Posted by Michael Wonder on 19 Sep 2017
Drug development at the portfolio level is important for policy, care decisions and human protections
19 September 2017 - 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.
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.
