European Clinical Trial Medical Device Regulation and the Protection of Human Participants /

Abstract

The focus of this research is in the area of European clinical trial regulation for medical devices to determine if the health and welfare of human participants is protected. There were four questions to be addressed: 1) Evaluation of clinical trial history to determine the evolution and lessons learned from the past 2) Evaluation of European medical device regulation to determine if it adequately protects the welfare of human participants in clinical trials 3) Evaluation and review of a real-life case study to identify if weaknesses exist in the medical device clinical trial regulation and process which would put human participants at risk 4) Identify what other factors affect the protection of human participants in medical device clinical trials. These research questions were addressed by applying various research methodologies which included an in-depth literature review of European regulation, in-depth personal interviews and a case study analysis. The research produced a number of key findings. Clinical research has evolved and advanced significantly and has brought benefits to patients and society as a whole. European medical device regulation has evolved to protect the health and well-being of human participants in clinical trials. However, regulation does not cover every conceivable scenario, and challenges still exist with ensuring that the regulations are followed. The research recommended several changes that could address the current weaknesses which put human participants lives at risk during clinical trials, such as; the merging of regulations for medical devices and drugs for clinical trials into one regulation; having the presence of representatives from the ethics committee, competent authority and clinical experts when informed consent is being processed to ensure that no bias or undue force is exercised to any participant; regulation updates every three years to keep in line with scientific and technological advances; mandatory quarterly audits by the competent authority and ethics committee for clinical trials initiated by physicians or hospitals; legally binding contracts for the publication of clinical trial results to prevent inaccurate or inconsistent information reaching the public domain and any conflicts of interest could be declared to the authorities with the clinical trial submission.