By Ed Miseta, Chief Editor, Clinical Leader
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The COVID pandemic in 2020 brought to light the significant disparities that exist in healthcare. But those same disparities also exist in the way clinical trials are structured and conducted. White males are the primary participants in trials, while women, people of color, and the elderly are generally underrepresented. People of color make up 39% of the U.S. population but represent between 2% and 16% of patients in clinical trials. African Americans alone are about 12% of the U.S. population but make up just 5% of trial participants. Hispanics are about 16% of the population but only 1% of trial participants.
When Moderna faced public scrutiny for under enrolling black Americans in its COVID-19 vaccine clinical trials, the company slowed recruitment to enroll more patients of color. Most pharma companies do not face the same scrutiny. Representative trials are not a requirement of FDA approval and until recently was not a concern for the life sciences industry. However, in the last few years, diversity has suddenly become a greater priority.
The Harvard Business Review (HBR) recently published an article titled Addressing Demographic Disparities in Clinical Trials. The article outlines three recommendations for creating representative patient data. The recommendations come from interviews with dozens of leaders in the healthcare industry, including disease foundation CEOs participating in leadership forums hosted by the Harvard Business School Kraft Precision Medicine Accelerator.
Know What Representative Means For Your Disease
First, the article recommends knowing what representative means for your disease and your set of intentional recruitment goals. We know diseases affect different populations in different ways. Sickle cell disease and multiple myeloma are more prominent in people of African American descent and Hispanics, which is very different from the representative population for prostate and breast cancer. To properly set goals for the trial population, researchers must know what is representative for a disease.
Use Patient Registry Datasets As The Basis For Trials
The conduct of a clinical trial tends to be straight-forward. Patients are recruited and induced to participate, the trial is conducted, and data is sent to the FDA for approval. A tool that can be useful in the recruitment process is disease registries. The registries are managed by independent disease foundations and aggregate real-world data. They contain personal and demographic data such as race and ethnicity, which can be invaluable to researchers trying to determine a representative patient set. They also share data and insights with patients, which help to establish relationships and build trust, two things badly needed in the pharma industry.
HBR notes that by tapping these registries as a source for trial patients, researchers can define precise participation criteria and identify patient segments and sub-segments to match the criteria. This will allow them to access representative patient populations.
Go Beyond Traditional Academic Medical Centers
This is not the first time I have heard this recommendation. Others in the industry have noted that if you want to recruit minority patients you can’t sit back and wait for them to come to you. You need to go to where those patients are located. Oftentimes that means going beyond the big city healthcare facilities and academic medical centers (AMCs).
Go To Where The Patients Are
At the 2016 Society for Clinical Research Sites (SCRS) Global Solutions Summit, one speaker noted there are approximately 38,000 zip codes in the U.S. Around 70% of African Americans reside in 2,500 of them. Almost half of all Hispanics reside in 1,500 zip codes. These minority populations are served by 500 hospitals and 40,000 primary care physicians. If pharma wants to know where to find minority patients, the answer could not be clearer. More diverse patient populations can be engaged by expanding the number of sites where patients are recruited for trials.
Going to where the patients are will require pharma to think more broadly and creatively about all recruitment channels. HBR also recommends formulating a channel strategy most appropriate to your disease and patient population. In addition to AMCs, the article recommends researchers consider health systems and community networks. Health systems have access to many patients with good data about each patients’ disease state, gender, ethnicity, and more.
Community networks are grassroot networks that use creative approaches to engage and enroll patients. One example is organizations that work with thousands of churches which are trusted sources of information in communities of color.
Another source of patients is a direct-to-consumer approach, which involves going directly to patients using traditional consumer marketing and social media. “The idea is not to be limited to AMCs or to pick just one channel but to think strategically about which channels and combinations can help your organization build a large, representative registry for your disease,” notes the article. “Understand the capabilities of potential partners, the populations they can reach, their level of trust in the community, and their ability to execute.”
The importance of a diverse patient population will not wane. With the growth of precision medicine, data and diverse patient populations will continue to become more important. A representative patient population and corresponding data will be essential in ensuring no patients will be left behind in the search for cures.
Addressing Demographic Disparities in Clinical Trials was co-authored by Kathy Giusti and Richard Hamermesh, faculty cochairs of the Harvard Business School Kraft Precision Medicine Accelerator, and Mark Krasnow, founder and CEO of BullsEye Resources. The article can be viewed here.