Improving Diversity in Our Clinical Trials for Long-term Health Equity

Across the healthcare industry work is taking place to address health disparities. The Healthcare Leadership Council (HLC) has delved specifically into social determinants of health, broadband access, disparities in care delivery, vaccine acceptance, behavioral health, and workforce and clinical trial diversity. Amgen, an HLC member, is a leader in improving clinical trial diversity as a means to ensure better outcomes for those of diverse racial and ethnic backgrounds. This recent post below lays out the company’s comprehensive strategy, strengthened by collaboration, to address systemic issues which affect participation in research.

Improving Diversity in Our Clinical Trials for Long-term Health Equity

Darryl Sleep, Amgen’s senior vice president and Global Medical and Chief Medical Officer

Last April, Amgen stood with PhRMA as the first-ever industry-wide Principles on Clinical Trials Diversity officially took effect. The goals of these Principles are to expand participation among diverse patient populations by increasing understanding and awareness about clinical trials and improving access. Since then, we’ve already seen two very significant positive outcomes. First, improving diversity and representation in clinical trials has evolved from a niche issue into a core industry commitment. Second is the development of enthusiastic, industry-wide initiatives to improve how sponsors approach and improve diversity and representation in clinical trials. We are sharing best practices and de-identified aggregated clinical trial data to continue advancing this work via our cross-industry collaborations and partnerships. In this purpose, there is no holding back; we are all dedicated to making long-overdue changes that will result in diversity and representation in clinical trials becoming a reality and not just an ideal.

Clinical trials are a critical part of the long and careful process of developing new medicines. This research is complex and multidisciplinary and there isn’t a single accelerator that can be used to address the systemic issues that deter people from participating. Instead, we need a range of different levers to update decades-old processes and create new best practices.

I want to use the one-year anniversary of the PhRMA Principles to share some highlights about the data-driven efforts we’ve taken at Amgen to lead the way in breaking down barriers and help us find new medicines supported by clinical trials that are representative of all patients who suffer from serious illnesses.

We have a dedicated team
While the push for more diversity and inclusion in clinical trials is not new to Amgen, we accelerated our efforts in 2020 with the formation of RISE (Representation in ClInical ReSEarch), a team dedicated to addressing the systemic issues that deter people from participating in research, especially those who have been historically excluded due to race, ethnicity, sex, age, and other factors. We have significant momentum with our goals as programs and teams across Amgen, including RISE, Global Medical, Advocacy, Compliance, and Global Development, trial execution and data & analytics teams work together to create greater equity through diversity and proportional representation in clinical trials.

Ongoing learning to gain understanding and insights
Communication and information-sharing are fundamental to driving change. The output from our Health Equity Summit: Disrupting Health Disparities through Partnership and multiple Community Advisory Boards focused on direct insights from Black, Indigenous and People of Color (BIPOC) which provided information on barriers, strategies, and tactics that can apply across communities. We are using these insights to directly inform the design and implementation of a long-term, study-agnostic community engagement plan – a critical step in building sustainable, trusted relationships. Additionally, our patient-focused advisory councils with representation of racial and ethnic minorities will inform our clinical trial design and execution.

Building foundational capabilities
Logistical and financial barriers, gaps in awareness, and lack of trust all impact participation in clinical trials. We are partnering with organizations and diverse suppliers to thoughtfully build our enrollment support capabilities, including providing transportation, and other potential support capabilities, as well as finding optimal ways to support staff at clinical trial sites. Taking a holistic approach to tackling these industry-wide issues will help us move the needle.

New partnerships and collaborations
Collaborative partnerships play a significant role in advancing understanding of the science and our ability to positively engage patient communities in clinical trials. Toward that end, we are engaged in a number of efforts including:

• A pilot program of the American Cancer Society Cancer Action Network to test a trial eligibility screening intervention intended to increase and diversify patient enrollment in cancer clinical trials, including navigators to help patients address logistical and financial challenges to enrolling and completing those clinical trials.
• The CEO Roundtable on Cancer’s Going for Gold initiative, in partnership with Historically Black Colleges and Universities (HBCUs) and Hispanic Serving Institutions (HSIs), that focuses on equitable cancer care.
• A collaboration with The Digital Medicine Society (DiMe) to drive inclusion in digital clinical trials by providing the tools and framework necessary to successfully engage underrepresented populations during the planning process for clinical trials that include a technology device for participation.
• Creation of the HBCU BioTech Fellowship program, a professional development program that will prepare and empower 50 students (and soon-to-be graduates) from Historically Black Colleges and Universities for careers at Amgen.

Measuring progress in our own trials
We have undertaken important steps including a baseline study that will help us measure progress for trials currently underway as well as for new trials on the horizon. Additionally, we have a number of tools in development to help us measure and evaluate best practices for improvement in enrollment of participants from diverse racial and ethnic backgrounds.

Recognizing differences in disease incidence, exposure and response to medicines
We have long been committed to unlocking the potential of biology for all patients suffering from serious illnesses using advanced human genetics to unravel the complexities of disease. Accordingly, we are using data on human diversity in our own labs and with research partners. Together, we will better understand incidence of obesity, cardiovascular disease from risk factors such as elevated Lp(a), inflammatory diseases such as atopic dermatitis and lupus, and multiple cancers in diverse populations.

In addition, we are seeking to understand and actively address the social determinants of health (SDOH) that contribute to wide health disparities and inequities that impact disease burden and access to healthcare.

Reaching the finish line will allow us to get new medicines faster to patients who need them. It will also help doctors assure their patients that the medication they’re being prescribed was studied in people like them, with results that indicate they are likely to benefit. We’re not there yet, but we’re taking informed steps with care, with the scientific expertise for which we are known, and with humility. Every day, we dedicate ourselves to serving patients by transforming the promise of science and biotechnology into therapies that have the power to restore health and save lives. As we work to fulfill our own values and PhRMA’s Principles, we’ll get closer to serving all patients, beginning with clinical trials that include people of all races and ethnicities who will benefit.

For more information, please visit Clinical Trial Diversity & Representation.