18 MAY 2020
By David Tuller, DrPH
In a well-designed clinical trial, the protocol, the registration and the statistical analysis plan should complement and not contradict each other. Investigators spend huge amounts of time developing clinical trial protocols. These are road-maps to the project, complete with (hopefully) well thought-out and clearly defined primary and secondary outcomes. These documents have to pass muster with oversight and ethics committees and often go through multiple iterations before final approval–and funding.
Before recruiting patients, investigators are supposed to open an entry for their clinical trial in a recognized registry. This trial registration is expected to include the same primary and secondary outcomes as in the protocol. When the investigators draw up a statistical analysis plan, it is supposed to explain in greater deal how the data for the primary and secondary outcomes listed in both the protocol and trial registration are to be analyzed.
It goes without saying that the published report of any clinical trial is expected to adhere to its own predesignated primary and secondary outcomes, as noted in the protocol, registration, and statistical analysis plan. That is, unless the investigators have obtained permission from appropriate oversight committees to make necessary changes after providing adequate justification. If this occurs, such changes should be disclosed in the published account........................
