Lack of diversity in clinical trials means that the medicines, when approved, may not work for the underrepresented and could harm them. Increasing clinical trial participant diversity demands a conscious, intentional effort. It enables ease of trial access for a broader pool of participants with the potential to speed up trial enrollment. It is also good for business, as the approved drugs can be confidently prescribed to a broader, more diverse patient population.
Data from 1,165 pivotal trials for 550 NDAs and BLAs were collected (FDA approvals 2007 – 2021) and the results show that although the proportion of non-white participants in clinical trials has improved, the results continue to show wide disparities, based on disease prevalence, particularly for patients who identify as black and ‘other’ races.