The Texas Clinical Trials Network—an opportunity to bring cancer clinical trials to diverse settings and populations
Introduction
Adequate and representative enrollment to cancer clinical trials requires protocol activation across varied sites. The recently formed Texas Clinical Trials Network, which encompasses academic, community, and safety-net clinical centers, offers access to a broad and diverse population.
Methods
The Texas Clinical Trials Network comprises six clinical centers, including two National Cancer Institute-designated comprehensive cancer centers and two urban safety-net healthcare facilities. Participating North-Central Texas sites are lead institution UT Southwestern Medical Center and network affiliates John Peter Smith Hospital (Tarrant County safety-net) and Baylor Scott and White-Temple. Participating Southeast Texas sites are lead institution MD Anderson Cancer Center and network affiliates Lyndon B. Johnson Hospital (Harris County safety-net) and UT Medical Branch Galveston. With CPRIT-supported infrastructure and personnel, the Network provides critical review of protocols to match sites’ populations and needs, IRB reliance to expedite activation, shared strategies to enhance awareness of and enrollment to activated trials, and oversight and education to support protocol management, data collection, and other trial activities. In May 2023, the Network hosted a virtual overview. Representatives from pharmaceutical sponsors and contract research organizations were invited to attend.
Results
Among 67 invited organizations, 27 attended the May 2023 event, including 24 pharmaceutical companies and 3 contract research organizations. During the meeting discussion period, attendees’ areas of interest and points of clarification were: prioritized phase of trials, use of central IRB, consideration of non-therapeutic trials, potential use of shared contract templates, future expansion to non-covered regions of Texas, capacity for hematologic malignancy trials, availability of complex therapies (such as those requiring hospitalization) to under- and uninsured populations, time to trial activation, specific tumor-type expertise within individual Network sites, planned evaluation measures and intervals, and suggested steps for interested sponsors. As of July 2023, 14 organizations (12 pharmaceutical companies, two contract research organizations) had contacted the Network for follow-up, and seven specific clinical trials had been forwarded for possible activation.
Conclusion
The broad participation suggest a strong interest from sponsors in opening clinical trials at settings with racial, ethnic, and socioeconomic diversity. Featuring disease expertise, research experience, integrated processes, and highly diverse populations, the Clinical Trials Network of Texas offers such an opportunity.