Abstract:
A method for matching clinical trials to qualified individuals in which the criteria for a plurality of clinical trials are stored, where each clinical trial describes a course of treatment for a particular illness or disease. Information is obtained from a user to determine whether the user is qualified for one or more of the clinical trials. The clinical trials for which the user qualifies is then presented to the user.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]    This disclosure is based upon, and claims priority from, U.S. patent application Ser. No. 09/615,797 which is related to Provisional U.S. Patent Application No. 60/143,549, filed Jul. 13, 1999, the disclosures of which are incorporated herein by reference. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention is directed to health care, and more particularly to a system and method for matching individuals having various diseases and medical conditions to clinical trials for which they qualify.  
         BACKGROUND OF THE INVENTION  
         [0003]    In the treatment of individuals who have prolonged diseases, such as cancer, or other forms of chronic illness, great strides have been made in recent years. Many chronic illnesses and diseases are better understood through research and advanced technology, which traditionally has correlated to better treatment for those who suffer with these diseases and illnesses. However, further research and testing is still desirable for many of theses diseases and illnesses. Further, known treatments for these diseases and illnesses can be very painful or may not help certain individuals.  
           [0004]    One manner in which the field of medicine has gained valuable knowledge of diseases, while experimenting with new treatments, is through the use of clinical trials. Clinical trials are developed and tested with individuals who qualify as patients for the specific objectives of the respective trials. In each clinical trial a certain type of individual with a defined disease or illness is required. Although new clinical trials are being developed every day, it is difficult to find individuals who qualify for the trials. Also, for those who wish to find new treatments for themselves, family or friends, it becomes extremely difficult to provide each of these people with the information on each clinical trial. Thus, there is a need to provide individuals and medical professionals with a central location from which they may access numerous clinical trials and information, or publish their own clinical trials. Further, there is a need for an easy and accurate way to match individuals to clinical trials and help others find a clinical trial without having to sort through all the clinical trials that are available.  
           [0005]    It is an objective of the present invention to provide an integrated system for providing individuals access to information regarding clinical trials in a manner that is convenient and where specific information is easily obtainable. It is also an objective of the present invention to match individuals with chronic illnesses and diseases to clinical trials for which they qualify.  
         SUMMARY OF THE INVENTION  
         [0006]    In accordance with the present invention, individuals seeking new treatments for diseases or illnesses that they may suffer, or someone they know may be suffering from, are provided with a central location that allows the user to peruse numerous clinical trials or be matched to the clinical trials for which they qualify. This is achieved by a system that brings sponsors of clinical trials, professionals in the medical field, and individuals seeking clinical trials and information, together in an organized manner. Information is collected from individuals, sponsors and medical professionals in order to match individuals to clinical trials or provide them with pertinent information.  
           [0007]    An embodiment of the invention describes a method and system for matching clinical trials to qualified individuals. A plurality of clinical trials are stored in a database, where each clinical trial describes a course of treatment for a particular illness or disease. Information is then gathered from individuals or users of the system to determine whether the user is qualified for one or more of the stored clinical trials. A list of all the clinical trials for which it was determined the user was qualified is then presented to the user.  
           [0008]    In further features of the invention, information pertaining to certain clinical trials may be obtained, downloaded or printed for personal use. This information may be provided to a user&#39;s physician for consultation or the physician may provide this information to a patient.  
           [0009]    In another feature of the present invention, registered users may be automatically notified about clinical trials that are newly added to the database of clinical trials for which the users may be a possible candidate, for example via encrypted messages. This eliminates the need for registered users to continually log into the system and have the system do a search for possible matches. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]    [0010]FIG. 1 is a block diagram depicting access alternatives to a clinical trial matching system in accordance with the present invention;  
         [0011]    [0011]FIG. 2 is a diagram illustrating the flow of data from and to users of the matching tool and process;  
         [0012]    [0012]FIG. 3 is a block diagram illustrating the various processes of the matching system;  
         [0013]    FIGS.  4 - 10  are exemplary screen shots of various aspects of the matching system; and  
         [0014]    [0014]FIG. 11 is a block diagram illustrating the logical data structure of the matching database. 
     
    
     DETAILED DESCRIPTION  
       [0015]    The present invention is directed to a system that provides an integrated approach to providing users of the system up-to-date information concerning clinical trials. The system further provides a user with operations that match themselves or another to a clinical trial for which they qualify. To facilitate an understanding of the features and operation of the present invention, it will be described hereinafter with specific reference to its use in the context of the treatment of a diseased patient. It will be appreciated, however, that the practical application of the principles which underlie the invention are not limited to this particular embodiment. Rather, the invention can be employed for a variety of different types of human afflictions for which a clinical trial is developed.  
