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The call for achieving representative diversity in clinical trials and development programs is not new — and indeed dates back more than five decades in the United States — but has been amplified over the course of the COVID-19 pandemic as the realities of disparities in health outcomes among diverse populations have become increasingly evident. At the same time, there has been a striking increase in the level of visibility, attention, commitment, and action by multiple stakeholders to address this issue.
The purpose of the research incorporated in this report is to measure the progress that has been made in increasing participation by racial and ethnic groups – with a principal focus on Black/African Americans and Hispanics – in clinical trials. We recognize that “diversity” can be framed in many different ways beyond race and ethnicity, and that there are limitations to what can be measured as well as time lags between action taken and results reported. Nevertheless, we believe that looking at the most recent available information provides a useful evidence base against which future progress can be measured.
We also highlight in this report where we see tangible progress being made, lessons learned and applied, and a positive shift among the many stakeholders involved in pursuing improvements in clinical research representativeness.
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