title: [Regulatory aspects of clinical trials with emphasis on biologicals].
abstract: Clinical trials play a central role in clinical development for achieving marketing authorization for a drug. Carefully planned and carried out clinical trials allow for valid conclusions on the efficacy and/or safety of a drug. In order to do so, various requirements have to be fulfilled: clinical studies are to be planned and conducted in accordance with Good Clinical Practice, scientifically sound methods have to be applied, the patients' safety has to be ensured, trial objectives and results have to be clinically relevant, quality and transparency of all steps from planning to reporting a clinical study have to be ensured. For biologicals, special attention has to be paid to specific aspects, such as their mode of action or possible impact on the environment. Various guidelines reflecting regulatory aspects are available to support drug development. In addition, specific questions on drug development might be discussed directly between study sponsors and regulatory agencies. Due to the changes imposed by the 12th law amending the German Drug Law (Arzneimittelgesetz), the relevant German authorities will be more involved in the planning and conduct of clinical trials.
authors.affiliation: Paul-Ehrlich-Institut, Langen. volpe@pei.de
authors.forename: P
authors.initials: P
authors.lastname: Volkers
authors.forename: S
authors.initials: S
authors.lastname: Poley-Ochmann
authors.forename: M
authors.initials: M
authors.lastname: Nübling
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D001688:Biological Products / Q000009:adverse effects* / Q000627:therapeutic use; D016265:Conflict of Interest / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004339:Drug Compounding / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D005858:Germany; D017408:Guidelines as Topic; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence*
chemical_list: D001688:Biological Products