The message was from Quest Diagnostics for their Quest Clinical Trials Connect, an online portal that connects patients and physicians to clinical trial sponsors and clinical research organizations.
This was the second time in several weeks that I had received this type of solicitation by email. The first time, I hit delete. This time, I stopped to ask myself why I was so quick to dismiss this call to action.
Clinical trials have been running for hundreds of years and have become such a major part of human existence that in 2005, our calendars gained a worldwide holiday known as “Clinical Trials Day”.
But recruitment is one of the greatest challenges of clinical trials. Only about 5% of Americans have ever participated in a clinical trial. About 19% of trials are terminated due to lack of patient participation, according to a 2011 analysis, and 80% of trials do not meet enrollment standards and timelines.
Improving clinical trial diversity — as determined by age, gender, ethnicity, race and socioeconomic status — has become a major initiative to improve health equity and has added yet another layer of complexity to clinical trial recruitment.
In clinical trials for new drugs approved in 2020, 54% of participants were in the U.S., according to data from the Federal Drug Administration, with 30% age 65 and older, 56% females, 75% whites, 8% African Americans, 6% Asians and 11% Hispanics.
“The lack of diversity has always been known,” said Dr. Harsha Rajasimha, founder, and executive chairman of IndoUSrare. “It is not easy to change and the will to change wasn’t there either.”
But with growing awareness, there is more funding and research for tools and technologies that will help fill diversity gaps in clinical testing. “It will take several years or decades before we see measurable improvements, but it looks like we are heading in the right direction,” he said.
From 1999 to 2019, 25% of clinical trials took place in the U.S., according to the World Health Organization. Rajasimha is also founder and CEO of Jeeva Informatics which uses technology to make trials more universally accessible, connecting patients, specifically those in the Indian diaspora, to clinical trials in the U.S. Telehealth and remote patient engagement can help bring these global populations into the patient pool for clinical trials, he said.
It is important to identify the barriers to participation for any underrepresented population at every step of the process and address them, he said.
Medical mistrust, language barriers and lack of cultural competency among health evaluators are just some of the reasons why certain groups may be less inclined to participate in clinical research.
I thought about the reasons I am leery of joining a clinical trial.
In childbirth, I labored just over 12 hours before reluctantly asking for an epidural. If I have a headache, I reach for a pressure point instead of a painkiller. Part of my resistance to clinical trials is rooted in this “no medicine is the best medicine” approach to pain. But I realize this rationale makes no sense.
While I may avoid routine and relatively safe pain medications like ibuprofen or the medically administered drugs in an epidural, I take all recommended vaccines without hesitation. Why am I not concerned about the potential impact of those drugs even knowing that people with similar health and lifestyle factors may be underrepresented in the testing that brought those drugs to market?
I want to be part of the solution, but I had no clue what my entry point to clinical research might be until I talked to Karen Owens.
Owens, 57, lives in DeKalb County and recently began taking part in the Emory Brain Health Study. She worked at Emory University for years and her husband is a current employee. They are patients of Emory Healthcare so when they received an email from the brain center to participate in the study, there was already a level of trust, she said.
The study includes cognitive tests, an MRI and a spinal tap every two years. That gave Owens pause. The lumbar puncture comes with risks and she didn’t want to create problems for herself from any complications.
Owens, who is Black, forgot about the trial until a member of her book club, who is not Black, said she and her husband were involved in the study and had been informed that her husband had some cognitive challenges.
“I said I am going to do it,” Owens said. “We should be represented in studies and treatment and medicines so we can be as healthy as anyone else.”
Owens and her husband are both in the study. She has an MRI this week. She’s anxious but tells herself she is doing something good for the world, for her health and for the health of other African Americans.
Maybe starting with an observational study like the one Owens and her husband are part of at Emory, is a way around my personal barrier.
I haven’t made up my mind yet, but I also haven’t deleted the email. That’s a start.
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