[Current methodologies and clinical research].

Abstract

Clinical research is like health, which although is said to be priceless, has a cost however. This cost is currently reaching record levels which will be, without any doubt, broken in years to come. Providing patients with more effective molecules, better tolerated or likely to save more lives, is definitely a priority. Everything should be undertaken in order to save time and money. By interrupting the development of a compound proven to be useless, the subsequent savings may be reinvested in the development of another promising drug. This is the reason why Ethical Committees, Regulatory Agencies, clinicians and statisticians are carefully looking at the way to sort out the issue of the right balance between the most exhaustive evaluation of a new substance, in order to minimize potential risks, and the expeditious launch unto markets of supposedly effective drugs in severe or fatal diseases which currently lack truly adequate treatments. These two pitfalls can be named "too early" or "too late". New methodologies are now in the process of seeing the light of day. They tend to reconcile different constraints, either by reducing the clinical trial length or by decreasing the calculated number of enrolled patients, or even by dealing with both parameters. They call more for " bayesian " or " frequentist " methods than for traditional statistics. Several approaches are currently used, namely adaptive strategy.