Ethics and drug development

Published on April 27, 2022   23 min

Other Talks in the Category: Clinical Practice

Dear audience, it is a pleasure for me to give you the presentation on "Ethics and Drug Development". My name is Christian Lenk. I'm a Professor of Medical Ethics at the Institute for the History, Theory, and Ethics of Medicine at Ulm University in Germany.
You see here the contents of my talk. Firstly, I will say something regarding the ethical framework for clinical research and medicine. Then I will explain something about the research ethics committees, which are also named in the United States as the Institutional Review Board. In the third part, I will then go on to ethical questions and the research design with elements of the research design like, for example, randomisation, placebo control and blinding. The fourth part will be shortly on vulnerable patient groups and I will say then also something on the challenges in the COVID-19 pandemic regarding ethics and research. Finally, I will draw some conclusions for practice.
The Ethical Framework for Clinical Research. This framework here was developed by some colleagues from the United States, Emanuel, Wendler and Grady in a publication from 2000. Well, as they showed in their publication first, the medical research should also have some social and scientific value over and above the mere progress of medicine. So the researchers should also reflect on this kind value. Often research projects are only acceptable for the broader society one can show but there's also social and scientific value in the aims of these research experiments. The second point is the scientific validity. The methods and the experiments in the clinical trial must be according to the standards of research. Then there should be a fair subject selection, for example, in special population groups who could profit from this treatment should also then be part of the trial and should be recruited in such a trial. The fourth point would be the favorable risk-benefit ratio. At the start of the trial, but also during the trial, the benefits for the patients and participants should overlay the existing risks in this trial. Then there should be in the fifth point an independent review and control of such an experiment. And very important on the sixth, every participant must be freely, and give a well informed consent to participate in the study. Finally, on the seventh, we have also the respect of the researchers and organizers for potential and enrolled subjects and study participants.