Design of clinical trials for new drugs in animals.
Consideration of the intended purpose, an effort to ask specific questions that can be answered by specific data, selection of the correct values to be measured, and investigators who are able to conduct the study, will make it possible to design clinical studies properly. The ethical need to avoid unnecessary suffering of experimental animals and rules and regulations in effect at the time of clinical trials will dictate certain aspects of the design. The type of product to be evaluated, its mode of administration, the type of animal in which the drug will be used, the type of investigator who will collect the data, and the individual who will use the drug, will determine the mechanical part of the protocol. All of these factors need to be considered and discussed with all participants, which may include biostatisticians, regulatory authorities, investigators, and other individuals, to ensure that a rational design is chosen.
D000818:Animals; D002986:Clinical Trials as Topic / Q000662:veterinary*; D014481:United States; D014486:United States Food and Drug Administration