The ethical side of clinical tests during phase I in oncological therapy

Abstract

The article begins by giving explaining the domination in biomedical experimentation of research leading to the production and implementation of new medicines. The description of these factors serves as an introduction to the fundamental section of the article that discusses the specific features of clinical tests during phase I of oncological therapy. They include above all such elements as the choice of human subjects from among the terminally ill and the non-therapeutic character of the experiments with an accompanying small statistical background of significant effects. The above features are the basic source of ethical dilemmas connected with phase I tests. In the article the following four most important factors have been analyzed:
1. the practical impossibility of obtaining an informed consent of the human subject for participating in the test,
2. the blurring of the border between therapy and experiment, leading to the treatment of phase I experiments as especially valuable though non-cost-effective therapeutic procedures,
3. the blurring of the distinction between a physician-therapist and a physician-researcher,
4. the tendency on the part of physicians and patients to treat phase I experiments as a way to avoid difficult conversations and decisions after all therapeutic options have been exhausted.