While the topic of clinical trial diversity has been in circulation for some time, it has recently gained traction with the US Food and Drug Administration (FDA) releasing a guidance shepherding sponsors on the implementation of diversity plans.
The FDA’s call to action is meant to improve community trust in clinical trials by considering factors such as site location and community based care that could improve data quality and applicability across diverse patient populations. In a 2023 US Food and Drug Administration (FDA) drug trials snapshots summary assessing demographic representation in clinical trials for the 55 drugs approved in 2023, the Center for Drug Evaluation and Research (CDER) noted the skewed population enrolling in clinical trials.
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Clinical Trials Arena sat down with Executive Director, Therapeutic Strategy Lead for Oncology and Hematology at the contract research organisation (CRO) Worldwide Clinical Trials, Jim Eamma to discuss how CROs and sponsors need to handle diversity plans while advancing drug development.
Justine Ra: What concerns related to clinical trials remain to be addressed to tackle diversity?
Jim Eamma: The development of new molecular targets demands the evaluation of treatments on a demographic level. We know that different cultures and races of people have different comparative biochemistries; and the distinctions can result in varying treatment responses across these populations. Truly comprehensive drug safety profiles hinge on more inclusive study populations.
However, the challenge is supplying clinical trials with those diverse populations because patients are hesitant to be clinical trial “guinea pigs”. Patients do not necessarily understand how regulated clinical research is—the steps that must be taken, the rules around patient ethics, and the approvals that must obtained before a drug can be given to a patient—as this information is often lost in translation. So, the main struggle is bridging the gap between the clinical research community and the general public to reverse the mistrust patients have in clinical trials.
JR: Now that there is a clear guideline from the FDA about how sponsors should implement diversity plans, is there anything that will change for you as a CRO?
JE: The biggest thing changing for CROs is that diversity teams will be more integral than ever. Three to four years ago, Worldwide did not have a diversity team. Now and for the foreseeable future, diversity will be included in every single operational strategy that we [Worldwide] have, especially in Phase IIb and Phase III studies.
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By GlobalDataAt Worldwide, the question constantly asked by sponsors is, “what is your diversity strategy?” So when we get these larger studies, our job is to reach out to centres that have access to different patient populations and ethnicities, so that sponsors in turn can demonstrate data with strong demographic equity. But one obstacle we face is that there are many centres with access to diverse patient populations, but they do not have research programs and consequently, have no experience in clinical research. As of now, I do not necessarily know how you begin tackling that challenge. However, this could look like establishing clinical research programs and determining if the site has the infrastructure, staff, and experience to be a workable site.
JR: Are there cases where sponsors and CROs are misaligned?
JE: The misalignment is always in the conversation of sites versus time. Sponsors will request a recruitment strategy of enrolling a certain number of patients over a given period of time; and we [Worldwide] will show them data indicating that either sites or time must be increased to achieve target enrollment.
There is really no misalignment in terms of diversity, as sponsors lean heavily on CROs to implement diversity action plans. However, there is no CRO out there that has years’ worth of data about how these diversity strategies work because everyone is just starting to employ these strategies. So while there are many strategies employed by many CROs in a competitive landscape, sponsors and CROs unanimously agree that these diversity strategies are necessary and work towards implementing these plans.
JR: With sites and time being the topic of contention between CROs and sponsors, do any of these FDA initiatives and projects help mitigate or simplify those conflicts?
JE: No, unfortunately, they do not. However, the purpose of these initiatives is to address concerns that are significant and integral to patient quality of life, which makes them a necessity. While the new frameworks call on sponsors to spend more money in the short term, if the focus is truly the patient, then the sponsors will spend more money to accomplish that goal. At the end of the day, if the patient gets the benefits and they are able to take safer drugs that have clinical durable benefits and allow for good quality of life, what ends up happening is that patients begin to trust you and stay on your drug longer. And from a financial perspective, the longer the patient stays on your drug, the more money you will make. It is a “short term pain versus a long-term gain.”
JR: In the FDA AdCom meeting prior to Eli Lilly’s approval of Kisunla (donanemab) for Alzheimer’s disease, panelists flagged the lack of patient representation—ethnic, genetically predisposed, and genotypic homozygous apolipoprotein E4 (ApoE4)—in the enrolled population. How has the term “diversity” evolved?
JE: Diversity has many layers and is not limited to race, culture, and ethnicity; especially in an indication like Alzheimer’s where we need racial inclusion as well as representation of patients with Down syndrome or those who are twins. However, there is a legitimate risk for “paralysis by analysis,” in which we will twist ourselves up into a moral, ethical, diversity pretzel. What we do not want is over-regulation that will handcuff the industry to where we grind everything down to a slow halt. It already takes a long time to get a product to market. If we begin adding too many layers to diversity, there will be people who will miss the opportunity to receive a potentially life-saving drug.
It is understandable to want to evaluate diverse subsets and diversity is critical. But if we progress diversity simply for the sake of progress and lose sight of the balance between time and quality by evaluating subsets of subsets, it is no longer a good balance.
JR: Are there instances where these initiatives would result in a net negative impact?
JE: While any negative impact is very indication specific, the FDA also recognises the limits of some indications and is flexible when it comes to representation ratios and numbers.
Specifically for cancer, no one has posed a question to us about representing diverse genotypes in patient populations; and I almost hope we don’t get there. Ultimately, it is a balance between time, money, and quality where you must ask yourself how much time and money you want to spend to only marginally improve quality.
What we are doing with diversity right now will increase trust in the general public. But breaking down populations into subsets of subsets is unlikely to significantly improve that trust.
