Surrogate Endpoints In Clinical Trials Bone Of Contention In Cures Draft

Many stakeholders weighing in on the House Energy and Commerce Committee's 21st Century Cures draft bill voiced support for provisions that would allow drug manufacturers to rely more on surrogate endpoints and biomarkers to shorten clinical trials and speed new products to market, but a coalition of research and patient advocates say these proposals would endanger patients and should be struck from the bill. Outgoing FDA Commissioner Margaret Hamburg told the Senate health committee last Tuesday (March 10) that more...