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G Kienle

Publications and source records attributed to G Kienle.

At least 19 recordsLinked to original sources
PubMed1983

Basic problems in controlled trials.

On the basis of critical discussions which have taken place in recent years in the Federal Republic of Germany, certain methodological, ethical and legal problems arising in relation to controlled trials are discussed. Because of methodological inconsistencies inherent in the experimental approach, the efficacy of a drug must in any case be judged by physicians. This leads to major ethical and even--at least in Germany--legal problems which impose considerable limits on the feasibility of controlled trials in Germany. Editor's note: This paper is written at the invitation of the journal, following the considerable controversy on the ethics of clinical trials in the European Journal of Clinical Pharmacology (8-11). A critical commentary follows the paper with a short response from the authors and a further response from the commentator.

Clinical Trials as Topic↗
PubMed1976

[Value of results of animal experiments for the evaluation of drugs. 3. Animal trials and subjective probability].

Inasmuch as the findings in pharmacology and toxicology are based on animal trials these disciplines have to be considered as subjective sciences, since the experimentally obtained objective data become medically relevant only on the basis of subjective probabilities. The value of pharmacological and toxicological tests is dependent on the quality of the investigator. Data obtained in animals trials are of no relevance for human medicine unless the investigator substantiates his subjective probabilities and at the same time demonstrates how the hypotheses won in animal trials can be verified in man. Toxicological testing methods allowing the "preselection" of drugs or any other kind of deductions without verification in man do not exist. Animal studies which are not based on the principles of decision theory serve merely as an alibi and may lead to wrong conclusions. Besides, they interfere with the German Animal Protection Law. Methodological problems can neither be solved by normative regulations of an administrative authority nor by increasing experimental activity.

Animals↗
PubMed1976

[Value of the results of animal experiments for the evaluation of drugs. 2. Methodology and prediction of effects].

The efficiency of animal trials is critically examined against the background of the new EC drug regulations. The present contributions deal with the problem of predictability of qualitative events. It is established that the so-called "pharmacological properties" of substances do not exist. Further it must be taken into account that observations made on test animals are reductionistic in relation to man. The study also shows that it is difficult to predict events with reasonable certainty even within one particular animal species. The problem of extrapolation is being viewed under three different aspects: when there is no previous experience at all, when there is relevant previous experience, and when there are animal models available. In the first case, it is impossible to make any prediction at all. In the second case, only subjective suppositions are possible. As to the third case, it is an open question at the moment whether animal models do exist at all. According to the present state of science it is not possible to make objective predictions for man on the basis of animal trials. In regard to animal trials, the EC regulations stand in contrast to science and the methodology of statistics. The subjective nature of prediction will be discussed in the following contributions.

Animals↗