) The purpose of this award is to provide 75 percent """"""""protected time"""""""" for the Candidate, as a newly-independent investigator, to develop a research program drawing on previous experiences in clinical, translational, and cancer prevention/control sciences. As Director of Clinical Research in a University-based Cancer Center, the Candidate is in a unique and ideal position to develop a comprehensive program investigating the educational, behavioral, cognitive, and applied ethical aspects of oncology clinical trials. The proposed Research Plan addresses issues raised in PA-99-079, """"""""Research on Ethical Issues in Human Studies"""""""", and an R01 application will be submitted to the NIH in response to this PA. Preliminary work in this area has already been conducted by the Candidate. The hypothesis of the proposal is: The current approach used for informed decision-making by potential subjects for oncology clinical trials impedes the ability of patients to comprehend the essential elements of research studies, and impacts effective recruitment, retention, and compliance for these trials.
The specific aims of the project are to: 1) investigate the effects of specific interventions on potential subjects' measured comprehension of clinical trials; 2) determine the outcomes of different strategies for oncology patient recruitment, retention, and compliance; 3) compare the risk:benefit appraisal process used by potential subjects in oncology vs. non-oncology settings; and 4) study the consequences of planned and possible future use of collected tissues or cells as laboratory correlates on decision-making about therapeutic trials. The initial year of the project will be directed toward completion of analysis and publication of preliminary data, with submission of the R01 application by the end of Year 2. By the conclusion of the third year of the program, the Candidate should be well-positioned to implement a program of independent research with extramural funding support. Findings from these investigations would contribute toward significantly improving outcomes in clinical trials as well as the ability to accrue adequate numbers of subjects to answer critical questions in cancer prevention, therapy, and correlative science.