         [0016]    In a preferred embodiment of the present invention, the system is implemented as a stand alone Internet-based system. However, it should be noted that the system is not limited to being implemented as a stand alone system; the system may also be integrated into various existing or future technologies associated with health care. In the preferred embodiment, the system is a web-based interactive system. The system is comprised of several processes. FIG. 1 illustrates exemplary points of access for a matching system  110  that employs the principles of the invention. The matching system may be easily integrated into other systems that enable them to access the clinical trial data. Included in the access points are a system home page  120 , a disease specific home page  130 , integrated care management application  140 , partner sites  150  and licensed client sites  160 . An advantage to the integration abilities of the matching system is that it allows sites such as the disease specific sites  130  to have access to relevant data. Thus, an individual who might not look to the system home page may look to a home page in the chronic disease area and there find a link to the matching system.  
         [0017]    Once access has been obtained to the system, data may be transferred from and to the user. An exemplary diagram of the data flow is illustrated in FIG. 2. The user of the matching system may be an individual  210  seeking information or searching for clinical trials. A user of the system may also be a trial sponsor  220 , practitioner  242  or CROs/trial nurse  230 , or any other party that is necessary or interested in the system.  
         [0018]    The sponsor  220  provides the system with all the new trials that are developed and ready for candidates. There may be a few to many sponsors that contribute to the database of clinical trials. Additionally, there may be numerous practitioners  242 , CROs/trial nurses  230  and individuals/family members  210  who use and are linked to the system.  
         [0019]    The matching system  110  includes a database of information that is used to match a trial candidate&#39;s particular conditions with the criteria of specific trials. The database includes a sequence of questions and defined answers that are based upon the criteria  222  and guidelines  224  supplied by the trial sponsors  220 . Some of the questions and answers may be general in nature, and are designed to identify broad categories of trials for which a candidate may qualify. For instance, one question may ask for a candidate&#39;s age, and its defined answers may be selected ranges, e.g. 35-39, 40-44, 45-49, etc. Other questions are specific to the clinical details of a particular trial, and include the criteria for both inclusion into and exclusion from the trial. For example, one question for cancer-related trials may ask about the size of the candidate&#39;s tumor, and the defined answers may provide different ranges of sizes that are related to the criteria of one or more specific trials. Other questions directed to exclusion factors may ask whether the candidate has had prior chemotherapy or radiation treatments, and whether the cancer has metastasized at another site.  
         [0020]    Hence, the questions and defined answers function to convert trial-specific criteria into a format that can be readily understood by members of the general public. These questions and answers can be prepared by a person who is skilled in the relevant disease which is the subject of the trial, such as an oncology nurse.  
         [0021]    Once the database of questions and answers has been prepared, the matching process begins by obtaining information from an individual seeking a clinical trial. This information may come from, for example, the individual or from a family member  210  or from the practitioner  242  of the individual. Assessment questions  216  or  248  from the database are presented to the user in order to determine what clinical trial, if any, the individual in question may qualify for. The response to the assessment questions  214  and  252  are returned to the system  110 . Preferably, the questions are organized and presented in an interactive manner, so that the particular defined answer that is selected in response to a given question determines the next question or series of questions to be presented as part of the assessment process. Alternatively, the user may provide the system  110  with clinical information  212  or  254  that would enable the system to identify clinical trials that correlates to the clinical information received.  
         [0022]    Upon receiving the assessment response  214  or  252  and/or the clinical information  212  or  254 , the system  110  may then use that information to match the potential patient to possible clinical trials. The assessment responses and clinical information are checked against the clinical trial information received. For instance, the responses to the questions can be used to construct a query which is presented to the database. For this purpose, the database is preferably constructed with a PDQ format, to provide for efficient searching in response to a query having a number of elements. If a match is found, meaning that the potential patient meets the criteria for the a particular clinical trial, this information is sent back to the trial sponsor  220  and the CROs/trial nurse  230  by way of trial candidate identifications  226  and  232 . At the same time information pertaining to the trial itself is sent to the patient or family member  210 , and/or practitioner  242 . Trial criteria  246  and trial guidelines  244  may be sent directly to the practitioner  242 . From this information, the practitioner  242  may determine if one of his/her patients qualifies for a clinical trial, at which point this information may be sent back to system  110  and passed on to the trial sponsor  220  or CROs/trial nurse  230 .  
