CLINICAL DEVELOPMENT IN ONCOLOGY


sponsors partnering with community-based organisations. This is not about any individual company coming and trying to resolve trust with them, it is about the industry as a whole showing that it cares about this issue of diseases that are prevalent within these communities and showing how they are going to partner with community organisations that have been there to support these communities and will continue to be there. That’s what I’m seeing and that’s the


approach that sponsors are taking. We have a lot of great examples of how these partnership models have worked really well. A great one is called Beacon of Hope, which involves several sponsors and academic institutions that are pulling their dollars together to build infrastructure at the community level. This kind of programme shows that we are going in the right direction, we just need to keep moving that way and not go back to the days in which we hovered and kept sites and trials limited to provide efficient execution of what sponsors needed for submission.


AB: Do you think that sponsors will be happy to make these contingencies like increasing the number of sites to increase the diversity in clinical trials given the financial implications attached to these?


EK: Sponsors now recognise that they need to be part of the overall solution around the broader issues of health outcomes. The most recent report from the National Academies called ‘Unequal Treatment’ showed that we have made no significant improvement with health disparities in this country in 20 years. These cost the US hundreds of billions of dollars annually, so we need to have a solution that is about the ecosystem driving toward the same goal.


AB: In the guidance, the FDA is providing a waiver for certain situations, have you any concerns that it might be used as a ‘Get Out of Jail Free’ card?


EK: What I was encouraged about was that they said these waivers will be rare and issued on a case-by-case basis, only with scientific basis or operational bases. It has been made


“What we are seeing in the data for many disease conditions, chronic disease conditions, cardiovascular cancer, diabetes and more, is that health outcomes for these underserved populations can be two to three times worse in either morbidity or mortality”


very clear from the outset that this is not just about coming forward to say it can’t be done because it’s too difficult or because it’s expensive, but rather true scientific issues or questions. While I am cautious about that, I would not say I’m worried about it. We need to make sure the early examples of how the FDA grants those waivers are proper.


AB: How vital are clinical trials to improve health equality across the US?


EK: What we are seeing in the data for many disease conditions, chronic disease conditions, cardiovascular cancer, diabetes and more, is that health outcomes for these underserved populations can be two to three times worse in either morbidity or mortality. We are now seeing in pockets of the country where life expectancy is declining. This is happening in the very communities that are left out of clinical trials and clinical research. With current innovations, sometimes access to clinical trials is considered standard of care so we are in some ways denying standard of care, by not being thoughtful and including populations that have the most prevalence of disease. It’s not just a moral obligation, it’s a scientific obligation, and a care and outcomes obligation. We must fix this. Even now in 2024 there are still trials in the US with 80% white Caucasian men – something has to change.


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