Conduct of device clinical trials: the need for collaboration in response to a changing health care environment.
Prior to initiating a clinical trial, many issues need to be discussed to insure an adequate understanding of the investigators' and sponsors' limitations, capabilities, and expectations. Many of these issues are addressed in contracts and agreements, the formats for which have evolved over many years. In these documents, issues such as publication rights, access to results, confidentiality, conditions for termination, compensation, and indemnification are covered. However, other essential, although noncontractual issues that reflect upon trends in and the climate of the health care system, need to be discussed. Issues such as the development of collaborative cost-effectiveness studies, public relations plans, content of a cost-benefit analysis, results of other trials, reimbursement strategies, and the development of resources that contribute to the ease, safety, and efficacy of device use. With the increasing expense, oversight, and administrative burden for the conduct and participation in clinical trials, there is a correspondingly greater need for sponsor and investigator communication, collaboration, and risk and cost sharing to ensure the successful outcome of clinical trials today.
Marks
J D
JD
Institute for Biomedical Engineering, University of Utah, Salt Lake City 84103-1414, USA.
D002986:Clinical Trials as Topic; D017047:Cost Sharing; D003362:Cost-Benefit Analysis; D003695:Delivery of Health Care; D004864:Equipment and Supplies; D006801:Humans