Different Methods of Assessment of New Technologies and Medical Devices

Clinical evidence available for the assessment of medical devices (MD) is frequently insufficient. New MDs should be subjected to high quality clinical studies to demonstrate their interest for patients. The randomized controlled trial (RCT) is the study design reaching the highest level of evidence in order to demonstrate the efficacy of a new MD. This type of trial reduces the risk of bias that it does not reveal whether the observed differences are related to the new treatment or other factors. However, the clinical context of some MDs makes it difficult to carry out a conventional RCT. Other experimental designs can thus be proposed to demonstrate the clinical efficacy of new MDs.Zelen’s design trials and randomized consent design trials facilitate the recruitment of patients, but can rise ethical problems. Expertise-based randomized controlled trials involve randomizing to a team that specializes in a given intervention. Sometimes, the feasibility of an expertise-based randomized trial may be greater than that of a conventional trial. Crossover trials reduce the number of patients, but are not applicable when a learning curve is required. Sequential trials have the advantage of allowing to stop early a trial depending on the results of first inclusions, but they require an independent committee. Bayesian methods combine existing information with information from the ongoing trial. These methods are particularly useful in situations where the number of subjects is small. The disadvantage is the risk of including erroneous prior information. Although, the RCTs are applicable in many situations. The previous methods can meet the diversity of situations existing with MDs.