Schmidt R
Int J Clin Pharmacol Ther Toxicol. 1985 Mar;23(3):158-60.
A well-designed protocol is an essential part of any clinical trial. In a drug trial it should be the result of a joint effort involving the physician performing the trial at the clinic and the specialist in the drug company. The contribution of both the two partners varies depending on the stage of the development and the innovativeness of the compound. A clinical pharmacologist and a statistician should also be involved in drafting the protocol. The participation of the latter is mandatory for multicenter trials.
精心设计的方案是任何临床试验的重要组成部分。在药物试验中，它应该是临床进行试验的医生与制药公司专家共同努力的结果。这两个合作伙伴的贡献会因药物开发阶段和化合物的创新性而有所不同。临床药理学家和统计学家也应参与方案的起草。对于多中心试验，统计学家的参与是必不可少的。
