By Andy Plump, President of R&D, Takeda
May 10, 2022
Why drug developers must take the lead on creating more inclusive clinical trials
Republished with permission from BioCentury. This article originally appeared on May 4, 2022 here.
In its latest move to improve diversity among clinical trial participants, FDA issued new draft guidance on April 13 encouraging sponsors to create a diversity plan before starting trials. FDA has set the bar, but we cannot rely on regulators alone to create change. Rather, advances in clinical trial diversity need to be industry-led.
The guidance is yet another signal from FDA that underrepresentation should no longer be tolerated.
Lack of clinical trial diversity is an ethical and scientific dilemma that demands our immediate collective attention. It is our responsibility to enroll trial populations that represent the diversity of our communities, and it won’t happen by accident. Companies must take proactive steps to break the status quo.
From my conversations both within and outside Takeda, I’ve identified several areas of high prioritization for the biopharmaceutical industry to consider.
Directly engaging the participation of underrepresented communities helps us answer the pressing questions needed to design clinical trials that will provide the most benefit to the populations impacted.
These questions will help determine the needs of the community and how we can best serve patients, caregivers, doctors and others across the healthcare spectrum.
We can then implement the findings into trial design and increase accessibility for the community. This step can be done between individuals or organizations, but it is crucial to designing and implementing clinical trials that have high participation from underrepresented communities.
The R&D process is complicated. As an industry, we too often fail to adequately communicate its complexities, causing some to opt out of participation.
To improve trial enrollment, we need to clearly and simply articulate how a drug was made, how we expect it to work, potential safety concerns, and what (if any) treatment options already exist outside of the trial.
Investigative site staff should also be diverse and able to relate to the lived experiences of participants, further building trust. These steps increase transparency of clinical trial design and function, improve buy-in from the community, and help patients overcome fears related to participation.
I’ve found that overcoming language barriers is key to promoting the diversity of clinical trial populations, demonstrating respect and consideration for patients’ multilingual backgrounds and preferences, and supporting informed decisions prior to participation in clinical trials.
There are early signals that the industry is already stepping up in this area. As an example of a pharma company taking this to the next level, my company has, for the first time, enhanced our Takeda Clinical Trials website with a translation tool, making clinical trial information accessible in 34 languages and offering translation of non-study specific website details, as well as specific information on individual clinical trials.
To maximize clinical trial participation among historically marginalized and underrepresented groups, the road to discovering and implementing solutions must involve life sciences companies listening and partnering with patients. Many people from underrepresented communities have voiced concerns about barriers to access, and these should be the minimum considerations for clinical trial design.
Socioeconomic considerations extend beyond the cost of treatment — and simple and practical interventions can make big differences.
“Industry leaders should be continuously pushing ahead of and beyond government requirements.”
For example, individuals may need compensation for travel to treatment sites or meals, if treatment sessions take several hours. Accessibility to the trial site is also crucial. Ideally, sites would be located centrally within a community along public transportation routes to minimize the need for additional caregiver travel support. They should also be housed in buildings that are accessible for those with disabilities.
The industry has already responded to this need with the growing prevalence of decentralized clinical trials, which are often virtual or require fewer or no in-person visits. Telehealth is often used in decentralized trials to monitor patients and limit disruption to people’s lives.
Clinical trial diversity is only the beginning to addressing the deep healthcare inequities that extend far beyond the R&D process, and industry leaders should be continuously pushing ahead of and beyond government requirements to develop new initiatives on this front. As an industry, it is our responsibility to leverage our position to influence and drive action toward greater clinical trial diversity, equity and inclusion for all communities around the world.
Andy Plump is the president of research and development for Takeda and serves as a member of the company’s board of directors.
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