The nurse as principal investigator in a pharmaceutically sponsored drug trial: considerations and challenges.
OBJECTIVE
To discuss the process, considerations, benefits, and challenges of the nurse as principal investigator in a cancer care drug trial.


METHODS
Published articles, anecdotal experience, and completed research studies.


RESULTS
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.


CONCLUSIONS
Oncology nurse researchers can look to pharmaceutical companies for potential funding in the evaluation of medications used in cancer care.
Rosenzweig
Margaret Q
MQ
School of Nursing, University of Pittsburgh, Pittsburgh, PA, USA. mros@pitt.edu
Bender
Catherine M
CM
Brufsky
Adam M
AM
D002986:Clinical Trials as Topic; D004345:Drug Industry; D006801:Humans; D007400:Interprofessional Relations; D008495:Medical Oncology / Q000639:trends; D024802:Nurse's Role; D012107:Research Design; D012108:Research Personnel; D012109:Research Support as Topic