Decentralized clinical trials may cost more upfront, but can have huge returns on the back end, according to speakers at Informa Connect’s Decentralized Clinical Trials meeting.
Decentralized clinical trials may cost more upfront, but can have huge returns on the back end, according to speakers at Informa Connect’s Decentralized Clinical Trials meeting. The reason is that by expanding the diversity of trial participants, sponsors are “expanding the patient funnel, making it easier to recruit patients into clinical trials,” Kim Fookes, global head, diversity and inclusion in clinical trials for Novartis, USA, said during a luncheon presentation.
Getting a handle on diversity in clinical trials can be a challenge. Novartis has about 300 trials running at any given time, and some 500 groups working on products. “Globally, approximately 2 billion people lack timely access to medicines. We need to integrate them into our R&D trials to increase access and build healthcare,” Fookes said, thus expanding participation beyond just “the elite or the lucky.”
In setting a corporate strategy to build diversity into clinical trials, Novartis needed a baseline but, Fookes said, “We couldn’t answer how well we were doing. Our data wasn’t set up for that. “We weren’t looking at epidemiology, or setting demographic goals or reporting (on demographics) other than through FDA submissions, so we needed more visibility (into diversity).”
The first step to increasing diversity, therefore, is to identify data gaps around race, ethnicity, gender or other diverse elements. Then select trial sites that can bridge those gaps.
With a dearth of community health centers participating in clinical trials, Novartis announced a 10-year commitment to increase the number of clinical investigators, especially in underserved communities. The company noted Wednesday that the first clinical trial under this partnership is set to launch at Morehouse School of Medicine.
“We’re working with 27 historically Black colleges and universities (HBCUs) around internships and fellowships, to help them learn about research in early development,” Fookes said. The benefit to Novartis will come in the increasing number of potential trial sites and also in the type of early data generated. For example, Fookes noted that enrolling diverse patients in early phase trials helps identify any genetic differences that should be incorporated into Phase II and III trials.
To increase diversity, however, community engagement is vital. “It’s important that companies don’t enter communities, take what they want and leave, but instead, stay in those communities,” she said.
Showing up isn’t enough. Organizations must first build trust. This includes listening to actual patients – not just patient advocacy leaders – and encouraging patients to participate in surveys and workshops. That lowers their perceived risks and helps patients and caregivers understand that they can contribute and use their experiences to help other people even if they aren’t willing to participate in actual clinical trials, Jen Horonjeff, founder and CEO of Savvy Cooperative, said in a subsequent panel discussion.
For example, Ricki Fairley, CEO and co-founder of TOUCH, The Black Breast Cancer Alliance, researched the language around clinical trials research and “found it was wrong. We recrafted it into a message with the right information and the right voice. (Our members) want to hear from other breasties (breast cancer patients). So we use “we” and “us” rather than “you” and “them” in messages, and develop videos showing women like us talking about how trials work.”
With mistrust of research high in Black and Brown communities, it is important to explain that each patient gets either the standard of care or the advanced therapy – not placebos – and that existing therapies were, at some point, in clinical trials. Along with speaking “in a breast cancer patient’s voice”, Fairley said that TOUCH teaches women to advocate for themselves, asking about alternative treatments and whether a clinical trial is a treatment option.
The people who are eligible for early-stage trials typically are frightened and don’t know what questions to ask. “People were living normal lives and then, with their diagnosis, were thrust into a different world,” Maimah Karmo, patient advocate and CEO of Tigerlily Foundation, USA, pointed out. “Therefore, study sponsors need to appreciate where these patients are coming from, and then help them understand who’s behind the trial, including the researcher and the clinical lead.”
Building diversity into clinical trials should start early. Before finalizing trial protocols, Novartis accesses electronic medical records to determine how altering inclusion/exclusion criteria affects the numbers of patients eligible to participate. “Minor tweaks – like changing the number of months a patient must be off medication (assuming there is no scientific reason for the determination) or extending the eligible age from 55 to 60 – can make a big difference,” Fookes said.
She advised examining disease prevalence at the country level to determine the ratio of trial participants from the most affected groups. “For example, about 30% of multiple sclerosis patients are Black. Our team (initially) didn’t know that. That resulted in gaps.” Once it understood the disease prevalence, Novartis could select trial sites best able to bridge those gaps.
To recruit patients, trial sponsors should also reevaluate their assumptions of the risks and benefits. For example, Fookes told of plans to pitch the possibility of weight loss as a positive side effect of a particular investigational drug for cardiovascular disease. That perceived benefit didn’t translate to the Black community, however. Fookes recounted one Black woman saying, “We like a little meat on our bones.” Instead, the woman advised talking about the investigational drug’s effect on outcomes and life expectancy. “That demonstrates that cultural bias still exists as we make assumptions,” Fookes said.
Access to technology is a key point for patients as well as trial sites. Currently, high-speed internet generally is lacking in rural areas, although the situation is improving. Language barriers also should be considered. Novartis now translates all of its trial materials into Spanish as a matter of course, and translates materials into other languages upon request.
In designing clinical trials to attract diverse participants, the bottom line, Karmo said, is that “diversity” means ‘variety’ and ‘equity’ means ‘fair.’” Therefore, think about how you would want to be treated, and design trials that are human-centric.
As Fookes said, “Increasing diversity is an art, and there is no one-size-fits-all solution.”
