NECC1700: Equine Clinical Studies
(Multistate Research Coordinating Committee and Information Exchange Group)
NECC1700: Equine Clinical Studies
Duration: 10/01/2017 to 09/30/2022
Statement of Issues and Justification
The North Eastern United States is home to a strong equine industry, supported by equine research programs in veterinary colleges, and the animal and/or veterinary science departments of public universities. Increased collaboration and pooling of resources between basic scientists, teaching hospital clinicians, private industry, practicing veterinarians and their clients could be used to strengthen equine research by making possible larger clinical studies. In addition, it could assist product development by the animal biotechnology sector. However, such collaborative studies pose significant logistical and scientific difficulties.
Through the formation of the original Coordinating Committee on Equine Clinical Studies, under the guidelines of the USDA Multistate Research Activities program, we have begun to facilitate and encourage collaborative equine clinical studies in the North East. We have addressed pooling of resources through compilation of an asset inventory (attached). In addition we have developed research and outreach priorities to address equine wellness and disease (see attached logic model). In the near term we have identified gastrointestinal health and the equine microbiome as areas of interest. In addition, through a survey of horse owners in the North East, we have documented stakeholder interest in further pursuit of this line of work (see attached reprint (1)). In 2016 we submitted a conference grant through the 2016 USDA/AFRI program (Causey R, Biddle A, Williams C, Burk A. Making Clinical Sense of the Equine Microbiome. US Dept of Agriculture 2016. $49,050). Although this application was not successful, a grant by a member of NECC1200 (Amy Biddle PI, University of Delaware) for expansion of her equine microbiome project has been submitted to the Morris Animal Foundation and is currently pending.
We would like to continue the work of the equine clinical studies coordinating committee through pursuing multi-state activities related to the equine health, including the equine microbiome, hopefully leading to improved quality of life for horses in the North East.
Foster development of new methods for diagnosis and therapy of equine diseases, and for improving equine gastrointestinal health.
Comments: Creating new tools to improve equine health is difficult for isolated industry sectors - practitioners understand the need, basic researchers the technology, and industry the commercialization. Greater collaboration of these sectors could improve success in subsequent clinical trials. We therefore wish to encourage discussion between these groups early in the study design process.
Improve sample size in early phase equine clinical trials.
Comments: For academic researchers, early trials in vivo would provide raw material for peer-reviewed publication. Pooling resources (such as horses) between institutions can improve statistical power, strengthening grants and manuscripts. We therefore wish to improve collaboration during these early phase trials, and make generally available the statistical methods necessary to analyze data in trials replicated in multiple sites.
Increase number and power of randomized, double blinded equine clinical trials.
Comments: Peer-reviewed journals generally accept the randomized, double blinded clinical trial as evidence of a drug's efficacy (2). Epidemiological rigor is also expected in validation of diagnostic tests, and identification of disease risk-factors. To encourage such studies, we wish to improve collaboration between researchers, practicing veterinarians, farms and private industry. The goal would be to allow field trials to be replicated in multiple sites and across state lines.
Development of a multistate research project.
Comments: The committee's activities will encourage discussion between members who share a common goal of improving equine health. We intend that the committee will generate at least one multistate research project, with objectives specific to equine diseases prevalent in the North East. A goal currently is to develop a multistate project related to equine gastrointestinal health and the microbiome.
Educate equine industry stakeholders regarding new methods of diagnosis and therapy arising from objectives 1 through 4.
Comments: To have impact, new discoveries and techniques need to be disseminated. We therefore wish to make available to all stakeholders, including veterinarians, horse owners, allied industry, state government etc, any new information generated by the committee's work.
Procedures and Activities
1. Continue committee, starting with current composition - The Coordinating Committee on Equine Clinical Studies currently consists of faculty interested in sharing research resources. Membership includes faculty in public institutions in the North East, but also collaborators in private institutions and institutions outside the North East. The committee may include a representive from the equine feed or biotechnology industries.
2. Meet annually - Gathering of the committee on an annual basis has been invaluable in helping the committee to forge and maintain relationships and plan activities. The meeting site will continue to rotate through sites in the North East US, usually hosted by members of the committee at their home institutions.
3. Develop Research Capacity - The inventory of shared resources will be updated to reflect our new membership. Increased research capacity will be sought through equipment grants, pooling animal numbers, and shared use of other resources.
4. Reach out to animal feed, supplements, and biotechnology industry partners - The animal feed, supplements, and biotechnology industry may be valuable collaborators in the development of new products, providing technical assistance, and in sponsoring outreach programs. It is hoped that commercialization of new products will result from the committee's work. This may include improved pre or pro-biotics, feeds, and supplements targeted to improve equine gastrointestinal health.
5. Reach out to practicing veterinarians - Practicing veterinarians will be end-users of new information generated by the committee, some playing roles in implementing clinical studies. It will therefore be valuable to forge relationships with veterinarians so that clinical trials can be conducted, and new products created.
6. Conduct regional outreach programs for all stakeholders - Coordinated outreach will be necessary to deliver new information to regional stakeholders (veterinarians, horse owners, animal feed and biotechnology industry, state government etc).
Expected Outcomes and Impacts
- Increased output of participating investigators and investigator-private industry partnerships. Comments: Additional resources, and new public-private research partnerships, could increase number of grants funded and manuscripts published.
- New animal health products brought to market Comments: Increased capacity to perform clinical trials will accelerate new product development and licensing. This may include new feeds, feed supplements, pharmaceuticals, and diagnostic assays.
- Improved animal welfare Comments: The greater power of clinical studies will improve diagnosis and therapy, and decrease incidence of equine disease.
Projected ParticipationView Appendix E: Participation
The coordinating committee will have a dedicated webpage, including profiles of participating members, inventory of resources available for pooling, plans for upcoming meetings etc. The annual meeting will include brief presentations by members of their work, with an annual report of the committee's activities. Nature and scope of outreach programs to stakeholders will be determined as part of the committee's initial deliberations. Because they are so dispersed, practicing veterinarians and lay groups can be difficult to access. Combining the annual meeting of the committee with a veterinary continuing education or equine industry conference may facilitate outreach on occasion. Additional methods to reach lay stakeholders groups will include non-technical bulletins distributed in print and online, targeted emails and the dedicated webpage. The use of video-conferencing and distance education technology may also be employed to solve specific needs of underserved stakeholders.
Governance will be standard.
(1). Coffin D, Causey R, Staniar B, Williams C, McKeever K, Gradil C, Nadeau J, Sanchez A, Lichtenwalner A, Biddle A, Assessing Research and Education Needs to Improve Equine Gastrointestinal Health. Journal of the NACAA 2017; 10(1)
(2). Simoneit C, Heuwieser W, Arlt S. Evidence-based medicine in bovine, equine and canine reproduction:
quality of current literature. Theriogenology 2011; 76:1042-1050.