[Key points in the start and conduct of a clinical trial. From question to reality in an investigator-initiated clinical trial (I)]

Abstract

Evidence-based clinical practice requires integration of individual professional experience with the best objective data to make the best therapeutic decision. The best degree of scientific evidence derives from controlled, randomized clinical trials and post-marketing drug surveillance studies and meta-analyses. During our clinical activities, we often search unsuccessfully for a clinical trial which answers our scientific questions. It is at those times that we may sometimes consider the conduct of a clinical trial. If you, as a clinical investigator, have a (relevant) scientific question that could potentially require the conduct of a clinical trial to achieve a response and have no support from a pharmaceutical company to perform it, you may find it useful to read this article, in which an attempt has been made to briefly and clearly explain the applicable regulations for planning a clinical trial. Our humble intention is that this publication becomes a useful tool for any independent researcher.