Healthy Skepticism Library item: 4955

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Rosenzweig MQ, Bender CM, Brufsky AM.
The nurse as principal investigator in a pharmaceutically sponsored drug trial: considerations and challenges.
Oncol Nurs Forum 2005 Mar 5; 32:(2):293-9

Abstract:

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.

Keywords:
Clinical Trials* Drug Industry* Humans Interprofessional Relations Medical Oncology/trends Nurse's Role* Research Design Research Personnel* Research Support