the accuracy validation form and submits the form to the database administrator. The database administrator then reviews the database, identifies the clinic that entered the data in question, contacts the clinic that entered the dosage information, and requests than an officer within the prior clinic verifies the data. The compliance officer then confirms the data and reports to the database administrator. The database administrator reports to the new clinic. 
         [0032]    Each clinic does not know of the others request. The subsequent clinic cannot see the prior clinic&#39;s dosage data so the identity and study information of the prior clinic is shielded from the subsequent clinic. Likewise, during a verification, the identity of the subsequent clinic is shielded from the prior clinic. The use of a middleman, the database administrator, allows the information to pass without passing information identifying each of the clinics. 
         [0033]    Other features that are considered as characteristic for the invention are set forth in the appended claims. 
         [0034]    Although the invention is illustrated and described herein as embodied in a clinical Research Subject verification program, it is nevertheless not intended to be limited to the details shown, because various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims. 
         [0035]    The construction and method of operation of the invention, however, together with additional objects and advantages thereof will be best understood from the following description of specific embodiments. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
         [0036]      FIG. 1  is schematic diagram showing transfer of information within the system according to the invention. 
           [0037]      FIG. 2  is a flowchart showing a Clinical RSVP Configuration. 
           [0038]      FIG. 3  is a flowchart showing a method for searching the database for a subject. 
           [0039]      FIG. 4  is a flowchart showing a method for reporting enrollment of a subject. 
           [0040]      FIG. 5  is a flowchart showing a method for updating dose dates of a subject. 
           [0041]      FIG. 6  is a flowchart showing a method for reporting a final dose taken. 
           [0042]      FIG. 7  is a flowchart showing a method for accuracy validating. 
           [0043]      FIG. 8  is a schematic drawing of a system according to the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0044]      FIG. 8  shows a preferred embodiment of a system according to the invention. The system which is referred to as “Clinical RSVP” includes a centralized computer database  2  hosted on a computer server  1 . The computer server  1  is connected to clients via a network  4 . Preferably, the network  4  is a TCP/IP network such as the Internet. Connections to the server  1  from the network  4  are secured with passwords, encryption, and other means for securing data communication over a network  4 . Data being communicated across the network  4  is encrypted. A Virtual Private Network (VPN) is a preferred connection between the server  1  and the clients  3 . 
         [0045]    Clinical research facilities are the preferred clients  3 . Each clinical research facility  3  has a computer terminal  5 , or more simply a “terminal”, or workstation or other computer client for accessing the Clinical RSVP server  1  via the Internet  4 . Each clinical research facility  3  is provided credentials (i.e. a username and password) to gain access to the Clinical RSVP server  1  and database  2 . 
         [0046]    Clinical research facilities  3  generate a unique study identification number in the database  2  by executing an RSVP application  6  on the server  1 . 
         [0047]    Clinical research facilities  3  have potential participants sign any and all consent forms  7  necessary to be tracked by Clinical RSVP  10 . 
         [0048]    Clinical research facilities  3  scan potential participant&#39;s fingerprint using a biometric fingerprint scanner  8 . Based on the fingerprint scan, Clinical RSVP  10  then generates a unique biometric identifier number based on a template of the most determinant points of the fingerprint. The clinic  3  also collects the potential participant&#39;s initials, date of birth, sex, and last four digits of social security number to be used as additional participant identifier information. 
         [0049]    Clinical research facilities  3  request that Clinical RSVP compare the identifier information obtained against the identifier information already stored in the central database  2 . 
         [0050]    Within the Clinical RSVP  10 , a search application  11  on the server  1  searches the central database  2  for matches of identifier information, and reports the results of the search to the requesting clinic  3 . 
         [0051]    Clinical research facilities  3  submit data regarding study enrollment and dosing. Data is classified as Clinical Public Data, Clinical Proprietary Data, and Public Company Data. 
         [0052]    Once data is submitted by research facilities, research participants provide their biometric identification to confirm the dosing information about themselves. 
         [0053]    Clinical Public Data is defined as data that all subscribers to Clinical RSVP can access. The disclosure of this data is necessary for achieving the objective of Clinical RSVP. Clinic Public Data includes information that Clinical RSVP is obligated to protect. The value of Clinical RSVP would be destroyed or diminished if such information were disclosed outside the Clinical RSVP network. Some sensitive data necessary to achieve the objective of Clinical RSVP falls into this category. Examples of Clinical Public Data include Most Recent Reported Dose Taken Date, Scheduled Final Dose Date, Enrollment Status, unique biometric identifier number, participant initials, participant date of birth (D.O.B.), participant sex, and participant&#39;s last four digits of their social security number. 
