title: [Clinical evaluation of efficacy and adverse effects in the (European) registration of drugs: what does it mean for the doctor and patient?].
abstract: The clinical criteria for admission of new drugs to the European common market have become more stringent in recent years. Increasingly often, the manufacturer is required to demonstrate that the new drug offers a clinically visible and relevant benefit to the patient. Efficacy and adverse effects should not only be studied by comparative trials with placebo, the registration authorities also expect the drug to be compared with the standard treatment already available. Such trials should prove that the balance between efficacy and adverse effects of the drug is better than that of placebo and at least as good as the standard treatment, as regards not only statistical significance but also clinical relevance. Therefore, Dutch and European assessment reports and product information may be increasingly useful to prescribers, patients and insurers in determining the role and therapeutic value of new drugs within the existing therapeutic possibilities concerning certain diseases.
authors.affiliation: College ter beoordeling van geneesmiddelen, afd. Klinische Beoordelingen Agentschap, Den Haag.
authors.forename: P P
authors.initials: PP
authors.lastname: Koopmans
authors.forename: P A
authors.initials: PA
authors.lastname: de Graeff
authors.forename: B J
authors.initials: BJ
authors.lastname: van Zwieten-Boot
authors.forename: J F
authors.initials: JF
authors.lastname: Lekkerkerker
authors.forename: A W
authors.initials: AW
authors.lastname: Broekmans
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D003362:Cost-Benefit Analysis; D017277:Drug Approval; D005062:European Union; D006801:Humans; D009426:Netherlands; D010602:Pharmacopoeias as Topic / Q000592:standards*