System and Method for Conducting Cohort Trials

摘要

A computer-assisted method that includes: receiving data encoding parameters defining a study plan of a clinical trial with more than one participant clinical sites; adding a first cohort to the study plan; adding a second cohort to the study plan, the second cohort having no overlapping patient with the first cohort; subsequent to onset of the clinical trial, receiving de-identified information encoding attributes of participant human subjects at each of the clinical sites; parsing the received de-identified information to map the participant human subjects to a particular cohort of the study plan; in response to receiving update information encoding attributes of the participant human subjects at each of the clinical sites, longitudinally tracking the de-identified participant human subjects as mapped to corresponding cohorts of the study plan while the clinical trial progresses at the clinical sites; and providing analytics of the cohorts of the study plan.

主权项

1. A computer-implemented method to model a clinical trial, the method comprising:
receiving data encoding parameters defining a study plan of the clinical trial with more than one participant clinical sites, the parameters including a total enrollment target of human subjects as well as targeted milestone dates of the study plan, the study plan including more than one cohorts, and the clinical sites having varying capabilities in administering each cohort; adding a first cohort to the study plan, the first cohort characterized by a first set of attributes commonly possessed by a first group of human subjects; specifying the first set of attributes as well as a corresponding target enrollment number of the first group of human patients to define the first cohort; adding a second cohort to the study plan, the second cohort characterized by a second set of attributes commonly possessed by a second group of human subjects, the second set of attributes different from the first set of attributes; specifying the second set of attributes as well as a corresponding target enrollment number of the second group of human patients to define the second cohort, the second group of human subjects having no overlap with the first group of human subjects; subsequent to onset of the clinical trial, receiving, from data servers at the clinical sites, information encoding attributes of participant human subjects at each of the clinical sites, the information devoid of identifier information capable of identifying an individual human subject; parsing the received information to map the participant human subjects to a particular cohort of the study plan; in response to receiving, from the data servers at the clinical sites, update information encoding attributes of the participant human subjects at each of the clinical sites, longitudinally tracking, by a processor, the participant human subjects as mapped to corresponding cohorts of the study plan as the clinical trial progresses at the clinical sites; and providing analytics of the cohorts of the study plan based on the longitudinal tracking.