Aim To provide an overview of governance issues relating to medical-device trials and practical advice for nurses wishing to initiate or lead them.
Background Medical-device trials, which are formal research studies that examine the benefits and risks of therapeutic medical devices, have traditionally been the domain of physicians and scientists. The role of nurses in these trials has historically been as data collectors or co-ordinators rather than as principal investigators. However, nurses have more recently played an increasing role in initiating and leading medical device trials.
Review methods A review article of nurse-led trials of medical devices.
Discussion Central to the quality and safety of all clinical trials is adherence to the International Conference on Harmonisation Guidelines for Good Clinical Practice, which is the internationally agreed standard for the ethically and scientifically sound design, conduct and monitoring of a medical-device trial, as well as the analysis, reporting and verification of the data derived from that trial. Considerations include the class of the medical device, type of trial, regulatory status of the device, implementation of standard operating procedures, obligations of the trial sponsor, indemnity of relevant parties, scrutiny of the trial conduct, trial registration, and reporting and publication of the results.
Conclusion Nurse-led trials of medical devices are demanding but rewarding research enterprises. As nursing practice and research increasingly embrace technical interventions, it is vital that nurse researchers contemplating such trials understand and implement the principles of good clinical practice to protect study participants and the research team.