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American Society for Experimental Neurotherapeutics Abstracts
February 2002

Conduct of Clinical Trials: The Principal Investigator's Perspective

Arch Neurol. 2002;59(2):325. doi:

Research investigators have unique responsibilities to protect human subjects participating in clinical trials. Investigators must use their clinical and professional judgment in areas that are not readily reviewed by institutional review boards (IRBs).

The investigator must be able to respond affirmatively to 3 questions regarding the research protocol

(1) Does the protocol ask an important enough scientific question to justify the required resources of the investigators and research participants? (2) Is there a reasonable likelihood that the study can be completed as designed? and (3) Is it likely that the completed study will answer the research question?

In the special setting of a randomized intervention study, the investigator must be certain that there is clinical equipoise regarding the alternative treatment assignments. Clinical equipoise implies that the scientific community is in a state of genuine uncertainty regarding the relative merits of different interventions, including, in the special setting of placebo-controlled trials, no intervention. Only the investigator can make an educated assessment of this situation. Even if clinical equipoise exists, if the investigator has a deeply held personal bias regarding treatment alternatives, participation as an investigator is unwise.

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