As part of the biopharmaceutical industry’s efforts to improve health outcomes for patients in underserved communities, PhRMA member companies are identifying ways to improve clinical trial diversity and reduce barriers to participation for Black and Brown communities. As these efforts continue to take shape, our industry is developing potential best practices and key learnings that we are excited to share as part of our effort to tackle these challenges head on.
This week, the first ever industry-wide principles on clinical trial diversity took effect. Adopted by PhRMA membership in November 2020 as a new chapter in the already existing “Principles on Conduct of Clinical Trials & Communication of Clinical Trial Results,” these principles build on the industry’s commitment to earn trust and address the systemic issues that deter Black and Brown communities from participating in clinical trials, so that people who want to participate, can. These efforts can be a key part of health equity and advancing racial justice by helping address health disparities to help ensure clinical trials better reflect the people that medicines/therapeutics are intended to treat.
“We are deeply committed to creating a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials,” noted Jeremy Chadwick, Head Global Development Office in Takeda R&D and executive sponsor for Takeda’s internal clinical trial diversity working group. “We are proud to stand behind the PhRMA Clinical Trial Diversity Principles and have multiple initiatives underway that align with this framework.”
Here’s how some PhRMA member companies are working to enhance diversity in clinical trial participation, as part of the industry’s overall mission to help address health inequities in the United States:
“Diversity in clinical trials is so important to me personally, as well as to Takeda. We need to drive long-term sustainable change so that studies are conducted in a truly inclusive and equitable way. We established our internal working group to define our objectives and implement meaningful changes in how we conduct studies.
“Additionally, we established a Clinical Trial Diversity function within Clinical Operations, leveraged patient input to create study-essential documents with intended populations in mind, and created investigator training programs around the world, with a focus on medically underserved communities. We’re energized by these initial steps while recognizing there is much more work to be done within Takeda and across the industry.” -- Karen Correa, Head Global Clinical Operations and lead of Takeda’s clinical trial diversity working group.
“We are collaborating with patients, advocacy groups, regulatory agencies, health care professionals and community organizations to identify and implement solutions that will result in diverse representation while improving health equity and generating evidence to help support better patient outcomes. We aim to recruit more clinical trial investigators and external advisors from racial/ethnic minority populations to help us ensure that clinical trial participation more closely reflects the composition of the U.S. patient population.” -- Robert Baker, Vice President of Design Hub and Exploratory Medicine at Eli Lilly and Company.
“Ensuring diversity of volunteers in clinical trials is a matter of equity and good science. Pfizer is committed to reducing disparities and ensuring that the participants in our clinical trials reflect the demographics of the countries and communities in which we conduct our studies. We are taking many steps to deliver on this commitment. For example, using a data-driven approach, we are choosing investigative sites in communities that represent a diverse pool of potential participants, to make it easier for people living in the community to participate. Pfizer is also doing more to engage diverse health care providers and patient advocacy partners and build relationships with local organizations who are trusted voices and resources for patients.
“We are also making it easier for patients to find information about potential trials available to them, providing culturally-sensitive materials tailored to patients in multiple languages. Overcoming barriers and challenges to fair representation in clinical trials won’t happen overnight nor can it be achieved by a single company. There is much work to be done, but it is critical that we ensure equity in our clinical trials. It is the right thing to do for science, for public health and for patients who are waiting for the next breakthrough.” -- Rod MacKenzie, PhD, Chief Development Officer and Executive Vice President of Global Product Development at Pfizer Inc.
“Amgen stands with PhRMA and our industry partners in the critical, long-overdue initiative to increase clinical trial diversity. Taking steps to tackle this issue is not new to Amgen. Our commitment began in 2016 under the visionary leadership of ABEN (Amgen Black Employee Network). In October 2020 we launched the RISE (Representation in Clinical Research) Program. Among the steps RISE is taking are addressing how Amgen approaches its clinical trial designs, how we select our investigators and sites, and how we are engaging with external collaborators to focus on community partnerships.
“We believe that a patient-focused approach based on trust, partnership, communication, access and patient support models will make it easier for all patients to enroll in and complete our clinical trials.” -- Darryl Sleep, MD (MBBCh, FCS (SA)), Chief Medical Officer, Amgen.
Ultimately, diverse clinical trials can help support a better understanding of the medicines being studied. With the implementation of the principles on clinical trial diversity, the biopharmaceutical industry has voluntarily committed to continuing to work with patients, patient advocacy groups, regulatory authorities, health care practitioners, academics and policymakers to define the systematic and impactful approaches that can enhance the diversity of clinical trial participants and help reduce health care disparities.
Read a summary of the industry’s principles on clinical trial diversity.
Learn more about the PhRMA’s commitment and progress to improving health equities at PhRMA.org/Equity.
Dr. Freda Lewis-Hall During her 35-year career in medicine, Dr. Freda Lewis-Hall has been on the frontlines of health care as a clinician, researcher, and leader in the biopharmaceuticals and life sciences industries. An award-winning advocate for health equity and improved outcomes for all patients, she provides advice and consumer health information on national programs such as "Dr. Phil," and "The Doctors," and is a regular speaker making dozens of appearances a year at consumer and health care conferences.