NECC1200: Equine Clinical Studies
(Multistate Research Coordinating Committee and Information Exchange Group)
NECC1200: Equine Clinical Studies
Duration: 10/01/2012 to 09/30/2017
Statement of Issues and Justification
Equine clinical research is limited by the expense of the horse as an experimental animal. Equine studies frequently involve small groups of horses, larger numbers exceeding the resources of many investigators. In addition, large epidemiological and clinical studies in horse populations are not easily performed because of logistics. Nevertheless, large studies in horses have generated valuable information, and are among the more reliable in the clinical literature. The greater power of large studies directly benefits horses by improving diagnosis and therapy.
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 a Coordinating Committee on Equine Clinical Studies, under the
guidelines of the USDA Multistate Research Activities program, we wish to facilitate and encourage collaborative equine clinical studies in the North East. We would specifically seek to address the difficulties of pooling animal resources in early phase clinical trials, and the design of later phase clinical trials involving multiple institutions and multiple states. It is hoped that multistate projects, with research objectives specific to equine diseases prevalent in the North East, and associated commercial products, would result from the committee's work.
Foster development of new methods for diagnosis and therapy of equine diseases - Creating new clinical tools is difficult for isolated stakeholders. 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 - 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 - Peer-reviewed journals generally accept the randomized, double blinded clinical trial as evidence of a drug's efficacy (1). 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.
Facilitate approval of new equine diagnostic and therapeutic tools - The USDA-APHIS Center for Veterinary Biologics and the FDA Center for Veterinary Medicine regulate the sale of new veterinary products. We wish to increase collaboration between researchers and private industry early in the development of new products, to increase the likelihood of successful federal approval.
Initiation of new multistate research projects - 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.
Educate equine industry stakeholders regarding new methods of diagnosis and therapy arising from objectives 1 through 5 - 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. Establish committee - The Coordinating Committee on Equine Clinical Studies would consist of faculty interested in sharing research resources. Membership will be primarily faculty in public institutions in the North East, but will also include collaborators in private institutions and institutions outside the North East. The committee will also communicate with, and may at length include, representatives of federal and state regulatory agencies, practitioner groups, and the equine and biotechnology industries.
2. Meet annually - Gathering of the committee on an annual basis will be invaluable in helping the committee to forge relationships, conduct business and plan activities. A regional equine continuing education conference provides a convenient setting, since practitioners, researchers, educators and industry members attend in large numbers. For example, the North Eastern Association of Equine Practitioners (NEAEP) hosts a conference which could be a site for an annual meeting of the coordinating committee.
3. Inventory existing resources and develop new resources - A key role of the committee is to make known to investigators resources which may be shared, and under what conditions. Shared resources may include faculty expertise, horses, facilities, equipment and reagents. The inventory would be made available to all committee members through a dedicated website. It will also be the role of the committee to identify areas of need and to strengthen the resource portfolio. For example, methods of experimental design and statistics adapted specifically for equine field trials may need to be developed, reviewed and made available on the website.
4. Reach out to animal biotechnology industry - The animal biotechnology industry will be an essential collaborator, both in the development of products for testing, and in providing technical assistance and sponsoring outreach programs. It is hoped that successful commercialization of new products will result from the committee's work.
5. Reach out to practicing veterinarians - Practicing veterinarians will be the predominant end-users of new information generated by the committee, some playing key roles in implementing clinical studies. It will therefore be necessary to forge relationships with veterinarians so that successful clinical studies can be carried out, and new products created which are useful in the field.
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 - Additional resources and greater sample size will increase number of grants funded and manuscripts published. This may include initiation of new multistate research projects.
- New products brought to market - Increased capacity to perform clinical trials will accelerate new product development and licensing.
- Improved animal welfare - 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 conference will facilitate outreach. 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 with chair, chair elect, and secretary elected by committee members at the first annual meeting. Secretary will be elected at subsequent meetings; the outgoing secretary will assume the role of chair-elect and the outgoing chair-elect will assume the role of chair.
(1) Simoneit C, Heuwieser W, Arlt S. Evidence-based medicine in bovine, equine and canine reproduction:
quality of current literature. Theriogenology 2011; 76:1042-1050.