The nurse as principal investigator in a pharmaceutically sponsored drug trial: considerations and challenges.

PURPOSE/OBJECTIVES To discuss the process, considerations, benefits, and challenges of the nurse as principal investigator in a cancer care drug trial. DATA SOURCES Published articles, anecdotal experience, and completed research studies. DATA SYNTHESIS The specific processes that must be considered are funding sources, protocol development, trial implementation, dissemination of results, and ethical implications involved in industry sponsorship. Specific protocols are designed for evaluating adverse events. Working with pharmaceutical companies to receive financial support offers advantages but poses additional issues for consideration. CONCLUSIONS Nurses can serve successfully as principal investigators in medication trials for cancer care. Regulatory bodies and specific procedures, as well as general considerations, mandate and guide investigator conduct when embarking on a pharmaceutical trial. IMPLICATIONS FOR NURSING Oncology nurse researchers can look to pharmaceutical companies for potential funding in the evaluation of medications used in cancer care.