Descriptions of Benefits and Risks in Consent Forms for Phase 1 Oncology Trials

Phase 1 trials of chemotherapeutic agents have been criticized because it is believed that the consent forms investigators use promise benefits and ignore risks. This study of 272 consent forms obtained from 37 academic cancer centers and six large pharmaceutical companies does not bear out the concern that consent forms for studies of experimental treatments for cancer are inadequate or ethically flawed. The main objective of phase 1 oncology trials is to determine the maximal safe dose of an investigational agent that may never have been previously tested in humans. Consequently, the prospect of direct clinical benefit to patient-subjects may be extremely low, whereas the risks may be substantial and the possible harms severe. 1 – 7 Meta-analyses place the average response rate for phase 1 oncology trials at less than 6 percent and the rate of death from toxic effects at approximately 0.5 percent. 8 – 11 The few empirical studies that have been conducted of subjects in these trials suggest that many subjects do . . .