The responsibility for the study protocol in a drug trial.

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.