Veterinary Medicine - September 2008 - (Page 485)

cerns regarding participation in clinical trials, some of which can be resolved by improving investigator and participant communication. Other concerns require that practitioners take a more altruistic approach to generating new knowledge. At least three approaches might increase patient recruitment. Ensure simple guidelines and thorough informed consent. Investigators must clarify and simplify guidelines that participants must follow so practitioners can and will take time to collect data correctly. In addition, the informed consent must be clear and complete since practitioners or their clients may also be concerned that patient health is put at risk. As little as 10 years ago, informed consent was basically a permission slip the owner signed to allow a pet to participate in a study. Today, the client informed consent describes, in lay terms, all procedures, risks (including possible placebo assignment or a description of any potential adverse events), beneﬁts that directly affect the patient, conﬁdentiality, and client costs of participating. A well-designed informed consent should also identify alternative therapies should the client choose not to participate and guarantee that choosing not to participate will not alter the level of care the pet might otherwise receive. Practitioners might approach the informed consent as an opportunity to guide clients through the decisionmaking process and present the clinical trial as a therapeutic option that is not available through other venues. However, the fully-informed client should make the ﬁnal decision regarding participation, thereby reducing practitioner risk. If a study is blinded and precludes clinician knowledge about which therapy patients receive, fail-safe procedures (described in the informed consent) should be in place that allow codes to be broken (ending the study) if patient health is at risk for any reason. Practitioners might also be concerned about the continued availability of successful therapies once the study ends. The informed consent should address means by which therapy can be continued, if desired, and the anticipated client cost of continued therapy. Consider alternative reimbursement for participation. Practitioners also are hesitant to dedicate their limited time to participation in a clinical trial. Financial reimbursement for participation is not unreasonably expected; certainly, physicians are compensated, as are practitioners participating in industrysponsored ﬁeld trials. Perhaps this is where the altruistic side of veterinary medicine might emerge: Colleges and private foundations that fund clinical trials in animals often cannot afford reimbursement for veterinary participation. Some innovative approaches to rewarding practitioners such as coauthorship (if appropriate), acknowledgments in the reports, or providing certiﬁcates of contribution suitable for display might encourage more participation. Help develop and use a recruitment database. Among the biggest obstacles to patient recruitment for veterinary clinical trials is adequate promotion of trials available to animals. Human clinical trials recruit patients through media as diverse as magazines, subway walls, and Web sites. People can search the Web for clinical trials that target their ailment. In veterinary medicine, few means exist for shared communication regarding clinical trials. Each academic clinical trial center lists its ongoing studies on its Web site, and VIN members can communicate about studies, but the net thrown out to Practitioners might approach the informed consent as an opportunity to present the clinical trial as a therapeutic option. VETERINARY MEDICINE September 2008 485

Table of Contents Feed for the Digital Edition of Veterinary Medicine - September 2008

Veterinary Medicine - September 2008 Contents Leading Off Practical Matters Idea Exchange A Challengin Case: Thymic Cyst and Recurrent Chylothorax in a Cat 10 Life-Threatening Behavior Myths CE Form Advertiser Index Marketplace/Classifieds Mind Over Miller

Veterinary Medicine - September 2008

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