Compliance in early-phase cancer clinical trials research.

Regulations and ethical principles require that investigators seek consent and that patients participate in experimental studies only under circumstances that minimize the possibility of undue pressure and/or enticements. In recent years, there has been a rapid rise in the monitoring requirements of early-phase trials accompanied by an increasing emphasis on assuring "investigator" compliance with the protocol. It is actually, however, the patient who must comply with the requirements of the study. If there is divergence from the protocol, investigators may be reported to regulatory bodies or agencies. Whereas the investigative community is expected to be vigilant about ensuring that patients participate in studies voluntarily and that their consent is procured without duress, it is also required to guarantee that complex protocols, which entail multiple procedures, be followed exactly by participants who suffer from the complications of advanced cancer. We explore the issue of compliance in a research environment in which investigators are subject to disciplinary action if they fail to ensure that patients adhere precisely to the intense monitoring mandates of a clinical trial.