The drive for clinical trial diversity continues to gain steam, with the American Society of Clinical Oncology (ASCO) and Association of Community Cancer Centers (ACCC) the latest organizations to share their own guidance in the form of six new strategies to boost participation rates among racial and ethnic minority populations who have been historically underrepresented in cancer studies.
The guidelines are the latest in a string of industry efforts and agency recommendations escalating the issue, including the FDA's call for drugmakers to create and submit diverse recruitment plans for clinical trials early in the drug development process and partnership between Pfizer and Headlands Research to open research sites in diverse areas.
Now, ASCO and ACCC are asking the research community to demonstrate a clear commitment to improving equity, diversity and inclusion (EDI) in clinical cancer trials through six overarching strategies, per a joint research statement released May 19.
The first: Every cancer patient should have the opportunity to participate in clinical trials. Restrictive eligibility criteria can prevent between 17% and 21% of patients from being eligible for cancer trials, the organizations said. Patient demographics regarding trial screening, participation, reasons for not qualifying or participating, and retention should be continually collected and analyzed, they said.
Second: Trial design should work to ensure participants reflect the racial and ethnic makeup of the broader patient population of the disease being studied.
Third: Trial sponsors, researchers and sites should foster long-standing partnerships with patients, patient advocacy groups and community leaders to help recruit people from racial and ethnic minority populations.
Fourth: Anyone designing or conducting trials should complete recurring EDI education and training. Organizations should routinely evaluate the performance and effectiveness of their EDI programs and policies, and incorporate accountability mechanisms to ensure sustainability.
Fifth: Research stakeholders should invest in programs and policies that increase EDI in trials and their own research workforce.
And lastly, research stakeholders should collect and publish comprehensive data on racial and ethnic diversity of participants when reporting results of trials, programs and interventions.
ASCO and ACCC said they will “work all levels” to advance the recommendations themselves.
The new cancer guidelines focus on persons and communities of color because of systemic racism in healthcare, research and society that have disadvantaged these populations, according to the two organizations.
According to a recent report from the Committee on Improving Representation of Women and Underrepresented Minorities in Clinical Trials and Research, other excluded groups from all clinical trials include members of the LGBTQIA+ community, older adults, pregnant and lactating individuals, and people with disabilities.