CLINICAL DEVELOPMENT IN ONCOLOGY
increase of diversity in clinical trials so it’s great to see this long-awaited guidance. The expectation of the US population is that we are including clinically relevant individuals in the study of new products, new interventions and new devices. When I saw the guidance, I was really encouraged to see the thoughtfulness of the FDA both in the range of the requirements and the structure of the guidance which was rational and cohesive while it allows sponsors and industry to respond. We recognise that clinical trials are complex, and there are many considerations along the way. From a community perspective, however, what we are all looking for is that the industry has a good understanding of the disease being investigated – the epidemiology and prevalence of the disease and enrolling the patients that are represented by that data. As sponsors are pursuing the post-market and real-world setting, it is vital that those kinds of individuals were included in earlier clinical studies.
AB: What do you believe to be the biggest barriers as to why historically sponsors haven’t been getting more representative and diverse populations enrolled in trials and does this guidance really address those barriers?
EK: The Milken Institute released a report on this topic recently that shows we still have a challenge, one of those being distance. In trials, we still have largely academic-driven clinical trials which happen primarily in academic centres on the east and west coasts. Patients can live upwards of two hours from these clinical trial sites so that is a challenge that needs to be addressed. Another challenge is: do you have the right principal investigators? We need to train and educate the clinical research workforce in such a way that it reflects the populations that we are targeting and addressing. Individuals want to be asked by someone who looks like them, so we need to have coordinators who are in that community or community health workers or other navigators, particularly given the lack of trust. What I saw in this guidance was the FDA acknowledging that outreach needs to happen and that sponsors need to target different kinds
40 | Clinical Trials in Oncology
Esther Krofah, executive vice president for the Milken Institute
of sites and settings. What is key for that is that sponsors look at sites with a deeper lens and not just work with those sites that they’re accustomed to working with, who can enrol as quickly as possible, but they need to work with sites that are going to allow them to engage with the right patient population. Following this well-laid-out guidance, the question is going to be whether the sponsors are following this up and are building up the infrastructure to increase diversity. It’s also not just the responsibility of the sponsors, there’s a lot of work that needs to happen at the ecosystem level to get community health centres built up and able to recruit these kinds of patients that we desperately need in our trials.
AB: How far have sponsors got to go for people to feel that they can trust these companies to be involved in a clinical trial?
EK: Think about the Tuskegee trial or Henrietta Lacks. The community lacks trust so it is going to be very difficult for some people to come around. The biggest problem within the community is that we are never asked in the first place. It is not just that trust question, we need to take it and flip it on its head to say, we need to create opportunities and long-standing relationships with the community to build up that trust. It’s really going to be about the
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