title: [Barriers to clinical studies involving medical devices].
abstract: Clinical trials with medical devices need to be considered in terms of the complexity of surgical procedures. Creating the proper environment for the conduct of trials includes improved academic career opportunities in the field of clinical research, methodological competence, and established structures. The challenges and pitfalls in the design of clinical trials involving medical devices are based on aspects such as blinding, placebo, learning curves and surgeons' expertise. Surgical procedures should be standardised, and a study hypothesis needs to be established which is answerable by a relevant and feasible sample size. Besides the above-mentioned challenges, efficient interactions between authorities, universities, hospitals, and medical device manufacturers are mandatory to allow for quality and relevance of clinical studies in this field.
authors: Aesculap AG, Tuttlingen. moritz.wente@aesculap.de
authors: Moritz N
authors: MN
authors: Wente
mesh_terms: D018849:Controlled Clinical Trials as Topic / Q000592:standards*; D018795:Device Approval; D004059:Diffusion of Innovation; D004864:Equipment and Supplies / Q000592:standards*; D005858:Germany; D006801:Humans; D009313:National Health Programs; D011358:Product Surveillance, Postmarketing / Q000592:standards; D011785:Quality Assurance, Health Care / Q000592:standards*; D013523:Surgical Equipment / Q000592:standards*; D013525:Surgical Instruments / Q000592:standards*