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April 12, 2019updated 09 Aug 2019 9:36am

FDA, Brigham and Women’s Hospital expand RCT DUPLICATE project

The US Food & Drug Administration (FDA) and Brigham and Women's Hospital have expanded their previous RCT DUPLICATE demonstration project to predict the results of seven Phase IV trials that are currently ongoing.

As part of the project, the researchers will, for the first time, estimate the results of randomised controlled trials that have not yet concluded.

The project builds on the original scope of the programme to use real-world evidence (RWE) to attempt to replicate the results of 30 randomised controlled trials (RCTs) that are concluded.

It will inform the FDA’s standards for using RWE in regulatory decision-making and will identify when and where RWE can provide estimates of treatment safety and efficacy for supplemental new drug applications.

Brigham and Women’s Hospital Harvard Medical School medicine assistant professor Jessica Franklin said: “Predicting the results of clinical trials before they’re completed is important for showing that in certain circumstances real-world evidence could potentially substitute for a trial.

“This additional work will be vital as we develop a process model for the implementation of regulatory-grade RWE studies.”

The seven additional studies will be registered on clinicaltrials.gov. FDA will get direct access to all study components, processes, and results.

Aetion is training FDA staff on its Aetion Evidence platform to enable them to work with its technology to review a completed RWE study.

The RCT DUPLICATE project is currently in its implementation phase and anticipates interim results in the middle of this year and full results at the end of next year.

The project is funded by the FDA’s Center for Drug Evaluation and Research (CDER) and is led by its Office of Medical Policy (OMP).

RCT DUPLICATE researchers also secured funding from the National Heart, Lung, and Blood Institute at the National Institutes of Health to conduct real-world data analyses on more than 25 cardiovascular studies.

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