Ethical issues in cooperative cancer therapy trials from a statistical viewpoint. II. Specific issues.

Quality collaborative clinical trials cannot be run without the complete commitment of every investigator. The clinician must provide quality data and must submit the data on time. The statistical office and protocol coordinator are responsible for maintaining confidentiality and for keeping a watchful eye on the overall conduct of the study. Safety monitoring of experimental drugs or drug combinations is a central responsibility, since individual investigators generally only see the statistical reports on the study, rather than the raw data. It is critical that interim statistical reports be interpreted correctly so as not to affect accrual adversely. A separate issue discussed in this article is the answering of negative questions. Can therapy be reduced and still obtain equal efficacy? Such studies are based on sound ethical considerations, but they are hazardous since they could lead to serious worsening in cure rates.