[Participation by the established physician in clinical drug trials].
After performance of the phases I to III of the drug test which is carried out in clinics and special institutions into the phase IV, the ambulatory test, mainly the physician with own practice is included. This test is performed either as a controlled study with clearly outlined test aim and methodology or as open study in which physician and patient known which medicaments are used. Before the physician participates in a clinical study he should for himself carry out a preliminary test. Thereby he should carefully consider the proportionality of the necessity of the testing against possible dangers for the individual and also the feasibility of the test in his practice with its patients. An important prerequisite is the presence of a test plan, whereby the information and the consent of the patients or test person is decisive for the permissibility of the test. The producer of the test preparation takes the total responsibility for the clinical test including the liability.
Broglie
M G
MG
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D005858:Germany; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D016365:Liability, Legal; D010819:Physician's Role
Teilnahme des niedergelassenen Arztes an Arzneimittelprüfungen.