Methodology for the evaluation and measurement of therapeutic progress.

When a candidate drug is likely to become available to prescribers and healthcare policy makers, evaluation of therapeutic progress moves forward in two stages. First, the level of expected therapeutic progress must be established. This first stage requires the determination of therapeutic needs and the comparison of these against the results of the clinical studies that will form the basis of the marketing authorisation of the drug. This determination helps anticipate the therapeutic progress that is attributable to the approved use of the new drug. The second stage of the process, the evaluation of the actual therapeutic progress, involves therapeutic drug monitoring and bases itself on observation. Since such observational data are intended to challenge the initial hypotheses and uncertainties (in terms of benefits and risks), goals and methods must be laid out before the drug becomes available to the general public.