Phase I trials: role of the nurse investigator

The role of nurses in the development, conduct, and reporting of phase I trials has in recent years become that of a clinical investigator. In collaboration with physicians and other team members, nurses are involved in every aspect of the clinical trial process and have had a favorable impact on the quality of research conducted and quality of patient care delivered. As phase I trials have achieved increasing sophistication, nursing participation at this level has become both necessary and more widely recognized. This chapter has emphasized the multifaceted and detailed responsibilities that nurses may have in phase I trials. The overall conduct and goals of phase I testing are delineated with specific nursing procedures outlined. It is of importance to recognize the contributions that skilled nurses make and the pivotal role that they play in the conduct of clinical investigation. Given the opportunity, nurses have responded to a need for their participation in clinical trials. As long as cancer continues to be a leading cause of morbidity and mortality in our society, cancer research and the development of new drug therapies will remain a priority. As the number of physicians in medical oncology approaches saturation, fewer practitioners will be trained in this subspecialty. Hence, there will be a reduction in personnel available to conduct clinical trials. With this, one may anticipate a growing need for nurses skilled in drug development and cancer treatment trials.