In a congressionally mandated report on diversity in clinical trials, the National Academies of Sciences, Engineering and Medicine (NASEM) recommends the FDA require drug sponsors to file an in-depth recruitment strategy, either before or with their investigational new drug (IND) or investigational device exemption (IDE) applications, that details how they intend to make their trial population reflective of the disease or condition’s demographics.

Bristol Myers Squibb (BMS) said that its late-stage trial of Opdivo (nivolumab) plus Yervoy (ipilimumab) did not meet its goal of improving overall survival compared with standard-of-care treatment in certain patients with untreated unresectable or metastatic urothelial cancer.