Expanding the role of the nurse in clinical trials: the nursing summaries

Abstract

In order to improve the overall quality of clinical trials, the role of the nurse should be expanded. The minimum requirement to facilitate nurses' participation and the optimal implementation of a clinical research protocol is to provide access to the clinical protocol document itself. However, given the high workload in an oncology unit, there is often little time for the staff to read the entire document. In addition, clinical protocols do not often provide detailed practical instructions for delivering treatment, observing patients, managing toxicities, and treating complications. A nursing summary of the medical protocol is a document that provides a short and easy-to-read selection of protocol-relevant information. It enables nurses to safely and more easily implement the research protocol and improve the care of patients in clinical trials. Master nursing summaries can be prepared centrally by the group responsible for the research protocol, while the unit/wards involved in the research can customize or adapt it to local needs. The potential benefit of implementing nursing summaries is overall improvement of the quality of the study by (a) increasing the reliability of nursing care regarding patients' safety, (b) standardizing monitoring and care of patients, (c) standardizing preventive measures, (d) proposing similar management of complications related to experimental treatments. Moreover, discussing nursing summaries may help evaluate workload related to research, allowing for better planning and allocation of resources.

Validating the Clinical Research Nursing Domain of Practice

“…Several U.S. universities offer certificate and degree programs in clinical research, with a focus on managing research activities and regulatory affairs, writing research grants, developing managerial skills to facilitate the implementation of clinical research, integrating and applying good clinical practice guidelines, maintaining ethics and conduct of responsible research, and research data management. Second, a significant number of standardized continuing education programs also are available to educate healthcare professionals from all disciplines in the conduct of clinical trials (Arant et al, 2007; Di Giulio et al, 1996). …”

An Innovative Approach to the Care of Patients on Phase I and Phase II Clinical Trials: The Role of the Experimental Therapeutics Nurse

“…Common themes emerge, and the role of nursing in all phases of clinical trials is seen as having a broad scope and a wide variety of responsibilities. Roles consistently mentioned include that of educator, advocate, ally, facilitator, care coordinator, multidisciplinary liaison, clinical interpreter, data collector, direct patient caregiver, counselor, technical advisor, and skilled observer (Adams, 1994;Cassidy & Macfarlane, 1991;Cogliano-Shutta, 1986;DiGiulio et al, 1996;Engel-king, 1991;Hazelton, 1991;Hubbard, 1982;McEvoy, Cannon, & MacDermott, 1991;Sadler et al, 1999;Wheeler, 1991;White-Hershey & Nevidjon, 1990). Sadler et al (1999) asserted that nursing is called to partner with the patient in promoting, recruiting, educating, and supporting him or her through clinical trial participation.…”

Role boundaries – research nurse or clinical nurse specialist? A literature review

“…Giulio et al . (1996) provide anecdotal evidence about the research nurse role and suggest that nurse involvement in clinical trials is difficult because of lack of clarity about their role.…”