Human Clinical Trials

Medical research is important for many reasons not least of which is to determine clinical efficacy, safety, and cost-effectiveness of any therapeutic interventions to ensure equitable distribution of scarce healthcare resources for the maximal benefit of society. It was the recognition of this need that led to the concept of the evidence-based medicine (EBM) which was introduced and developed over 30 years ago. For many years, a well-designed randomized controlled trial (RCT), published in a high-impact journal, was seen to be the best way to advance clinical practice, and there is little doubt that this approach has significantly advanced clinical practice. However, it has become increasingly apparent that researchers are under considerable pressure to produce positive results in order to either secure funding for ongoing research or enhance their own and/or institutional academic reputation. Such apparent conflict of interest, which is almost never declared, has led to a clear publication bias that has seen many negative trials either go unpublished or be misrepresented in a favourable manner that is not fully supported by detailed examination of the basic data.