Method for creating and using registry of clinical trial participants
Inventors
Efros, Mitchell D. • Weingard, Kerri
Assignees
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Publication Number
US-11568963-B2
Publication Date
2023-01-31
Expiration Date
Abstract
A method of screening participants for a clinical trial by obtaining identifying information chosen from a biometric sample, personal information, physical attributes, and combinations thereof from a prospective participant, optionally generating a unique identifier code, populating a database server with the unique identifier code and participant information and storing the information on non-transitory computer readable media, screening the participant for a clinical trial based on either the unique identifier code and/or participant information and searching for a match with existing participant information in the database server and a plurality of outside databases to determine protocol violations, and determining eligibility of the participant for the clinical trial and preventing the protocol violations. A system for screening participants for a clinical trial and preventing future violations while currently enrolled in a clinical trial.
Core Innovation
The invention relates to a clinical-trial participant registry system and method of screening participants for a clinical trial. The method obtains identifying information from a prospective participant chosen from the group consisting of a biometric sample, personal information, physical attributes, and combinations thereof, and populates a database server with the identifying participant information stored on non-transitory computer readable media.
The identifying information is used by a screening mechanism in electronic communication with the database server to screen the participant. The screening mechanism searches for a match with existing participant information in the database server and a plurality of outside databases, including clinical trial databases, IVRS/IWRS databases, screening/dosing logs, clinical trial management systems (CTMS), databanks that have research subject information, databanks that have information regarding drug/medication use, blood product donation databases, sperm banks, and human by-product databases.
If matching information is found, the invention electronically alerts a research site or clinical trial administration and electronically determines eligibility of the participant for the clinical trial. The screening determines protocol violations based on matching participant information and specified violation categories, including duplicate or concurrent screening, washout or half-life violations, biologic modifier washout violations, exclusionary investigational compound exposure, and additional draw and visit violations.
Claims Coverage
The independent claims are directed to a method of screening participants for a clinical trial and a corresponding system that performs electronic screening, alerting, and protocol-violation prevention. The inventive features center on identifying information ingestion, storage in an electronic database server, searching across internal and multiple outside databases, detecting specified protocol violations, electronically alerting sites or administration, and determining eligibility while preventing protocol violations.
Participant-identifying information for clinical-trial screening
Obtaining identifying information from a prospective participant chosen from the group consisting of a biometric sample, personal information, physical attributes, and combinations thereof.
Database server population and storage
Populating a database server with the identifying participant information and storing the information on non-transitory computer readable media.
Electronic screening across internal database and outside databases to determine protocol violations
Using a screening mechanism in electronic communication with the database server to search for a match with existing participant information in the database server and a plurality of outside databases to determine protocol violations, including duplicate or concurrent screening, washout or half-life violations, biologic modifier washout violations, exclusionary investigational compound exposure, and additional draw and visit violations.
Electronic alerting based on matching information and protocol-violation determination
Electronically alerting a research site or clinical trial administration if the participant is found to have matching information to existing participant information in the database server or outside databases, including determining whether the participant is enrolling multiple times, enrolling in multiple clinical trials at once, or enrolling sooner than a specified mandatory washout period between clinical trials.
Eligibility determination and prevention of protocol violations
Determining eligibility of the participant for the clinical trial and preventing the protocol violations.
Electronic database server with screening mechanism and outside databases
An electronic database server in electronic communication with a server instance for collecting participant information on non-transitory computer readable media, with a screening mechanism for determining eligibility and preventing protocol violations and with a plurality of outside databases.
Alerting mechanism for matching-based protocol-violation outcomes
A server instance including an alerting mechanism for electronically alerting a research site or clinical trial administration if the participant has matching information to existing participant information based on the screening mechanism.
System eligibility determination and protocol-violation prevention
The system determining eligibility of the participant for the clinical trial and preventing the protocol violations.
Across the independent claims, the core coverage centers on collecting prospective participant identifying information, storing it in an electronic database server, screening for matches across internal data and multiple specified outside databases, detecting specified protocol violations, electronically alerting research sites or clinical trial administration based on the screening and protocol-violation outcomes, and determining eligibility while preventing protocol violations.
Stated Advantages
Detecting protocol violations based on matching participant information across internal and outside databases.
Electronically alerting research sites or clinical trial administration when matching information and protocol violations occur.
Determining eligibility of the participant for the clinical trial.
Preventing the protocol violations.
Documented Applications
Screening participants for a clinical trial to prevent protocol violations, including duplicate or multiple enrollment, washout or half-life violations, biologic modifier washout violations, exclusionary investigational compound exposure, excessive trial counts, screen failures, blood draw violations, plasma draw violations, and last-visit violations.
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