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THE FDA WANTS TO USE REAL WORLD DATA TO PREDICT CLINICAL TRIAL RESULTS BEFORE COMPLETION

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The FDA has talked about real world evidence (RWE) for a while and now wants to use it to determine the results of clinical trials before they are complete.

“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,” said project lead Jessica Franklin, Ph.D., assistant professor of medicine at Harvard Medical School and a biostatistician at Brigham and Women’s Hospital. “This additional work will be vital as we develop a process model for the implementation of regulatory-grade RWE studies.”

 

FierceBiotech

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