MYONEX INSIGHTS

The right sourcing strategies can support diversity and inclusion in clinical trials

A lot of people are talking about diversity, equity, and inclusion—in general, in healthcare, and by extension, in clinical trials. Different companies in the clinical trial industry have set DEI goals and launched a variety of different programs to achieve them. If you want to increase diversity and inclusion in your studies, don’t overlook the role of your clinical trial drug sourcing and supply strategy.

Why cast a wider net?
Including participants of different ages, genders, and racial, cultural and ethnic backgrounds is a win-win. We know that different people may experience the same condition differently, and that medications can behave differently in different populations. Geriatrics is one good example. Diverse trial participation gives sponsors better insight into how the new drug product is likely to perform in a wider range of patients in the “real world.” Ultimately, that’s good for all patients and for the setup of your clinical trial. Including diverse groups in clinical trials also increases access to cutting-edge treatments for groups that traditionally have been underserved.

Recognizing the value of including diverse populations in clinical research, both the US Food and Drug Administration (FDA) and the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) have issued multiple guidance documents on the subject. Earlier this year, the FDA issued new draft guidance on enrolling more participants from underrepresented racial and ethnic minorities in the United States into clinical trials. In a press release, FDA Commissioner Robert M. Califf, MD, said, “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”

What are the obstacles?
Moving toward more diverse study participation isn’t without its challenges. For one, many people of color mistrust the healthcare system, either due to their own experiences or historical injustices such as the Tuskegee syphilis experiments. A Pew Research study in late 2020 found that only 42% of Black Americans planned to get the COVID-19 vaccine even though 71% said they knew someone who had been hospitalized or died of the disease. So building trust system wide will be critical.

Another key area we need to address is access. Not everyone lives near the large healthcare centers and research hospitals where most studies take place, nor do they have the means to travel to these sites throughout the trial. The good news is, the pandemic seems to have accelerated adoption of decentralized clinical trials (DCTs), which can reduce the visit burden on the participant.

Next steps
Change needs to start early in the drug development process. From age and gender to geographic ancestry and psychosocial stress, many factors affect treatment response and health outcomes. The National Institute on Minority Health and Health Disparities suggests that “Clinicians and researchers should carefully consider the inclusion or exclusion criteria for their clinical trials” lest they inadvertently exclude groups who might stand to benefit from their findings.

Also, consider trial design. A decentralized trial can make trial participation an option for patients who live in far-flung geographic areas. When a DCT isn’t appropriate, a hybrid trial may reduce the number of required on-site visits and make participation possible for a greater number of people. It is possible to give patients local access to drugs and supplies, including specialty and limited-distribution drugs, in compliance with local regulations in North America and the European Union. Through the CTRx North America program, drugs and supplies can be obtained locally through a broad pharmacy and specialty pharmacy network, or shipped directly to the patient. Built on the successful North American program, the CTRx Europe central on-demand sourcing network—the first and only solution of its kind on the continent—can ship directly to patients, to sites or central nursing centers, or to home healthcare professionals. Supplies—including wearables that send study data remotely—can be supplied through the same program.

If you’re looking for ways to increase diversity, equity and inclusion in your clinical trials, talk to Myonex early in the drug development process. You can contact us below, or email our team at [email protected].