Ethics in clinical research.
R&D of new drugs is driven by pharmaceutical companies that invest considerable amounts of money for this purpose. This may introduce bias, to emphasize the clinical value of drugs to be allowed onto the market. Bias is caused by methodological flaws including the population under study, the choice of inadequate comparators or of their dosage, the adoption of surrogate or composite endpoints, the decision to publish mainly positive findings or to overlook some safety concerns, etc. All this happens in a legal context that requires no added value for new drugs to be approved for the market. This encourages the use of placebo even when active comparators are available, or the search for non-inferiority of new products in comparison with active comparators. Superiority over placebo and non-inferiority to active comparators may allow drugs onto the market that are in fact less active (or safe, tolerable, convenient, etc.) than those already available, usually with consolidated properties and lower costs. In addition, they do not meet patients' or physicians' needs of defining the place in therapy and respective roles of new and available treatments. The current legislative and regulatory setting seems designed to meet commercial interests rather than public health needs.
Garattini
Silvio
S
Mario Negri Institute for Pharmacological Research, Via G. La Masa 19, 20156 Milan, Italy. garattini@marionegri.it
Bertele'
Vittorio
V
D016907:Adverse Drug Reaction Reporting Systems / Q000941:ethics; D035843:Biomedical Research / Q000941:ethics*; D002986:Clinical Trials as Topic / Q000941:ethics; D055808:Drug Discovery / Q000941:ethics; D023381:Endpoint Determination; D006801:Humans; D010919:Placebos; D011643:Publishing / Q000941:ethics; D016032:Randomized Controlled Trials as Topic / Q000941:ethics
D010919:Placebos