Increased participation in clinical trials leads to more accurate results and empowers patients with more treatment options. However, recruiting a diverse population of participants remains challenging. Researchers analyzed a broad sampling of patient records to gain insight and discovered that interventions to improve recruitment might have the most potential at the primary care level.
In a recently published Clinical Trials study, Jared Silberlust, a 4th-year M.D./M.P.H. candidate at the Miller School of Medicine, in collaboration with other experts at the Miller School, found that patients seen at specialty care clinics at a large academic center were significantly more likely to consent to be contacted for research than patients seen at primary care departments.
“It’s important for patients to have power over their own healthcare data so that they can choose to get involved in science research if they want to. We aimed to see if there was room for improvement on the provider-side when it came to enabling patients to participate in clinical trials,” said Silberlust, who wants to be a primary care physician.
Miller School’s Maritza Suarez, M.D., chief information officer and assistant professor of clinical medicine, served as study co-author, and Alberto J. Caban-Martinez, D.O., Ph.D., M.P.H., C.P.H., associate professor of public health sciences, served as senior author.
The practice of medical decision-making—grounded on widely accepted findings in scientific literature—directs patient care in well-functioning medical facilities. Before this study, researchers knew little about how provider characteristics, including specialty type, influenced patient involvement in clinical research.
To identify what makes a patient willing to be contacted for future clinical trials, experts of the study utilized data from PatientAtlas—an electronic medical record-relational database—from a large, culturally, and ethnically diverse academic medical center.
Researchers looked at the mandatory check-in forms of 18 years and older patients, seen between November 2016 and August 2018. The information on these forms, collected during the patients’ first clinical encounter, listed the provider’s specialty—primary or non-primary care—and denoted the type of care received.
Of 320,117 total patients, 68,543 were seen by primary care providers, and 251,594 were seen by specialists when choosing their consent preference.
Patients who were seen by specialists were much more likely to consent to be contacted for clinical trials.
Conversely, primary care patients gave consent at a significantly lower proportion than specialty patients, with 18 percent of all primary care patients and 24 percent of all specialty care patients consenting to be contacted regarding future clinical studies.
Most patients, however, prefer that their primary care physicians guide them through the medical care system. For this reason, improved primary care involvement in the patient recruitment process for clinical research participation is needed. Education regarding clinical trials at the primary care level has shown to be impactful and increase overall patient participation. Thus the task of enrolling a demographically diverse population of patients for future clinical research has the potential to be best addressed by primary care providers.
“I hope to be the kind of primary care physician who encourages patients to be intimately involved in the decisions that affect the quality of their healthcare. Our findings emphasize the need to partner with patients at a primary care level to increase involvement in the scientific research that advances medical care as a whole,” said Silberlust.
The study also showed a definite racial disparity in patient consent for clinical trial contact. Patients who were of the Caucasian race, non-Hispanic ethnicity, and in the age range of 60 to 69 years consented to be contacted at a significantly higher proportion than other groups of patients.
However, a diverse demographic of subjects in clinical trials can lead to more accurate and generalizable study results, which results in greater empowerment for patients and more satisfying practice for clinicians.
“Racial and ethnic minority participation across national clinical trials is, unfortunately, low. There remain issues of trust/mistrust, as well as perceptions of discrimination, deception, and exploitation that require work and commitment by the medical and public health community,” said Dr. Caban-Martinez.
“Our study findings shed a critical light on the potential impact primary care providers have in encouraging participation in clinical trials by racial/ethnic minority populations. I am incredibly proud of future public health doctor Jared Silberlust who bridged his training in medicine and public health by merging and analyzing big data (an informatics approach) to identify an important factor in clinical trials participation.”