The Challenges of Conducting Clinical Research: The Investigators Perspective

Background
As new drugs/devices are developed and demands for evidence based care increase, the need for qualified nurses to serve as investigators in clinical trials is growing. Some nurses have extensive experience serving as investigators for various types of clinical research; however, many nurses have limited to no experience in this area. Those who have participated as investigators for clinical research studies have unique insight into its challenges. Nurses who participated as site investigators in a recent clinical trial were asked to share their perspective.

Objective
To share experience and insight gained by participating as investigators for a clinical trial and to educate ETs and WOC nurses on challenges encountered and opportunities revealed by participating in clinical research.

Methods
A recent industry-sponsored multi-site medical device study was conducted in the United Kingdom. Many nurse investigators for this study had experience with case studies and/or product evaluations but limited experience with clinical trials. The challenges they discovered, the impact this type of research had on subject care, and what they gained from the experience was obtained through interviews.

Outcomes
Nurse investigators noted the following challenges: time constraints, extensive study paperwork, subject recruitment, institutional processes and study timelines. While nurses reported having difficulties finding time to participate in the study, they also felt it was necessary and gratifying to contribute toward improvement of patient care.

Conclusion
Nurses are well positioned to undertake research studies due to their clinical skills and patient access. However, nurses undertaking this study felt they needed more clinical research education. To better prepare nurses for challenges of clinical research, further training needs to be provided; along with an improved hospital support system and recognition of the value research provides. These changes may increase nurse participation in clinical studies, resulting in improved patient care and evidence based practice.