Background: Many hospitals run extensive clinical trial divisions. Renal medicine is no longer an exception. Medications have reached the marketplace in the past without being trialed on subjects with renal impairment. In the last 5 – 10 years this has changed dramatically as medications previously not given to subjects with renal disease are being found to be potentially beneficial in this population. Nurses play an important role in the potential for improved care.
Aim: To increase the knowledge, understanding and awareness of the role of clinical trials in the presence of kidney disease, and the process behind the appearance of the drug on the pharmacy shelf from a nursing perspective.
Discussion: Our clinical trials department employs 3 nurses with an average of 14 years experience in nephrology nursing. Currently we coordinate 22 trials ranging from Phase II to Phase IV, involving approximately 200 subjects. Trials are sponsored by drug companies, others are nephrologist driven, or in collaboration with local/international universities. The processes involved in clinical trial coordination are complex. These involve the development, recruitment, maintenance and cessation of studies under the International Code of Harmonisation Good Clinical Practice code of practice. The importance of the nursing role in this process will be presented.
Clinical Implications: Increasingly nurses are finding their way into roles within clinical trials that benefit people living with renal disease. This is a move away from the more traditional bedside care of the patient and has extensive implications for improving future outcomes for these patients.