July 26, 2021
By Amanda Barrell
A lack of racial diversity in clinical trials is a long-standing, well-documented problem that contributes to the stark health inequalities that have been brought into sharp focus by COVID-19.
Tackling it, however, has not been easy, thanks in no small part to the reasons being as complex as they are multi-faceted.
But, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), the country’s biopharmaceutical companies are “committed to learning and leading” in a bid to “address systematic racism and stand up to injustice”.
As part of a programme of work on healthcare equity, the body has developed the first set of industry-wide principles on clinical trial diversity, which came into effect in April.
“The principles are an important step toward greater health equity,” said Stephen J. Ubl, president and chief executive officer at PhRMA.
“We are addressing issues of mistrust and working to reduce systemic issues that deter communities of colour from participating in clinical trials, so that those patients who want to participate, can.”
Pillars of change
In the US, fewer than three per cent of eligible patients participate in clinical trials, a figure that is drastically lower among ethnic minorities living in underserved communities.
It means that we have a lower understanding of how drugs work in these cohorts – a problem that will only get worse as the personalised medicine revolution continues at pace.
PhRMA’s principles form part of the body’s response to this manifestation of systemic racism, which it called “as real as any disease”.
The idea is to enhance education on role of medical research, and raise awareness of clinical trials, while removing barriers to access and participant. The document also states the importance of real-world data in understanding how currently available pharmaceutical products work in different populations.
Ultimately, they talk about the crucial issue of building trust and acknowledging past wrongs.
“Some patients, particularly in Black and Brown communities, may not trust medical research due to historical mistreatment. This includes examples such as the U.S. Public Health Service Syphilis Study at Tuskegee, 1932-1972,” said the authors.
The 40-year trial, which included 600 Black men, was ruled to be unethical in the 1970s, after it emerged syphilis treatment had been withheld in the 1940s, when penicillin was proved curative. It also emerged that informed consent had not been collected.
“That study’s serious mistakes and moral breaches led to major changes in how clinical trials are conducted in order to protect the rights, safety, and well-being of clinical trial participants,” said the principles, reiterating that the rights of today’s research participants are protected by law and by ethics committees.
The principles, which can be voluntary adopted by industry players, set out a number of ways in which trust can be nurtured. They include improved outreach and building workforces that look like the communities researchers wish to represent.
That means partnering with health and community advocacy groups to increase clinical trial awareness and capitalise on potential opportunities for participation.
“The lack of participation by historically understudied populations may result from a lack of clinical trial awareness at hospitals and clinics that treat diverse populations,” said the authors.
“To address this gap, we commit to conduct outreach to the medical professionals in underserved communities and support trial sites with comprehensive education on medical product development.
“We will seek to further encourage the recruitment and retention of clinical trial personnel with diverse backgrounds, including racial and ethnic.”
Practices and processes
Educational efforts, particularly around health literacy, are another “key component” of reaching underrepresented groups, said the document, which recognise that the situation is not static.
Enhancing diversity in clinical trials, it said, depends on continuing to work with patients, healthcare providers, and investigators to identify and remove barriers to access and participation.
Often, barriers are baked into trials, so the principles recommend organisations take the needs of diverse populations into account at study design, and adopt enrolment and retention practices that both enhance inclusiveness and reduce participant burden.
Broadening eligibility criteria, when scientifically and clinically appropriate, can also increase enrolment diversity, they said.
In addition, participating companies will commit to sharing information on their clinical trial diversity improvement policies and practices publicly, in a bid to “promote transparency and accountability”.
Such efforts, if successful, will help build more equitable products for the future. And companies can use real-world data to enhance information on how the drugs they are marketing today affect diverse populations
Said the principles: “During the post-approval phase, collecting clinical real-world data or evidence can be an important method of supplementing trial data, in compliance with all applicable local laws and regulations.
“These data can also serve as an effective and efficient means to enhancing understanding of drug effects in diverse patient populations.”
Crucially, the industry needs to meet the needs of underserved populations who have, historically, been neglected.
By diversifying clinical trial populations, researchers will be better able to reflect the broad patient populations who will use a new medicine once it is approved. In turn, this will improve health outcomes.
“The biopharmaceutical industry commits to continuing to work with community groups, patients, patient advocacy groups, regulatory authorities, health care practitioners, academics and policymakers to define the systematic and impactful approaches that can enhance the diversity of clinical trial participants and help reduce healthcare disparities,” said the document.
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