There’s one query that Hollings Cancer Center researcher Jennifer Dahne, Ph.D., co-director of the distant and virtual trials program on the South Carolina Clinical & Translational Research Institute, hears greater than some other as she consults with clinical researchers about methods to arrange distant trials, also generally known as decentralized trials. Will these trials overcome the barriers that make it difficult for minority and underserved populations to take part in clinical trials? It is also an issue she often discusses along with her peers at other academic medical centers which can be also home to Clinical and Translational Science Award hubs.

Dahne thinks it’s too soon to offer a definitive answer to that query. She argues in a recent Journal of the American Medical Association Viewpoint article and in the next Q&A that rigorous evidence is lacking as to how these trials affect the variety of clinical trial enrollment.

Q: Are you able to describe what a decentralized trial is?

A: Decentralized trials bring clinical research opportunities to participants where they’re relatively than bringing participants to clinical trial sites, as in the standard model. This approach goals to enhance access to clinical trials and to make it easier for patients to take part in them.

Q: What excites you most a couple of decentralized approach to trials?

A: Like many others, I think this approach has promise for making our trials more accessible to populations of patients or research participants who typically would not participate. We all know that there are disparities between who enrolls in our clinical trials and who’s burdened by the diseases that we study. The potential to make our trials more accessible, and by extension improve the generalizability of our results, is the thing that actually excites me probably the most.

Q: What advice would you give to researchers wanting to make decentralized trials the cornerstone of their clinical trial diversity initiatives?

A: We assume that pivoting to decentralized trials will increase access to clinical research for minority and underserved populations, but we want to take a critical take a look at the methods and procedures of those trials and see in the event that they are having the specified effect.

Although these trials may overcome geographic barriers, they could include their very own unique barriers.

For instance, Black and Hispanic people have considerably lower rates of home broadband web access than White people within the U.S., and there’s also a transparent association between annual household income and residential broadband web. Likewise, only 61% of adults 65 and older own smartphones as in comparison with 95% of those between the ages of 30 and 49, perhaps making it tougher for them to take part in these trials. Older adults may additionally have dexterity or perceptual issues, reminiscent of vision or hearing impairment. Those is also major barriers to participating in trials that require regular use of technology.

It is usually possible that this kind of trial design could worsen other known barriers to participating in clinical research, reminiscent of mistrust of educational institutions and of clinical research. What’s the impact of a shift to those methods on trusting academic research? With less direct contact between participants and researchers, would clinical researchers have fewer opportunities to dispel that mistrust? And the way does that differ across various patient populations? We just do not know yet.

We have learned in lots of other areas of drugs how costly it may be to roll back interventions after we realize they aren’t having the intended effect. Now that the COVID-19 pandemic is waning, now we have the chance to be very thoughtful about how we move forward with distant trials to avoid such a costly mistake – one which cannot easily be undone.

Q: How can we get definitive answers?

A: We want rigorous randomized controlled trials that compare traditional in-person clinical trial methods to decentralized trial methods. It can be essential to guage the impact of those several types of clinical trial methods on trial enrollment across various patient demographic groups in addition to on other points of the clinical trial pipeline. What’s the pace of enrollment? What about the fee of the study? What concerning the validity of the info that is collected? It can be essential to have these rigorous randomized controlled trials to reply questions on the impact of this latest approach across every step of the clinical trial pipeline.
The National Center for Advancing Translational Science recently issued a request for information to get input on critical issues around decentralized trials. My hope is that there might be increased interest and a push, particularly from funding agencies, to reply these types of questions.

Source:

Medical University of South Carolina

Journal reference:

Dahne, J., & Hawk, L. W., Jr. (2023). Health Equity and Decentralized Trials. JAMA. doi.org/10.1001/jama.2023.6982.