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September 19, 2017

Drug Development at the Portfolio Level Is Important for Policy, Care Decisions and Human Protections

Author Affiliations
  • 1Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada
  • 2Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
JAMA. 2017;318(11):1003-1004. doi:10.1001/jama.2017.11502

The development of a new drug is often portrayed as a series of increasingly demanding clinical trials, performed in patients with a single target condition, as the development program advances toward drug approval. However, rarely does drug development involve a single approach to using a drug. Instead, drugs are tested in multiple clinical trials—many pursued after initial drug approval and licensure—involving different clinical indications or drug combinations. This family of trials could be referred to as a drug development “portfolio.” For example, the portfolio of the anticancer drug sorafenib included 203 clinical trials conducted over 13.2 years, spanning 26 different malignancies and 67 drug combinations.1 A portfolio can be enormous if defined in terms of drug classes. For instance, at least 803 trials are testing checkpoint inhibitors for the treatment of different malignancies.2