Observational Research

Abstract

The randomized controlled clinical trial, or experimental approach, is considered to be the “gold standard” for the evaluation of medical device safety and effectiveness, and constitutes the basis of the approval process for many medical devices.¹ One of the most important reasons why this method is preferred is that, through the randomization process, it is more likely to lead to an unbiased interpretation of results than other types of study designs, as described in Chapter 1. It should be recognized, however, that there are situations in which the experimental approach is either not feasible because of cost or practical limitations (e.g., a rare disease), or unethical as in circumstances where no alternative therapy exists. Occasionally, nonrandomized concurrent controlled trials or even observational studies based on sound historical data may be considered valid alternatives in the evaluation of devices.²