Most clinical trials are not representative of the general population or of people with a particular disease. Clinical trials primarily recruit white male patients, with a consistent under-representation of women, the elderly, and people of color, especially black and Hispanic patients. While people of color make up about 39% of the U.S. population, these groups represent 2% to 16% of patients in the trials.

This under-representation emerged as a problem during the trial of Moderna’s Covid-19 vaccine. When it was reported that black Americans made up just 7% of the trial versus 13% of the U.S. population, Moderna slowed down the trial to quickly recruit more people of color as participants.

Moderna was the exception. Companies rarely get public scrutiny, don’t need a representative trial to gain U.S. Food and Drug Administration (FDA) approval, and believe recruiting representative patients adds time and expense. The conduct of various trials has not been mandated and has not been a priority.

Yet overnight, the world changed. The pandemic has highlighted disparities in health care. Treating them quickly became a priority for the healthcare ecosystem, including the research community.

How to create representative patient data

With disparities now on the agendas of organizations searching for a cure, the challenge is how to create representative patient data and how to access and engage patients of color.

Based on interviews with dozens of leaders in the healthcare ecosystem, including CEOs of disease foundations who participate in leadership forums hosted by the Harvard Business School Kraft Precision Medicine Accelerator, we offer the following framework .

1. Know what “representative” means for your disease and set intentional recruiting goals.

Each disease affects different populations – with differences in age, sex, race and ethnicity. What is representative of sickle cell anemia, which is more common in people of African and Hispanic descent, is very different from what is representative of breast or prostate cancer.

By knowing what is representative of a disease, researchers can set intentional goals for the test population. For example, since the Multiple Myeloma Research Foundation (MMRF) learned that about 20% of patients with this disease are black, it has been working to ensure that all of its studies include a representative population.

2. Use patient registry data sets as the basis for trials.

Trials tend to be limited in scope and transactional. Patients are recruited from scratch, encouraged to participate, the trial is conducted, and then the trial ends.

Disease registries – which are often managed by independent disease foundations – are fundamentally different. Registries are longitudinal in nature, can aggregate large and in-depth real-world data, including a multitude of personal and demographic data (such as race and ethnicity), as well as clinical data, genomic information and data. biological samples. Importantly, when done right, through multiple interactions with patients over time and providing participants with added value by sharing data and ideas, registries engage patients, build relationships and build trust. .

By using robust registries as a source of patients for trials, researchers can define precise participation criteria and identify segments and sub-segments of patients that match those criteria. In this way, researchers can avoid many of the problems that hamper recruitment for clinical trials and can access representative patient populations.

3. Go beyond traditional academic medical centers (CMAs) to access patients.

The ability to recruit diverse patient populations has been limited as the source of patients in the trials has been largely confined to AMCs. More diverse patient populations can be involved by expanding where and how patients are recruited for registries and trials.

We recommend that organizations planning to conduct trials “go where the patients are”. It means thinking broadly and creatively about all possible channels for patient recruitment – both within and outside healthcare – and formulating a channel strategy that is most appropriate for your disease and patient population.

In addition to going to AMCs, we recommend that you consider the following:

Health systems. They have access to a large number of patients and usually have good data on patients’ disease status, clinical history, gender, ethnicity, etc. For example, Ochsner Health, Louisiana’s largest healthcare system, cares for around one million people, encompassing a diverse population. Ochsner is building community health centers in disadvantaged neighborhoods and has set up a clinical research arm. With a strong presence in “Cancer Alley” – the stretch along the Mississippi River between Baton Rouge and New Orleans with dozens of petrochemical plants and high cancer rates – Ochsner represents a potential partner for researchers interested in registering the various patients of this system.

Another example is a partnership between the Prostate Cancer Foundation (PCF) and the Veteran’s Administration (VA), the largest integrated healthcare system in the United States. The VA has a large number of prostate cancer patients, 40% of whom are African American, and has one of the best electronic health record (EHR) systems in the country. Used by all of IL’s 1,700 hospitals and clinics, it collects and stores consistent longitudinal data on over 23 million patients who have received IL care.

Community networks. They are grassroots networks that use creative approaches to engage and enroll patients. For example, organizations that work with thousands of churches, who are essential trusted intermediaries in underserved communities of color, can help recruit diverse patients for registries and trials.

Direct to consumer (DTC). It involves speaking directly to patients, using modern consumer marketing and social media approaches to reach and engage patients. The Follicular Lymphoma Foundation – founded by an executive from Facebook – harnessed DTP marketing and social media to build a global online follicular lymphoma community. This is the antithesis of working only through AMCs.

The idea is not to limit yourself to AMCs or choose a single channel, but to think strategically about the channels and combinations that can help your organization create a large registry representative of your disease. Understand the capacities of potential partners, the populations they can reach, their level of trust in the community, and their capacity to deliver.

Why tackling disparities matters

In the age of precision medicine, the key to accelerating healings is data. But without representative data from all patients with disease, researchers won’t be able to determine which patient segments and subsegments are most helped by treatment. Representative patient data and the information gleaned from that data is essential to ensure that no patient is left behind in efforts to cure disease.

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