         [0023]    The matching system is comprised of multiple processes. Each of the individual processes are components that may be reconfigured to produce new and unique products. A more detailed description of the matching system and it processes is discussed hereinafter with reference to FIG. 3 and FIGS.  4 - 10 . FIGS.  4 - 10  are exemplary screen shots that may be utilized on the matching system, for instance, as web pages. The first process appertains to the login of users in the system. There are two different logins, one for a registered user  305  and another for a guest user  315 . The guest user  315  logs in as a guest and does not have to provide additional information. A registered user logs in by providing an email address and password  310 . A screen shot of the registered user login is shown in FIG. 4. After entering the email address and password in the appropriate places, the user may click the login button  420  which calls up the next screen. If a user is not registered, the user may click on the Register Now button  410  at which point information is taken from the user and the user becomes registered. It should be noted that any type of information that distinguishes one user from another may be used as a registered user&#39;s login data.  
         [0024]    After a user is logged in, an initial assessment  320  is prompted. The initial assessment  320  is comprised of a short questionnaire that is intended to gather information that will immediately narrow the list of trials for which the user may be a potential candidate. Different assessments may be set up by disease type in order to obtain the most relevant information. Generally, the initial assessment  320  gathers information about the specific condition for which the match process should search, for as well as basic demographic information such as age, gender and geographic region. FIG. 5 is an exemplary screen shot of the initial assessment questionnaire. Some of the questions, such as Question  3  in this example, include a drop-down menu  430  of the answers which have been predefined for the particular question. In this case, the answers define general categories of disease sites, e.g. brain, breast, lung, etc. The questions may vary according the different type of information necessary to accurately match a candidate to a clinical trial. The match process  325  constructs a query from the answers to assessment questions, which is applied to match criteria defined for each trial. If all criteria are met, a possible match is returned  330 . If some, but not all of the criteria are met and no criteria are eliminated by the answers to exclusion questions, then a match result of “insufficient data” is rendered. At this point, the user may proceed to an assessment that is specific to a particular clinical trial, view documentation about a specific trial, view a list of all trials listed in the system database, or register for additional services.  
         [0025]    Only the trials that match the user or require more information are displayed for viewing by the user. FIG. 6 is an exemplary screen shot of initial match results corresponding to the initial assessment  320 . Information pertaining to the matched clinical trials is displayed on this page. The user has the option to click on any of the matched clinical trials, to display more information about that trial. If additional information is needed beyond the information already provided in the initial assessment  320 , then the trial may indicate that more data is needed by stating that there is “insufficient data”.  
         [0026]    If the match process indicates that there is insufficient data to determine whether the person is a candidate for a particular trial, then the user may proceed to the trial specific assessment  340 . At the trial specific assessment  340  the user is prompted with a series of additional questions designed specifically to assess the user&#39;s eligibility to participate in the selected trial. This questionnaire is comprised of more detailed questions than those asked in the initial assessment  320 . Specifically, the questionnaire may ask questions concerned with the medical history and clinical conditions of the diseased person. If a question is asked that was previously answered in earlier questionnaires, then that answer is automatically displayed. An additional feature of the trial specific assessment is the answer history button  440 , as shown in FIG. 7. This button allows the user to look at the history of the answers that were provided to a specific question. Once all the questions have been answered, the user may click the update button which stores their answers and starts the match process  325 . At this point a new set of match results  330  may be displayed. The match results presented are the same as the first set of match results. However, if a prior match had resulted in a “possible match” or “insufficient data” condition and the current responses definitely exclude the user as a match, then that trial may appear under the heading of “Match Criteria Not Met”. FIG. 8 is an exemplary screen shot of the match results  330  showing two clinical trials in which, after the second assessment, the candidate no longer meets the criteria.  
         [0027]    The user has a second option when a notice of insufficient data is returned in response to the initial assessment  320 . Rather than answer the trial-specific questions, the user may display the trial documentation  355  for any clinical trial that was returned. Therefore, the user may obtain additional information about the trials in which the user may be a possible candidate.  
         [0028]    From the displayed match results  330  there are several other options that a user may wish to pursue. If no match is found the user has three options. From junction  350 , the user may return to the home page  370 , review a master list of clinical trials  365  and/or begin the registration process  360  if not already registered. If a possible match was identified in which further data is not required, at junction  335  the user may display that trial documentation  355 , review the master list of trials  365  and/or start the registration process  360 .  
