White Paper

FDA Expectations For Diversity Inclusion In Clinical Research

Source: Rho

By Sheila N. Bello-Irizarry, PHD, RAC and Lauren Neighbours, PHD, RAC

FDA Expectations For Diversity Inclusion In Clinical Research

FDA recently released a snapshot report showing the diversity of clinical trial participants in studies conducted in 2015 and 2016. Out of over 31,000 patients who participated in clinical trials for novel products in 2016, 48% of the study participants were women, which was an increase from 40% in 2015. An increase in clinical trial participation of African Americans was also observed from 2015 to 2016 (i.e., 5% in 2015 vs. 7% in 2016). However, Asian subject participation in clinical studies decreased 1% between 2015 and 2016 (from 12% to 11%, respectively). Overall, the trend towards increasing the diversity of clinical trial participants is encouraging, but a continued effort is needed to keep moving in the right direction.