title: [Fundamental principles of clinical trials].
abstract: Medical conduct relies on the efficacy and tolerability of a given pharmacotherapy. On the basis of an experimental comparison of different treatment options, a clinical trial provides the foundation for an evidence-based medicine that complies with state-of-the-art scientific practice. The quality of the data assessment determines the clinical relevance of the study results. Clinical trials are classified into Phases I-IV to ensure the development of an effective and safe pharmaceutical. The investigator is responsible for being experienced in the relevant area of expertise, for conducting the study according to the investigational plan, and for complying with ethical guidelines and drug safety.
authors.affiliation: Institut für Klinische Pharmakologie, Universitätsklinikum, Frankfurt. skarke@em.uni-frankfurt.de
authors.forename: C
authors.initials: C
authors.lastname: Skarke
authors.forename: G
authors.initials: G
authors.lastname: Geisslinger
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D032781:Codes of Ethics; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000941:ethics / Q000331:legislation & jurisprudence*; D004353:Drug Evaluation, Preclinical / Q000941:ethics*; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D019317:Evidence-Based Medicine / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans