Written by: Priscilla West, MPH
The NAVREF Industry Partner Consortium (IPC) held three meetings during the past year. An Executive Committee for the IPC was developed to help focus and prioritize the broad interests of the group. The charter members of the Executive Committee include: Peggy Bradley (Executive Director, Biomedical Research and Education Foundation of Southern Arizona), Angie Smith (Executive Director, North Florida Foundation for Research and Education), Caroline Zink (Executive Director, Baltimore Research and Education Foundation), Sean Cunningham (Janssen), Theresa Devens (Eisai), and Allyson Gage (Cohen Veterans Bioscience).
At the most recent IPC meeting in Miami on December 6-7, conversations continued about decentralized clinical trials (DCTs), and how they might best work for VA sites. Decentralized clinical trials are characterized by less dependence on traditional clinical research infrastructure, and more on virtual communication tools like telemedicine, patient-driven communication devices, home health visits (or visits at ancillary facilities closer to the patient’s home), and direct mailing of study medications and other study materials to the patient’s home. The Covid pandemic led to strong interest in developing DCT methods, and the IPC is discussing how some of these methods might improve veteran access to clinical trials and their satisfaction with the research experience.
The IPC Miami meeting also included a discussion about consistent access to VA data to provide support to NAVREF members, VA researchers and clinical trial sponsors in the following areas:
- · Identification of prospective study sites for new or expanding studies
- · Prescreening potential study subjects for existing studies
We will move forward with contracting with the VINCI program to provide these services for NAVREF members. During the first year, it will be important to establish the level and scope of demand so that we can best tailor services for future years.
Our IPC industry colleagues identified the need for a VA clinical trial ‘Playbook,’ describing the VA processes for reviewing and approving clinical research in lay terms (including a dictionary of VA research-related acronyms). A big thank you to Katrina Washburn (Executive Director of the South Florida Veterans Affairs Foundation for Research and Education), who volunteered to take the lead on drafting this document.
The Miami IPC meeting wrapped up with a discussion about how we can best support diversity and equity in VA clinical trials, including gender, race, and geographic distribution/rurality of study subjects. Industry partners noted that the US Food and Drug Administration also has strong interests in promoting equal access to clinical studies. There was unanimous support for this effort, and we will be reaching out to other government and nonprofit agencies to assist us in developing effective strategies to strengthen equity in clinical trials access and participation.