Pharmacology, Drug Efficacy, and the Individual

Abstract

The efficacy of drugs has to be demonstrated following the principal approach of statistical evaluation in controlled clinical trials. This scientifically and internationally accepted numerical approach has developed over the years to its importance, in contrast to the more pharmacologically attempt to extrapolate human efficacy of drugs from data obtained in animal experiments or, to the so‐called physiological medicine, which did not allow to delineate the suitability of drugs from a given collective to the individual patient. The requirements for the clinical trial are not always met, especially not with so‐called surrogate markers. In addition, concerns exist now as ever that the numerically based approach leads to average drugs and information for the “responsible adult” only, to the debit of the individual patient. The concern does not mind the clinical trial as such, which principally can be tailored to the individual as applied with pharmacogenetics. On the other hand, an unbearable situation of increased efforts towards individualization, drug tailoring, and neglect of treatment for patients with neglected diseases, respectively, is immense. The contribution of the pharmacologists is, to present those detailed information which allow proper judgement for the clinical application of drugs for all patients.

Key Words :

• Drug efficacy
• Clinical trials
• Drug regulation
• Drug tailoring
• Neglected diseases