Clinical Trials 2008; 5: 630RESPONSE Response to Commentaries

We appreciate the thoughtful commentaries on our article concerning the appraisal of benefit in phase 1 oncology trials. Weinfurt notes three sources of uncertainty about benefit for individual trial participants in addition to the two sources of uncertainty (i.e., uncertainty about the causal relationship of phase 1 agents to stable disease, and uncertainty about the connection between surrogate outcomes assessed in these trials and clinical outcomes relating to survival and quality of life) that we discussed in detail. Although we argued, and Weinfurt agrees, that prospective trial participants need to be informed about the uncer-tainty of personal benefit in phase 1 oncology research, we do not believe that informed consen