CLINICAL TRIALS: PLANNING FOR SUCCESS

摘要

Prospective, blinded, randomized trials are necessary to confirm the therapeutic efficacy of the treatments we recommend to clients on a daily basis. Practical and ethical considerations demand that health professionals have a clear idea of the true efficacy of the potentially morbid or lethal treatments that they recommend clients pursue, often at significant financial and emotional cost. However, the practicalities of funding, accruing, interpreting, and publishing trials of sufficient size and quality are a major roadblock to improving evidence-based knowledge in veterinary medicine. In the author's opinion, oncology as a specialty has a longer and more effective history of evaluating outcomes-based treatment approaches than most specialties. Much of the literature is hampered by retrospective designs and lack of randomized allocation to the treatment groups, but focus on outcome pre-dates much other literature generated in the management of chronic diseases. The cost of randomized, blinded, prospective trials is very high with few funding agencies or industry partners to share or bear the cost with veterinarians seeking to generate such knowledge. A deluge of anecdotal information is available to the pet-owning public through internet searcheswhich may contradict what evidence-based knowledge has been generated. To combat anecdotal reports and better guide therapy, it is imperative that the clinical research that is done in the effort to improve outcomes for companion animals is of sufficient quality to assist in clinical decision-making. Designing, funding, and executing quality clinical trials in veterinary medicine are huge challenges that require a great deal of prior planning to overcome. Based on the author's experience, oncology trials will be the primary focus of this discussion, but the principles can be generalized to any trial effort.