DISTRIBUTED RANDOMIZATION AND SUPPLY MANAGEMENT IN CLINICAL TRIALS

摘要

A distributed clinical trial system that provides configurability, reusability and integration of randomization for different clinical trials with various electronic data capture (EDC) systems. The distributed clinical trial system includes a method of randomizing subjects in a multi-arm clinical trial. In accordance with a method, a subject identifier and a trial identifier are received from an EDC system. The trial identifier indicates the multi-arm clinical trial and the subject identifier indicates a subject enrolled in the multi-arm clinical trial. A randomization design algorithm for the multi-arm clinical trial is retrieved from a database using the received trial identifier. The randomization design algorithm is executed. The randomization design algorithm randomizes the subject to an arm of the multi-arm clinical trial, assigning the subject identifier to an arm identifier that indicates the arm of the multi-arm clinical trial to which the subject has been randomized

主权项

1. A method of randomizing subjects in a multi-arm clinical trial, the method comprising:
receiving, by a computing system, at least a subject identifier and a trial identifier from an electronic data capture system, the subject identifier indicating a subject enrolled into the multi-arm clinical trial, the trial identifier indicating the multi-arm clinical trial into which the subject is enrolled; selecting at runtime, by the computing system, a randomization design algorithm for the multi-arm clinical trial from a database using the trial identifier, the database storing a plurality of randomization design algorithms associated with respective trial identifiers for a plurality of multi-arm clinical trials; and executing, using the computing system, the randomization design algorithm that randomizes the subject to an arm of the multi-arm clinical trial, the randomization design algorithm assigning the subject identifier to an arm identifier that indicates the arm of the multi-arm clinical trial to which the subject has been randomized.