Guest Column | February 16, 2021

Turning Point In U.S. History: Our Chance To Do Better With Clinical Trials

By Charlotte Jones-Burton, MD, VP of Clinical Development-Nephrology, Otsuka

Paper Ships

Over a decade ago, I made the decision to transition from being a full-time physician to designing and executing clinical trials to help develop the innovative therapies that will transform and shape the future of medicine. As I transitioned to this new role, I could not help but notice there were not many people who looked like me — a black woman. The more I became acclimated within the industry, the more heightened my awareness of the fractured healthcare system became.

We are at the beginning of important conversations. Conversations that need to happen so we can definitively address the health disparities that continue to impact outcomes among ethnic and racial groups in the United States. These conversations must be tailored to the needs of underrepresented communities who for too long have either been ignored or, at best, are an afterthought for those developing new therapies that may work differently on people from different backgrounds and ethnicities.

Because of this, our industry needs to do its part by taking the necessary measures to transform and improve the future of healthcare. To do so, it is vital that we identify and address what is broken within the system and design a plan to immediately course correct with actionable next steps and accountability. For example, the development of more inclusive clinical trials can help address disparities and help us more fully understand the impact of a new medication on diverse populations. Notably, experts agree that part of the solution should include engaging with traditionally underserved communities through a diverse working group of scientific and community advisors, investigators, and vendors that represent the populations we want to reach.

As we look toward the future of clinical trials, we must not ignore or forget past injustices. It is by recognizing structural racism and its impact on the healthcare field at large, and taking the time to acknowledge gaps and biases, that we can learn from them and in one voice say, “Never again.” Throughout U.S. history, there are countless examples of abuse, inappropriate medical care, and other blatantly racist acts that have forged mistrust and impacted the relationship between the medical community and communities of color. Historical events, such as the unethical use of Henrietta Lack’s cells for research without her consent or the horrific Tuskegee Study, have created aversions for people of color to enroll in ethical clinical trials. However, there are many clinical trials that have enrolled diverse populations, including cardiovascular outcomes trials and recent COVID-19 vaccine trials. Thus, it is important to understand best practices for inclusive clinical research and being intentional during the drug development process to form a foundation of trust between healthcare practitioners, researchers, and patients and the advocacy organizations that represent patient communities.  Importantly, leveraging leaders in the industry who are a part of the communities that we want to build trust with is critical. This is the basis for why I created the organization Women of Color in Pharma. Black and Latina women who are in the pharmaceutical industry are also leaders in their communities uniquely positioned to help bridge the divide and mistrust of the industry and healthcare system.

Demanding Diversity Among Clinical Trial Populations

Late last year, the FDA issued a final guidance titled Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, and Trial Designs. The guidance provides the “agency’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches.” Through the 21-page document, the FDA provided recommendations for how sponsors can increase enrollment of underrepresented populations in clinical trials. Importantly for our industry, the guidance also offers recommendations on how product sponsors can improve clinical trial diversity by accounting for logistical and other participant-related factors that could limit involvement.

As a step in the right direction, shortly after the FDA guidelines came out, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results to enhance racial and ethnic diversity among participants in clinical trials run by the drug makers that are members of the organization. The principles have four main areas of focus — build trust through outreach; acknowledge past wrongdoings; reduce barriers to access and monitor the effectiveness of treatments in diverse populations once on the market; and maintain transparency in efforts to increase diversity and inclusion in clinical trials.

To achieve the desired outcomes set forth by the new sets of industry guidelines, pharmaceutical and biotechnology companies, along with regulatory bodies and site sponsors, must be diligent in incorporating into their trials all the changes that will deliver a more diverse and inclusive patient population sample. These trials will produce generalizable data and allow us to truly understand the new therapy’s benefits and risks in the broadest populations possible.

Fortunately, recent technological advances have paved the way for the transformation of future clinical trials. I am fortunate to work at Otsuka, a company committed to the democratization of clinical trials and patient engagement that is leveraging the latest technology to facilitate reaching traditionally underserved and underrepresented communities, increase patient engagement, as well as raise medication adherence to improve the health of people with challenging health conditions. The in-house platform is not only used in traditional and decentralized clinical trials but also facilitates patient support programs for commercially approved products as well.

Looking Beyond The FDA Guidance: A Call For Action

As we continue to navigate the COVID-19 crisis with the evident pandemic treatment disparities that have appropriately generated worldwide attention, we must be unwavering in our commitment to address the inequities that have been so glaringly obvious during this world emergency. Only then will we have the real-world knowledge to help ensure that the medicines and devices being developed today are both safe and accessible to the broadest population. Leveraging the new protocols with advanced tools and technologies, that the pandemic helped to accelerate, will be key in breaking down the barriers that perpetuate clinical trial disparities.

I am proud to be part of an industry that recognizes that change is needed and is willing to transform itself to adjust to the needs of patient communities everywhere. But, it takes the collective. It is vital that we intentionally engage with trade and patient advocacy groups, providers, researchers, and clinical site sponsors who are uniquely positioned to reach these communities, operationalize the tenets, and most important — build trust.

The FDA and PhRMA guidance, though welcome, are not binding and should be seen for what they are: only a primer. The big challenge for people like me, who design, implement, and lead clinical trials, is accountability and documenting meaningful change so that diversity, equity, and inclusion eventually become standard operating procedure.

So now is the time to discuss next steps to ensure an inclusive selection process, rigorous reporting, total transparency, urgent design of strategies that respond to current needs, and the building of relationships that will be required to remove disparities, including relationships with community leaders and the communities themselves. A lot of work needs to be done, but when we get it right, we will finally be able to serve all patients with the appropriate treatment and services they deserve.

About The Author:

Charlotte Jones-BurtonCharlotte Jones-Burton, MD, MS, an entrepreneurial pharmaceutical executive, has brought innovation and passion to her diverse roles within the healthcare industry over the last 20+ years as clinical development leader, internal medicine and nephrology physician, academician, and change agent. In a top biopharmaceutical company, Jones-Burton leads cross-functional teams to design, implement, and oversee clinical trial studies for innovative medicines. She has also achieved a high level of success as an entrepreneur in direct sales and franchise industries. Jones-Burton excels in building and empowering diverse teams that deliver business results and has received numerous awards, including the 2020 MM+M Platinum award for Outstanding Contribution to Healthcare.