title: [Benefits and harms - two sides of the same medal?].
abstract: Efficacy, efficiency, value, and harm constitute the terminology that is used to decide about drug licensing and reimbursement. This article discusses to what extent legal requirements dictate the way clinical trials are planned and assessed. Cardiovascular disease is the best example of indications where efficacy and safety are described with the same set of endpoints. It is explained that the assessment of clinical trials must not be restricted to the assessment of primary endpoints. Instead components of a composite endpoint, secondary endpoints, and relevant subgroups of the patient population all require careful inspection. In cases where efficacy and safety are not two sides of the same medal, assessment is either trivial, or extremely difficult, and eventually benefit and risk can be balanced only for individual cases.
authors.affiliation: Institut für Biometrie, Medizinische Hochschule Hannover. Koch.Armin@mh-hannover.de
authors.forename: Armin
authors.initials: A
authors.lastname: Koch
mesh_terms: D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000401:mortality; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy / Q000401:mortality; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions; D023381:Endpoint Determination; D005858:Germany; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D007356:Insurance, Pharmaceutical Services / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D000077154:Rosiglitazone; D016019:Survival Analysis; D045162:Thiazolidinediones / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D002317:Cardiovascular Agents; D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone