Covid-19 serves as catalyst for effort to diversity clinical trial enrollment
McKesson Ventures Vice President and Partner Carrie Williams was a speaker on a panel at MedCity’s INVEST conference, April 22, 2021. She and the other panelists, Allison Kalloo, founder and president of Clinical Ambassador; Doug Langa, executive vice president of North America operations and president of Novo Nordisk, Inc.; and Cynthia verst, president, design and delivery innovation for research & development solutions at IQVIA, discussed the importance of improving clinical trial diversity and how technology can upend the old ways of clinical trials.
Kalloo said that the lack of diversity in clinical testing has been a persistent problem, noting that the FDA database’s demographic data on clinical trial participants shows that for about three-quarters of the drugs approved by the FDA, there are not enough data from minority participants to be statistically significant. “No other set of facts underscore the need for a reckoning in clinical trials than these data,” Kaloo said.
Langa said that drug companies and CROs see barriers to recruiting underrepresented groups to clinical trials. In some cases, travel time or finances make it hard to participate in clinical trials. However, he added, clinical visits can be made more accessible by being placed at sites in trusted locations.
He added that the Pharmaceutical Research and Manufacturers of America (PhRMA) recently published its first ever principles on clinical trial diversity. Those principles include building trust, reducing barriers to access, using real-world data, and sharing successes and failures.
McKesson Ventures’ Carrie Williams said that some aspects of a study could be done in the community, at locations such as pharmacies or imaging centers, or even at home. She noted that telemedicine allows providers to consult with patients remotely and that electronic consent permits patients to review clinical trial documents from anywhere. However, she said, it’s important not to lose sight of the human element of testing. Some patients may actually prefer in-person settings.
Clinical trial capabilities were already expanding into the home before the pandemic, but the pandemic did accelerate the adoption of technologies that are making decentralized clinical trials possible.
Ultimately, Kalloo said, transparency is key to building trust. IF patients can offer feedback on their clinical trial experiences, “it would help to keep the industry open, honest, and transparent.”
Read the full article here.