         [0054]    Clinical Proprietary data is any information that derives its economic value from not being disclosed across users or publicly disclosed. It includes information that Clinical RSVP is obligated to protect. The value of Clinical RSVP would be destroyed or diminished if such information were disclosed to others within the Clinical RSVP network or to others outside of the Clinical RSVP network. Examples of Clinical Proprietary Data include data audit trail, optional customized data fields, and unique study identification number. 
         [0055]    Clinical Confidential Data is data not entered into Clinical RSVP but that is used to validate information entered into Clinical RSVP. Clinical confidential data is maintained by individual clinics that are subscribers to Clinical RSVP. This data is never to be communicated to the Clinical RSVP central database. However, for purposes of participant protection, subscribing clinics are required to reference this information to resolve discrepancy in the event that a participant submits an “Accuracy Validation Form”. Clinical RSVP is not obligated to protect this data. Examples of Clinical Confidential Data include full participant name, participant medical information, clinical study name, clinical study enrollment reports, clinical study dosing dates, and clinical study key. 
         [0056]    Public Company Data is defined as data that any entity, either internal or external to Clinical RSVP, can access. The disclosure, use, or destruction of Public Company Data will have limited or no adverse affects on Clinical RSVP nor carry any significant liability. Examples of Public Company Data include readily available news, public list of customers, and marketing information. 
         [0057]      FIG. 1  is a schematic drawing showing the relationship and transfer of information between database administrator  20 , research facility  3 , and research subject  30 . A database administrator  20  manages the Clinical RSVP  10  and the database  2 . A research facility  3  has a terminal  5  that is connected to the database  2 . The research facility  3  enters data  21  including a subject identifier and dosage information into the database  2 . Search results  22  of the database  2  are transmitted from the database  2  to the research facility  3 . A subject  30  files an accuracy validation form  23  with the database administrator  20 . The database administrator  20  transmits the results  24  of the verification to the research subject  30 . The research facility  3  obtains the consent and subject identifier  25  information from the research subject  30 . The research facility  3  provides the research subject with the accuracy validation form  26 . 
         [0058]    In the event a research subject files a RSVP Accuracy Validation form  23 , the clinical research facility  3  is required to conduct an internal investigation, led by the facility&#39;s Accuracy Officer, as to the accuracy of any disputed dosing data. 
         [0059]    Other products that could include our invention is any group of competitors that need to access shared marketplace data that is of the nature of being generated by the users which constitute the competing group, and of which is specific about individual persons. For example, competing clinics, doctors, or hospitals could include an embodiment of Clinical RSVP to track other relevant data about research participants or patients. 
         [0060]    Modifications and substitutions that are merely design choices include the industry under which groups of competitors operate, the specifics of the data being tracked other than data about individual persons, and the permutations of the access to independently stored data. 
         [0061]    The RSVP database program has adequate “encrypting” and data security protection processes. 
         [0062]      FIG. 2  is a flowchart showing a preferred embodiment of the system and method.  FIGS. 3-7  show related parts of the overall system and method. 
         [0063]    As shown in  FIG. 3 , at the time that a research subject  30  comes to the clinic  3  to screen for a research study, the clinic  3  logs to the Clinical RSVP system  10  via a terminal  5  through a website front end on the server  1 . A clinic  3  is a center where subjects  30  may be screened, enrolled, and treated. The clinic  3  can be a research clinic or other place where healthcare is provided. The clinic  3  requests that the potential subject  30  sign a Personal Health Information Authorization Form: i.e. a consent form  7 . 
         [0064]    The clinic  3  will obtain subject identifiers. Preferably, the subject identifiers include an immutable biometric identifier such as a fingerprint or retina scan. A biometric scanner  8  is located at the clinic  3 . The biometric scanner  8  is connected to the terminal  5 . The clinic  3  uses the terminal  5  to transmit the biometric data to the Clinical RSVP. The clinic  3  also obtains biographical data from the subject  30 . The biographical data is information used to identify the subject. Suitable biographical information includes an arbitrary alphanumeric identifier, initials, date of birth, gender, at least a portion of a social security number of the subject. Combinations of the data can be used to uniquely identify each subject  30  within the database  2 . 
         [0065]    If the subject  30  is new within the database  2 , a record is created for the subject  30 . As detailed below, if a record exists in the database for the subject  30 , the dosage information for the subject  30  is output to the clinic  3 . 
