Statistics and Sample Size Calculations
Clinical Trials Registries
AVMA Animal Health Studies Database
The AVMA Animal Health Studies Database (AAHSD) lists veterinary clinical studies conducted to investigate novel therapies or to collect samples or information to gain further understanding of a disease. Veterinarians can list their clinical trials on the website. Veterinarians and animal owners may search the site to find studies that might be relevant to their patient or pet, either for a particular condition or even to provide health data or a sample from a normal animal.
The U.S. Food and Drug Administration has a listing of clinical field studies that are investigating Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs) in veterinary patients. The webpage provides animal owners, veterinarians, researchers, and the public with information on clinical field studies that are being investigated for the use of ACTPs in veterinary patients. Sponsors of ACTPs that are interested in having their clinical trials listed on the FDA’s webpage can contact their FDA project manager
Good Clinical Practice (GCP) for Veterinary Clinical Trials
The CTSA One Health Alliance (COHA) has developed an online training module to introduce Veterinary Good Clinical Practices (vGCP) to veterinary researchers, research nurses/veterinary technicians, study coordinators, and other relevant stakeholders. The course covers the design, conduct, monitoring, recording, auditing, analysis, and reporting of clinical studies that involve veterinary patients (client-owned animals) as outlined in the VICH GL9 guidance document. While compliance with VICH GL9 is not mandatory, following the practices outlined in the course provides transparency regarding data collection methods, ensures humane treatment of veterinary patients, and supports integrity/reliability of data collected. The module and more information can be found at this link
Study Design and Reporting
1. Consolidated Standards of Reporting Trials [CONSORT] The website contains helpful information about abstracts, cluster designs, reporting of harms, herbal interventions, non-inferiority and equivalence studies, trials of non-pharmacologic interventions, and pragmatic trials.
- CONSORT Statement: an evidence-based, minimum set of recommendations for reporting randomized trials including a 25-item checklist and a flow diagram.
- CONSORT “Explanation and Elaboration” document: explains and illustrates the principles underlying the CONSORT Statement.
- Extensions of the CONSORT Statement: give additional guidance for randomized controlled trials (RCTs) with specific designs, data, and interventions.
2. MOOSE: Meta-analysis of Observational Studies in Epidemiology: A Proposal for Reporting. Donna F. Stroup, et al. published in J Am Med Assoc 2000; 283:2008-2012.
3. Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA]. Per the website, “PRISMA is an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses” and “focuses on the reporting of reviews evaluating randomized trials….“
4. Reporting guidElines For randomized controLled trials for livEstoCk and food safeTy [REFLECT]. Per the website, REFLECT provides “evidence-based minimum set of items for trials reporting production, health, and food-safety outcomes.“
5. STARD: The objective of the STARD initiative is to improve the accuracy and completeness of reporting studies of diagnostic accuracy, to allow readers to assess the potential for bias in the study, and to evaluate its generalisability. Several papers have been published with checklists and flow charts:
6. STrenghtening the Reporting of OBservational studies in Epidemiology [STROBE]: An international, collaborative initiative of epidemiologists, methodologists, statisticians, researchers, and journal editors involved in the conduct and dissemination of observational studies…. The website includes checklists, publications, a discussion forum, as well as other information.
7. Veterinary Oncology Clinical Trials:
Thamm DH, Vail DM. Veterinary oncology clinical trials: design and implementation. 2015. Vet J.
London CA, et al. 2009. Multi-center, placebo-controlled, double-blind, randomized study of oral Toceranib Phosphate (SU11654), a receptor tyrosine kinase inhibitor, for the treatment of dogs with recurrent (either local or distant) mast cell tumor following surgical excision. Cancer Therapy: Clinical.
Burton JH, et al. 2015. Pulse-administered Toceranib Phosphate plus Lomustine for treatment of unresectable mast cell tumors in dogs. JVIM.