Implementing a cancer-control study in a National Cancer Institute clinical trials network.

In this article, a case study is presented to highlight issues involved in implementing a cancer-control project through one of the National Cancer Institute's collaborative clinical trials networks. Health and Occupational Exposure to Anti-Cancer Drugs was a two-phase epidemiologic investigation that focused on clarifying occupational health risks of anticancer drug handling. The National Cancer Institute approved the study as an official cancer-control protocol and awarded Community Clinical Oncology Program (CCOP) accrual credits to participating CCOP member institutions of the National Surgical Adjuvant Breast and Bowel Project (NSABP). Implementing the study through the NSABP network and the CCOP program had major advantages, including access to large numbers of study subjects, data on a wide range of drug exposure and health outcomes, and the NSABP's excellent resources for project operations. However, accruing study subjects and completing data collection in a timely manner were major challenges. The authors discuss organizational aspects of the study and review strategies they found to be effective in dealing with various implementation issues. Investigators planning cancer-control projects and clinicians helping to implement these projects may benefit from the authors' experience.