Ethical challenges in clinical studies with adaptive design in oncology
| Autor: | Hamideh Mahdiani, Norbert W Paul |
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| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | Clinical Ethics. 18:148-154 |
| ISSN: | 1758-101X 1477-7509 |
| Popis: | Novel immune therapies are increasingly based on the molecular differentiation of disease patterns. The related clinical studies are thus more often characterized by the so-called adaptive study designs (umbrella or basket studies including platform studies), which are continuously adjusted based on novel results. This paper analyses new study designs beyond the often-postulated need for regulation in order to identify ethical problems based on typical structural features and to—whenever possible—suggest solutions. To do so, it addresses the following topics: the relationship between social and scientific values of a study as well as aspects of the scientific validity of new forms of evidence; the inclusion of study subjects under the condition of relative uncertainty; specific challenges in the process of ethical approval, and ethical and practical challenges in the process of informing patients and receiving informed consent. Additionally, the topic of a potential risk–benefit assessment of such therapies is addressed. |
| Databáze: | OpenAIRE |
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