STAT

Opinion: Real-world data can help make better drugs and do it faster

Relying solely on clinical trials to demonstrate the safety and effectiveness of new drugs can be risky. Real-world data can help.

Clinical trials have traditionally served as the gold standard for developing and testing new drugs and devices. Relying solely on them to demonstrate safety and effectiveness, though, can be risky. That’s why we need greater use of real-world data.

Take, for example, the diet drugs fenfluramine and dexfenfluramine (when combined with phentermine they were commonly known as fen-phen). Data collected after they received FDA approval showed a strong association between use of these drugs and cardiovascular problems, and they were ultimately pulled from the market.

The beauty of clinical trials is that they provide a standardized approach to developing a medical treatment within carefully prescribed conditions. The downside is that can help overcome these limitations and mitigate risk. That’s why the pharmaceutical industry needs to embrace it more strongly.

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