An update on progress and results
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.
In this report, we also highlight tangible progress, lessons learned and applied, and a positive shift among the many stakeholders involved in improving clinical research representativeness.
Some key findings:
Disparities in outcomes across different patient groups – defined based on race, ethnicity, gender, age, socio-economic factors, and other factors – are significant and can be attributed to many intersectional drivers related to healthcare awareness, access, and delivery, in addition to the factors associated to genetics
While access and delivery of care are major factors driving disparities in outcomes, a comprehensive clinical development program that addresses diversity and ranges from pre-clinical and exploratory studies through randomized confirmatory trials for safety and efficacy through to post-approval real-world studies can advance understanding of optimal patient care, expand access to care, bring earlier insights, and accelerate innovation
Stakeholders in the U.S. have been focused on improving diversity in clinical trials for at least 30 years, and a dramatic increase in reporting of diversity data has occurred over the past five years.
Based on race/ethnicity data reported, Black/African American and Hispanic participation in trials fall short of 2020 U.S. demographics levels of 13.6% and 18.9% respectively.
Each stakeholder group has made significant commitments to support and enable clinical trials, and increasing clarity around what needs to be done and examples of progress and success cases provide essential building blocks for future progress.
Success cases from sites that consistently over-recruit study participants relative to their demographics highlight some of the critical factors to engage under-represented populations in the clinical trial process
To download the report and find out more you can click on IQVIA’s page here.