UCSF’s Move to Make Clinical Research more Inclusive for Underrepresented Patients: The Trial Site Library

UCSF's Move to Make Clinical Research more Inclusive for Underrepresented Patients: The Trial Site Library

The University of California, San Francisco (UCSF), has designed a study based on the “Trial Library” intervention intending to facilitate greater inclusivity of participation in clinical research. The UCSF team developed, from the ground up, elements to support inclusiveness, including the linguistic, literacy, and technological needs of underrepresented populations. This ongoing study will support UCSF researchers to collect essential preliminary data before a multi-site randomized clinical trial of the Trial Library intervention.

Clinical Research Lacks Diversity

It is no surprise to anyone that there are “underrepresented” populations that don’t participate nearly enough in clinical trials. With the move toward more precision-based medicine, it becomes vital that new advanced treatments get tested against representative populations. Take the most significant American cities today, for example. The majority will be majority non-white in community, yet clinical research participation is not typically anywhere close to the actual representation of the local population. Numerous studies reveal gaps in partnership between whites, for example, and African Americans and Latinos, such as the most recent study published in Jama Oncology

The Trial Library

In cancer research, it is essential to recruit a diverse and representative population—especially when considering the number of precision-based cell-based treatments in the pipeline. The more varied the study participant pool, for example, the more generalizability of findings. With the advent of digital technologies, investigators can capitalize on novel recruitment strategies available by ubiquitous digital technologies. With the pervasiveness of the internet and online tools for medical information search, heretofore not easily accessible digital recruitment strategies help add to the investigators and sponsors’ recruitment tool kit.

This UCSF-driven study will measure the acceptability, preliminary estimates of efficacy, and feasibility of the Trial Library intervention, an internet-based cancer trial matching tool. Designed to address the linguistic and literacy needs of broader patient populations, the Trial Library website will, it is hoped, influence patient-initiated conversations with physicians about clinical trial participation. The study will be based on a non-randomized, single-arm pilot study. UCSF researchers will employ statistical analysis of quantitative survey data and qualitative analysis of interview data to assess the participant experience with the Trial Library intervention.

Comments

TrialSite News principals have many years of experience with patient recruitment challenges. One of our founders spent time helping with one of the largest patient recruitment vendors at the time in the United States, if not the world. The problems of lack of diversity in clinical research go way back and have been a persistent challenge for decades. We applaud the UCSF effort and sincerely hope that someone within the UCSF team has read our survey centering on African Americans’ perceptions of clinical trial participation in the southeast. Some of the elements uncovered in this survey have been known for decades, and unless there is a fundamental change in how health systems engage with communities and individuals, then change will continue to be exceedingly slow. Trust represents a central premise and despite pervasive online tools earning “Digital Trust” is often just as difficult in the cyber world as it is in the real world.

Lead Research/Investigators

Hala T. Borno 

Brian M. Bakke

Celia Kaplan 

Anke Hebig-Prophet 

Jessica Chao 

Yoon-Ji Kim 

Jan Yaeger

Pelin Cinar

Eric Small

Christy Boscardin 

Ralph Gonzales