Diversity and Inclusion in Clinical Trials

Stephanie Van Bebber is Senior Director, Inova Schar Cancer Institute Clinical Trials Office at Inova.

As we celebrate Clinical Trials Day this year, we recognize the extraordinary work that is done by research teams every day to ensure that future healthcare treatments and interventions are safe and effective. The date of May 20th honors James Lind, who in 1747 on that day began to conduct what is believed to be the first randomized clinical trial. On the backbone of this work, the randomized clinical trial, or RCT, has now become a robust methodology and the gold standard for clinical research. 

The RCT takes many years and hours of effort. Over the course of multiple trials, researchers ask: Is this treatment safe? Is this treatment effective? Is this treatment as good as, or better than, what we have today? A “yes” to all three of these key questions may lead to better health outcomes. Yet even when we do the hard work, we know that as the treatment enters the real world we may observe outcomes that we didn’t find in the controlled environment of the trial. This is one reason it is so important to include in our trial a group of participants that will be representative of the population who will use the treatment as part of routine care. If we look at almost any evidence on this topic, we will find that we have a long way to go to ensure that the participants in our studies represent the racial and ethnic makeup of our country. 

There are many complex reasons for our lack of inclusion and diversity in clinical trials, not the least of which are historical atrocities in this field that, rightly, have impacted the perception of research. Still, I propose that one key reason we may not be meeting the overarching goal of inclusion and diversity is that we simply are not talking about clinical research and we are not asking for participation. In order to increase inclusion and diversity, we need to normalize research as part of clinical healthcare. This means that our specialized teams of career researchers should not be the only ones talking about clinical trials. Our frontline and administrative teams and probably the most important, our patients, should be discussing them as well.

How do we begin to normalize clinical trials? Inova Schar Cancer Institute has established a robust clinical trials program for our oncology patients. A question we get often get is, “How many trials do you have open at Inova Schar?” While this is an important metric, it is unlikely to singlehandedly impact the inclusion of a diverse group of patient participants. The trials themselves need a foundation of support such that the following are met:

• Every one of our team members, regardless of position, is introduced to clinical trials as part of onboarding.
• Our clinical trials team offers introductory and ongoing research education specifically to our nursing teams and to our clinical staff.
• Physicians who work for and with us all support research. All our providers are expected to talk about clinical research to patients.
• We actively work with patient advocates such as our Patient and Family Advisory Committee to ensure that we are listening, educating and remaining patient-focused in our research program.

In oncology in particular, clinical research is not unique – it is a part of clinical care. We need to talk about research as an option for patients early and often, recognizing that it isn’t always feasible for every patient to participate. Some patients may be ineligible, and some patients may be unwilling, but we need to inform them of research as it pertains to all the options in their care plans.

It would be naive to claim that normalizing research as a treatment option will right the wrongs that have already taken place or change all mindsets. In the process of normalizing, we need to acknowledge and talk about our fears. These fears may differ depending on our role in the discussion, from the provider worrying about the potential impact of the work to the fear of the patient worrying about participation in the research, but we should absolutely not be afraid to talk. Without clinical trials and the altruistic behavior of our participants, we would not have any of the treatments we use in clinical care today. Without widely presenting this as an option, we will not only continue to fall short of inclusion and diversity goals, but we will fall short of improving health outcomes as well.