A CTSA One Health Alliance (COHA) survey of clinical trial infrastructure in North American veterinary institutions

Abstract

While a necessary step toward enhancing rigor and reproducibility of veterinary clinical trials conducted on the translational spectrum includes understanding the current state of the field, no broad assessment of existing veterinary clinical trial resources has been previously conducted. Funded by a CTSA One Health Alliance (COHA) pilot award, the goal of this project was to conduct an electronic survey of North American Veterinary Colleges regarding practices in veterinary clinical trial review, approval, conduct, and support in order to identify opportunities to leverage existing resources and develop new ones to enhance the impact of veterinary and translational health research.A total of 30 institutions were invited to participate in the survey and the survey response rate was 73 %. The most common source of funding noted for veterinary clinical research was industry (33 %); however, respondents reported that only 5 % (3.7–11.0) of studies were FDA-regulated. Respondents indicated that most studies (80 %); conducted at their institution were single site studies. Study review and approval involved the IACUC either solely, or in combination with a hospital review board, at 95.5 % of institutions. Workforce training related to clinical research best practices was variable across institutions. Opportunities were identified to strengthen infrastructure through harmonization of clinical research review and approval practices. This might naturally lead to expansion of multi-site studies. Based on respondent feedback, future workforce development initiatives might center on training in the specifics of conducting FDA-sponsored research, Good Clinical Practice (GCP), clinical study budget design, grants management, adverse event reporting, study monitoring and use of electronic data capture platforms.

Best practices for recruitment in veterinary clinical trials

“…Greater awareness of veterinary clinical trials and standardization of study conduct can create opportunities for expanded and effective collaborations. According to a 2021 survey of North American veterinary schools, 80% of veterinary clinical studies were conducted at a single site ( 44 ). While multi-center studies require a larger up-front time investment, human multi-center clinical trials have demonstrated the benefits of a larger and more equitable recruitment pool, and increased study efficiency may outweigh the costs.…”

“…Dedicated clinical trial units in veterinary medicine are often small, if they exist at all. Recent survey data reported that just over half (59.1%) of the 22 responding veterinary academic institutions across the United States and Canada had a centralized veterinary clinical research unit, which employed a median of approximately 4 full time equivalent personnel ( 44 ).…”

Recommendations for Ethical Review of Veterinary Clinical Trials

“…The central review concept for multi-site studies can be useful for veterinary studies as well. Consistent with this notion, a consortium of veterinary schools has suggested that a centralized IACUC (with incorporation of VCSC concepts) could promote more efficient start-up timelines for studies conducted within participating academic institutions ( 42 ). However, for private, non-academic veterinary practices, there are limited options available.…”