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Non-traditional sites a path to more diverse clinical trials, say researchers

Posted by on 25 April 2023
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Efforts to make clinical trials more diverse need to intensify according to researcher, who suggest the EMPACTA study in patients with COVID-19 proves the value of focused recruitment.

The EMPACTA study – funded by Genentech – assessed the impact of the monoclonal antibody drug Tocilizumab in people from underserved and racial and ethnic minority populations who were hospitalized with COVID-19-related pneumonia.

EMPACTA showed tocilizumab reduced the likelihood of progression to the composite outcome of mechanical ventilation or death, but it did not improve survival.

Non-traditional sites

Of more importance – say the authors of the new analysis – was that EMPACTA demonstrated the clear benefits of focused recruitment efforts.

“EMPACTA demonstrated the feasibility of inclusive trials and showed that prioritizing enrolment of patients from under-represented racial and ethnic groups can advance scientific knowledge and improve patient access to beneficial therapies.

“Learnings from intentionally designed dedicated trials targeted at enrolling historically under-represented racial and ethnic populations can be utilized to improve the design of pivotal clinical trials so that enrolled participants are representative of the patients to whom the therapies are targeted.”

They point to the use of non-traditional study sites as key, explaining “The dominant use of academic centers for clinical trial research, along with other barriers, compounds the lack of diversity within scientific research.

“Industry and research organizations must challenge biases and engage non-traditional sites, including public hospitals and rural and community-based institutions, which provide care to underserved patients.”

Team effort

The authors also call on all parties – sponsors, CROs, and patient groups – to work together to make drug research more diverse and representative.

“The main goal of diversity in clinical research is to provide rigorous scientific evidence that is valid and generalizable to all populations, and in doing so provides wider patient access to therapeutic treatments not available outside of clinical research.

“All stakeholders—including government agencies and regulators, CROs, health systems, healthcare providers, investigators, pharmaceutical companies, and patient groups—must proactively challenge the systemic inequities underscoring current research to ensure diversity and inclusion.”


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