Questioning the efficiency of surrogate endpoints

Dr. Vinay Prasad is tackling surrogate endpoints yet again — this time in JAMA Internal Medicine. Surrogate endpoints, of course, are results that show that a drug has some impact — tumor shrinkage, for example. Drugs are often approved on this basis, because it’s generally more efficient. But Prasad’s whole platform has centered around pushing for analysis of overall survival — studying, instead, how patients feel or how long they live. This takes more time. 

But not that much more time, according to the new paper: “Any way you slice it, the time saved by surrogates is not that much,” Prasad and his co-authors argue. It takes about 12 percent longer to conduct a trial that uses overall survival as an endpoint, instead of surrogate endpoints — or about 11 months, when placed in the context of the average development time of cancer drugs, which is 7.3 years.