[Therapeutic trial, clinical research and therapeutic freedom--medical aspects].
In the history of medicine, the approach has changed from prevention to curative medicine- hand in hand with the availability of the pharmacologic findings. Prior to the era of a medicine based on natural science, drugs were found by an empirical trial- and error approach resulting in a steadily growing of drugs. With the upcoming natural sciences, medicine reached new levels in drug treatment by extensive and systematic research in experimental and clinical trials. For scientific and regulatory acceptance, national and international guidelines and the rules of "Good Clinical Practice" have to be met. On the basis of the respect for the "Oath of Hippocrates", the commitment to "salus aegroti suprema lex", the responsibility of "nil nocere" and the duty of information are elementary. The regulations of the "social legislation" define rights and duties of patients and physicians. In spite of all these rules, the physicians' autonomy is undeniable because of individualism of patients in contrast to the clinical trials based on national and international guidelines.
Loew
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Johann Wolfgang Goethe Universität, Institut für Klinische Pharmakologie, Frankfurt.
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004992:Ethics, Medical; D005858:Germany; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*
Heilversuch, klinische Forschung und Therapiefreiheit--ärztliche Aspekte.