Registration studies — when should patients be deemed ineligible for aggressive therapy?

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The approval of therapeutic agents that are tested in patients deemed ineligible for intensive or aggressive therapy is increasingly popular. This approach enables comparisons of novel therapies with less-aggressive agents, as well as data from nonrandomized studies to be used for market authorization. Herein, we discuss three mechanisms that could be adopted to avoid the temptation of applying this strategy excessively.

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The work of V.P. is funded by the Laura and John Arnold Foundation.

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Correspondence to Vinay Prasad.

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Competing interests

R.J.C. reports receiving consulting fees from Syros. V.P. receives royalties from his book Ending Medical Reversal, has received honoraria for Grand Rounds or lectures from several universities, medical centres, non-profit groups and professional societies and is a writer for Medscape. J.G. declares no competing interests.

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