To help ensure that the most beneficial and safest therapies reach patients and that limited healthcare resources are invested wisely, manufacturers should be forced to show how their drugs compare to existing treatments before a new approval is issued, according to a group of UK researchers. "Numerous promising medicines have been developed," noted researchers at the London School of Economics and the European Observatory on Health Systems and Policies. "With this success comes an equally important additional need--to develop a systematic approach to evaluate the risks and benefits of these new therapies in the context of existing alternatives. An important initial step is to support a formal role for comparative efficacy evidence in drug licensing." This position is supported increasingly by the European Medicines Agency (EMA) and European Commission, they wrote in an online article published by the British Medical Journal (BMJ) on September 6. The EMA has recommended randomized active-control trials (RaCTs) when a new drug might be associated with safety or inferiority concerns, but the authors of the BMJ article propose that non-inferiority be recommended for all conditions where alternative treatment options exist. This would help to address the current variability in availability of such evidence across therapeutic areas.
Applied Clinical Trials, Oct 1, 2011