Ethical issues in cooperative cancer therapy trials from a statistical viewpoint. I. A general overview.

In conducting collaborative cancer therapy trials, investigators have an obligation to answer relevant and realistic research questions, while providing the patient with quality treatment. They should participate only in well-conceived, well-designed protocols. Their patients should follow the protocol as closely as possible. Protocol violations are admissible only in extreme cases, instances in which the patient's well-being is clearly best served by this violation. The participating clinicians have the obligation to submit quality and timely data. Finally, the results of each study must be written up in such a fashion that the reader has a clear understanding of the goals and outcomes of the trial.