Jasmine Benger, senior project manager, research services at The Center for Information and Study on Clinical Research Participation (CISCRP), made that point during an Outsourcing-Pharma webinar titled Clinical Trials in Special Patient Populations. The webinar is available on-demand.
On the webinar, Benger presented data from the 2019 CISCRP Perceptions and Insights Study, which surveyed more than 12,000 people about their attitudes to clinical trials. The survey identified some differences between women, older people and the wider population.
Notably, women and older people expressed less confidence in their ability to find the trial right for themselves and felt it was important for their doctor to know about local clinical trial opportunities. Among the over 65s, 72% of people said it is very important for their doctor to know about clinical trials in the local area, as compared to 57% of the surveyed individuals aged 34 years and under.
Those findings informed one of Benger’s recommendations for how sponsors can get more women and older people into clinical trials.
Benger said, “Doctor relationships are so important in the decision making process as a whole and so the industry needs to continually think about how we can provide tools to healthcare providers so that they can be equipped to have conversations with their patients about the possibility of clinical research participation.”
The desire to get more women and older people into clinical trials reflects evidence that the study populations in some key therapeutic areas do not reflect real-world populations.
A paper published last year found 35% of participants in HIV clinical trials are women. In the real world, 50% of people with HIV are women. The study also found women are underrepresented in hepatitis, cardiovascular and chronic kidney disease clinical trials.
Christina Brennan, VP of clinical research at The Feinstein Institutes for Medical Research, explained why that matters during the webinar.
Brennan said, “We really have to know how drugs and devices affect these different patient populations. It’s very important that they get included [in trials]. Women are different. If you take cardiovascular, for example, women show different symptoms when they present with a heart attack than men.”
The underrepresentation of women and other groups is thought to stem from a wide range of issues at the participant, investigator and sponsor levels. Mistrust of clinical research, the need to balance family responsibilities, lack of investigator resources to enroll special populations and misalignment of sponsor resources are all factors.
These issues have been discussed for decades. In 1993, the NIH Revitalization Act mandated the appropriate inclusion of minorities in all research funded by the National Institutes of Health.
However, as Annemarie Forrest, director of projects at the Clinical Trials Transformation Initiative, said on the webinar, focus on the topic is yet to translate into more representative study populations.
Forrest said, “While considerable work has been done related to improving diversity in clinical trials, I don’t think we’ve seen a commensurate improvement in diversity of our patient population.”