         [0066]    The clinic  3  will then make an inquiry to the clinical RSVP database  2  to evaluate if a potential subject  30  has recently been dosed with an investigational medication. The clinic  3  utilizes a biometric identification hardware  8  to generate a unique biometric identifier number to identify the subject  30  and that unique identifier number will be searched in the database  2  to determine the most recent reported dose taken date, and scheduled final dose date (if any) of that potential subject  30 . Also, the gender, date of birth, initials, and last four digits of the potential subject&#39;s social security number, will be obtained for searching the database  2 . 
         [0067]    Immediately prior to enrollment of a subject  30  into a research study, the clinic  3  will provide the RSVP application  10  with unique a unique subject identifier. The subject identifier preferably includes at least one immutable characteristic such as a biometric identifier number, the last four digits of the potential subject&#39;s social security number, gender, date of birth, and initials. The Clinical RSVP  10  will search for the subject identifier in the central database  2  and provide the clinic  3  with the date of inquired subject&#39;s last dose of study medication if a match is found. To protect the identity and subject matter of the prior clinical test, only the dosage information (i.e. most recent dosage and last planned dosage) of the subject  30  is preferably reported. Based on the most recent reported dose taken date and scheduled final dose date, the clinic  3  will decide if the subject  30  qualifies for the research study. 
         [0068]    As shown in  FIG. 4 , if a subject  30  is then enrolled in the research study, the clinic  3  will be required to update the database  2  (through the RSVP application) at, at least, initial dosing and final dosing to reflect the dosage information in the database  2 . The clinic  3  confirms the dosage information before saving the dosage information in the database  2 . 
         [0069]      FIG. 5  shows the steps by which the dosage information is updated in the database  2 . A user (i.e. a clinic  3 ) logs into the Clinical RSVP  10 . The clinic  3  doses the subject  30 . The clinic  3  records in the database  2  the dosage date and updates the anticipated final dosage date, if necessary. The clinic  3  uses the terminal  5  to enter into the database  2 , the dosage information. The subject identifier, which preferably includes biometric data, is used to form a digital signature that is related to the dosing information being entered into the database  2 . The clinic  3  confirms the change to the database  3  and the change is saved. 
         [0070]      FIG. 6  shows a flowchart illustrating a method for reporting a final dose taken by a subject. The clinic  3  begins by using the terminal  5  to login to the Clinical RSVP  10 . A final dose is given to the subject  30 . The clinic  3  updates the database  3  to show the final dose date. The clinic  3  confirms the change before the database  2  is updated. 
         [0071]      FIG. 7  is a flowchart depicting a preferred method for the accuracy of the database to be validated. Before data is validated, data is included in the database. An identifier associated with the study and the clinic  3  where the dosing occurs is generated and stored in the database  2  so as to be able to resolve any potential discrepancies (as claimed by subjects  30 ) that may occur. The clinic  3  and study identifier will not be released outside of the RSVP database and will be used only to resolve discrepancies. 
         [0072]    Individual clinics will maintain all participant dosing history support documentation independent of the database administrator  20 . Therefore, the database administrator  20  or other clinics  3  do not have access to information above and beyond the limited identifiers listed above. In the event of a subject discrepancy (i.e., the subject feels they are being unfairly withheld from the study due to inaccurate dosing date maintained in the system), the clinic  3  rejecting the subject  30  will provide the subject  30  with an RSVP Accuracy Validation form  23 . 
         [0073]    The RSVP Accuracy Validation Form  23  will list the following: date of report, all identifiers in the system, including the most recent reported dose taken date and scheduled final dosing date, phone number to the database administrator  20 , and electronic submission option to the database administrator  20 . In other words, in the event of a subject discrepancy, the subject  30  files an RSVP Accuracy Validation form  23  with the database administrator, who is independent from the clinic that inputted the data. Next, the database administrator searches the database  2  to find the subject identifier and the dosage information, which is being contested. Once obtained, the database administrator  20  sends the clinic  3  that made that data point entry a request. The clinic  3  then conducts an investigation, led by the clinic&#39;s self appointed Accuracy Officer, as to the accuracy of the data under discrepancy. At least initially, the investigation confirms most recent reported dose taken date and schedule final dose date. The clinic  3  is then required to report the results of the investigation to the database administrator  20 . The report confirms the subject&#39;s  30  most recent reported dose taken date and scheduled final dose date. If a mistake is found, the clinic sends corrected information to the Clinical RSVP  10 . The new clinic  3  then may reevaluate the subject  30 . 
         [0074]    Accordingly, the preferred embodiment of the invention allows for a clinic to screen potential test subjects for recent participation in other studies that may compromise the results in the study or the health of the subject.