         [0029]    When a user chooses to begin the registration process  360 , that user may need to enter personal information. The personal information collected may include name, address, telephone number and email address. However, additional information about the user may also be collected. In a preferred embodiment, the email address is used as the user name. The user name is the name used when logging in as a registered user. During the collection of information the user will also be prompted to submit a password. This password will be used in conjunction with the user name to allow access to the matching system as a registered user. FIG. 9 is an exemplary screen shot of a registered user information page. FIG. 9 is an example of how information pertaining to the registered user may be obtained.  
         [0030]    The registered user information collected is attached to the medical history which was collected as part of the assessment questionnaires  320  and  340 . Periodically the matching system can run the assessment information against the trial database to determine if the diseased person matches the criteria of new trials that have been submitted. If the information indicates that there is a possible match, a message may be sent to the registered user that provides that user with information about the matched trials.  
         [0031]    As a registered user, an individual may click on the registered user icon when revisiting the system homepage. Users may be prompted to enter an email address and password at which point they may gain access to their personal folders. A user may cancel registration at any time. If a user forgets a password, he or she may request that it be e-mailed to them, thereby eliminating the need for the user to register again. To maintain registered status a user may be required to return periodically to update and review their records. If a user does not perform these periodic updates and reviews, they may be taken off registered status and the automatic notifications may discontinue. In an embodiment of the present invention an email message will be sent to all active registrants whose accounts are near expiration. The message may include hyperlink and/or address to the user-specific information page within the matching system, so that they can resubmit or confirm their medical history information. From the registration process  360 , the user may review the list of master trials  365  or return to the system homepage  370 .  
         [0032]    The trial documentation display  355  provides a user with the ability to view a document that may include a description of the trial, criteria for the trial, protocol number, trial sponsor and contacts. It should be noted that other information pertaining to the clinical trial may also be provided to the user. All this information is preferably available in a printable format as well, so that it can be printed and presented to the user&#39;s current physician. FIG. 10 is an exemplary screen shot of displayed information about a particular clinical trial. The displayed data provides users with enough information to determine if they would qualify for this particular trial or if the trial interests them. If the trial interests the user and it has been determined that they may be a potential candidate, then the user can contact the trial sponsor directly in order to participate in the clinical trial. Thus, the individual engaging in the trial may have a direct line of communication with the sponsors.  
         [0033]    The master list of trials  365  contains all clinical trials in the matching system. Therefore a user may peruse the list of trials and the information that it contains in order to find a specific trial or a clinical trial that is of interest. After completing the review of the master list of trials  365 , the user may return to the homepage  370  or return to previously viewed areas, such as the registration process  360  or trial display information  355 .  
         [0034]    The matching system may be employed as a web based system for use on the Internet. In order to provide the security for individuals using the matching system and particulary those individuals who enter information, the system preferably employs the use of encryption technologies, for example, 128-bit encryption. Along with the encryption, no identifying information is retained within the system, unless authorized by the user through the registration process. Being available on the Internet allows the system to be accessible to a wide variety of people across the world. The system may be set up to be accessible through various host sites. An embodiment of the present invention allows the system to be connected to an integrated care management system of the type described in application Ser. No. 09/615,797. This allows those users of the integrated care management system easy access to clinical trial information provided by the matching system. It also provides a pool of individuals against which the criteria for specific trials can be compared, to identify possible candidates.  
         [0035]    [0035]FIG. 11 illustrates the logical data structure of the system database. The member table  510  may include the list of all registered users and members. The member demographics table  505  may include all data associated with the registered users. This data corresponds to the users/members stored in member table  510 . The case table  515  may contain information concerning the individual cases surrounding different diseases and illnesses. Information pertaining to these individual cases are contained in the case assessment table  565 . The questions that are used in the assessments for the different diseases and illnesses are stored in the assessment question table  555 . The predefined answers to those questions are contained in the valid answers table  560 . The assessment layout table  570  contains the proper layouts for the many different assessments. The information pertaining to the clinical trials are stored in the clinical trial detail table  525 , clinical trial sponsor table  530  and clinical trial contact table  545 . The match history table  520  contains the prior matches that were made between users and clinical trials. The assessment history table  535  contains the prior answers given and questions asked in each assessment taken for each user. The clinical trial match table  540  holds the clinical trials that match a user after the user has provided information in one of the assessments.  
         [0036]    While this invention has been described in conjunction with exemplary embodiments outlined above, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, the exemplary embodiments of the invention may be made without departing from the spirit and scope of the invention.