Materials

Issue 109: Meyer, Frank P.: Salus aegroti suprema lex; Probleme klinischer Studien aus der Sicht eines Mitgliedes einer Ethikkommission - Schwerpunkt Onkologie. August 1996

Ethics committees are established and function for public reassurance to protect volunteers and patients in clinics and practice from hazardous research projects. According to the German Physicians' Code the physician, prior to conducting epidemiological research that involves data related to persons, is required to consult an ethics committee on issues of professional ethics and legal problem areas associated with the particular project. The controlling function of the ethics committee also implies that the test schedule's suitability be scrutinized while allowing for state-of-the-art scientific findings available for achieving the objective of the study. There are various reasons why oncologic studies are a particular problem area: (1) For a great many substances, appropriate efficacy studies have not been conducted to date, neither do any comprehensible recommendations exist. (2) With a view to trying out new therapy concepts most varied combinations of chemotherapy are being clinically tested in patients, even though toxicologic data of such combinations have not been revealed. (3) The risk involved in subjecting nonresponders to an excessive therapy is usually underestimated, considering that response is often restricted to judging surrogate criteria only. (4) Information provided to patients involves numerous problems. General deficiencies of clinical studies relate to so-called competing studies, to incorporating placebos, and to getting new test centres involved subsequently. Proper conducting of the clinical study, as well as the weal and woe of the patients involved are the testing physician's responsibility. The increasing confidence crisis between the doctor and the patient, causing many patients to resort to a medical practice other than scientifically substantiated medicine should be minimised, through empathic handling of local clinical testing, and it should not be intensified.