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Coming Soon: Faster, Yet Still Safe, Clinical Trials

...The FDA is also investigating whether time-to-disease-relapse might be a good predictor of survival for patients battling metastatic colon cancer.If either of those efforts ends positively, the result could be much shorter - yet still accurate - clinical trials for drugs to fight two leading cancer killers.

And experts believe surrogate markers might also serve as endpoints for trials for other forms of disease, including autoimmune disorders and infections such as HIV.The usually conservative FDA has been unusually proactive when it comes to surrogate endpoints, said Radich, who has recently attended agency-sponsored symposiums on the topic as it relates to leukemia research.In fact, in a statement released March 16, the agency listed "biomarkers" as one of the key planks in its "Critical Path Initiative" (CPI), which is aimed at speeding up clinical trials.In the statement, Dr.

Janet Woodcock, FDA's deputy commissioner for operations and head of the initiative, said that "most researchers agree that a new generation of predictive markers would dramatically improve the efficiency of product development, help identify safety problems before a product is on the market (and even before it is tested in humans), and facilitate the development of new types of clinical trials that will produce better data faster."So, are surrogate endpoints the future of medical research?

"The short answer is, 'yes,' " Doroshow ...