Certain BRA quantitative methods use utility scores or patient preferences in their computation. Such approaches are limited, as patient preferences are not available for all conditions. Also patients suffering from a life-threatening disorder such as cancer might not assess a given ADR the same way as patients suffering from a less severe disorder such as depression.

It is unclear to what extent one could compare the utility-based approaches Inhibitors,research,lifescience,medical with a subjective and individualized assessment to the evidencebased appraisal of drugs. than Another limitation of quantitative BRA methods is the risk of oversimplification of the parameters of the benefitrisk ratio; the NNH:NNT ratio is an example of a mathematical tool too simple to capture the complexity of the problem. This review focuses on the public health perspective, ie, the BRA for the population of potential patients: this is the view of the regulatory authorities and that of the pharmaceutical industry. The BRA based on Inhibitors,research,lifescience,medical average values represents what one could expect for the population of patients (in clinical trials or pharmacoepidemiological studies). For a given patient, the efficacy and

safety of a given treatment can differ, Inhibitors,research,lifescience,medical and often does, from what was concluded on the basis of a population of patients: a patient can be a responder or a nonresponder to a drug, and the efficacy of a medically recognized drug can be null at the individual level. Similarly, the individual safety profile often differs from the average safety profile seen in a population. The subjective perception Inhibitors,research,lifescience,medical ol an ADR also plays a role: a given ADR can be tolerated by certain patients, but may be unacceptable

to others. In this sense, the MCDA technique reduced to the individual level is very similar to decision analysis, an economic technique Inhibitors,research,lifescience,medical whose use has been suggested in medicine since the 1960s34: the BRA integrates probabilities in its computation and one can use it to determine lor a given patient what the best alternative is. In conclusion, the BRA is a dynamic Cilengitide MDV3100 process that evolves according to the cumulated knowledge acquired on drugs, mainly on their safety, as well as on more general conditions such as acceptance of risks in public health terms, or the existence of therapeutic alternatives. Clearly, the evidence from randomized clinical trials is critical to furnish the bases for the BRA before registration of the drug, but collecting information on the patients exposed once the drug is marketed is critical to pursue the BRA process during the life cycle of the drugs.? Contributor Information François Curtin, GeNeuro SA, Plan les Ouates, Switzerland. Pierre Schulz, Clinical Psychopharmacology Unit, Geneva University Hospital, Geneva Medical Faculty, Switzerland.
The primary goal in designing an RCT is to minimize the bias in the estimate of the treatment effect.