Last month, leaders from Northwell Health’s Feinstein Institute for Medical Research, the US Food and Drug Administration (FDA), and Boehringer Ingelheim gathered to discuss the barriers and opportunities to increase patient diversity in clinical trials.
According to a recent report by the FDA, globally, 78.6% of clinical trial participants are white. Outside the US, this number only decreases slightly to 77.6%.
Lack of trust among minority groups is often named as the reason for a lack of participation, and while the industry has taken steps to overcome the challenge, the conversation remains ongoing.
At Northwell Health in New York, this conversation has turned outward, to the neighboring communities in which the organization serves.
“Research participants need to feel valued, that their voices are heard and that they are making a contribution to the betterment of society,” said Ram Raju, MD, senior vice president and community health investment officer at Northwell Health.
The healthcare provider’s research arm, The Feinstein Institute for Medical Research, enrolls more than 15,000 subjects per year into more than 2,100 active studies, in one of the most ethnically diverse urban areas in the world.
Raju told us participant engagement is imperative to the institute’s research, and as such, it has begun to employ a number of strategies and techniques to actively engage the community – with an emphasis on outreach to underserved minority populations.
“The important aspect of this strategy is that from the outset we are focusing on the locations and venues that will provide the best access to the people and resources we need to successfully engage, collaborate with and complete our research endeavors,” he explained.
However, most importantly, Raju said the “past injustices and the mistrust that developed in minority populations must be acknowledged.”
“Present day, we are working differently by building on a foundation of collaboration to engender trust. To ensure health equity, the benefits of research must be apparent to members of all communities. Transparency and education are imperative.”
A sordid past
The basic lack of trust in medical research among minorities stems from a “historic place of how certain studies were conducted in the name of research on some minority communities in this country that has left a stain on the medical research community,” said Raju.
Perhaps the most “infamous example” of such so-called research stems back to 1932 when the Public Health Service and the Tuskegee Institute began a study to observe the progression of untreated syphilis in rural African-American men in Alabama.
The “Tuskegee Study of Untreated Syphilis in the Negro Male” was carried out in secrecy for 40 years, “under the guise of receiving free health care from the United States government,” Raju explained.
Additional “dubious examples” have “further damaged efforts to build the trust of diverse populations,” he added.
Such scandals include the 1931 Rockefeller Institute for Medical Research experiment in which human test subjects in Puerto Rico were intentionally infected with cancer cells. Thirteen died.
“Then in 1955, there was a birth control clinical trials study conducted in San Juan, Puerto Rico where women were given excessively high dosages of progesterone without informed consent,” Raju added.
As recently as 1990, the Center for Disease Control (CDC) and Kaiser Permanente of Southern California – without informed consent – experimented with the measles vaccine on six-month-old black and Hispanic babies in Los Angeles.
Seven years later in 1997, the government-sponsored experiments in which pregnant, HIV-positive African American women were given a placebo rather than AIDS medication, Raju explained.
Apart from this sordid history, Raju said those who are interested and willing to participate in research may not have the ability to participate due to personal circumstances.
“For example, if study recruiting hours are set between 9 a.m. and 5 p.m., only people who can take time off work or who don’t need to work can afford to participate,” said Raju.
“Finally, limited access to care is another problem,” he added. “Referrals to clinical studies often come from specialty care clinics, meaning if a person doesn’t have access to specialty care, they may never be considered for a trial in the first place…and then there’s also just plain old inequality at play.”
A collaborative future?
To establish trust moving forward, Raju said collaboration will be hugely important.
“Ultimately having a good working relationship and the trust of our communities drives our ability to successfully complete our work,” he said, explaining that the institute emphasizes “partnership in research,” instead of “subjects of research.”
The institute regulatory works to educate its community about the research process and its importance. It also aims to achieve social change to improve health disparities.
“It is not enough to address ‘what is the matter’ with the populations we are studying or the clinical disease manifestation, but more importantly, identify and tackle ‘what matters to the community’ from a social and quality of life standpoint, as this will both help to define the research questions and desired outcomes,” said Raju.
“They need to be key stakeholders,” he added. “It is all about giving people a voice and making them feel as though they are valued members of the research community.”