In November 2020, Amgen, along with other members of the Pharmaceutical Research and Manufacturers of America (PhRMA), launched industry-wide principles on clinical trial diversity with the goal of addressing the systemic issues that deter people of different races, sexes/genders, socioeconomic circumstances, and other system-level, individual-level, and interpersonal-level barriers from participating in clinical trials.
Today, April 14, 2021, these principles take effect.
We stand with PhRMA and our industry partners in this critical, long-overdue initiative. 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) – an Amgen Employee Resource Group headed by Mike Edmonson and Tamika Jean Baptiste. In October 2020, we launched the RISE (Representation in Clinical Research) Program, led by Ponda Motsepe-Ditshego, a medical doctor by training who has been with Amgen for 10 years.
The PhRMA principles focus on four main areas: building trust and acknowledging the historic mistrust of clinical trials within Black and Brown communities, reducing barriers to clinical trial access, using real-world data to enhance information on diverse populations beyond product approval and enhancing information about diversity and inclusion in clinical trial participation.
In keeping with these, Dr. Motsepe-Ditshego and her RISE team executed by Jude Ngang, director of Diversity and Representation in Clinical Research for Amgen, and Racquel Racadio, senior manager of Diversity and Representation in Clinical Research, have developed a three-year plan based on a strategic framework that identified key focus areas to tackle. 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 will engage with external collaborators to focus on community partnerships. RISE has already developed relationships with faith-based organizations like Balm in Gilead, whose mission is to prevent diseases and improve the health status of people of African descent, and is also investigating how best to provide financial support to address issues like transportation for people in communities who can’t easily get to trial sites.
This is critical work that rests not only on the shoulders of the RISE team. Rather, this is the responsibility of all of us at Amgen, especially those of us who are involved in the discovery and development of our pipeline. To that end, RISE is partnering with groups including our Global Development Operations as well as our Clinical Development organizations, and others, to drive the change and keep progress moving at a steady pace. The extraordinary response from colleagues across the company demonstrates the urgency and our shared commitment to addressing the issue head-on. There is strong support for the direction we’re moving in. We all know it’s the right one.
What are our goals? Our primary objective is to conduct all our clinical trials in ways that are fully inclusive with equitable representation of all the patients who are afflicted with the disease we are seeking to treat. With that, our initial aim is to exceed the current industry benchmark for representative enrollment in the United States within five years in select therapeutic areas. Toward that end, we are in the process of operationalizing our short, medium and long-term strategy focusing on six key areas of work that will drive our mission and vision to understand more about how a medicine will work when we have studied it in patients who better reflect the populations which our products are most likely to benefit.
Our road ahead is guided by the data:
- Approximately 40% of Americans belong to a racial or ethnic minority group, while 78% of clinical trial participants in the United States are White.1
- Black people represent 13% of the U.S. population but only 5% of cancer clinical trial participants. Hispanic people are also similarly underrepresented in clinical trials.
- Cancer is the leading cause of death for Asian-Americans, yet this population comprises only 3% of cancer clinical trial participants.
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. Our hope is that no longer will populations of certain genders, races, ethnicities, and geographies be left underrepresented, undertreated, understudied and misdiagnosed.
We believe this data-driven effort will help us and our industry peers find the next potentially lifesaving medicine supported by data from clinical trials that is fully representative of all the patients who suffer with the disease. As Dr. Motsepe-Ditshego often says “It takes a village…” and at Amgen we are well poised to shape and lead the needed change. We also know that when we raise the health of those who have been underrepresented for far too long, we raise the health of everyone.
- Food and Drug Administration. 2015-2019 Drug Trials Snapshots: Summary Report. Five-Year Summary and Analysis of Clinical Trial Participation and Demographics. 2020 Nov.
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