The ethical responsibility to continue investigational treatments of research participants in situation of armed conflicts, economic sanctions or natural catastrophes - PubMed (original) (raw)

The ethical responsibility to continue investigational treatments of research participants in situation of armed conflicts, economic sanctions or natural catastrophes

Sandor Kerpel-Fronius et al. Front Med (Lausanne). 2022.

Abstract

This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes on ongoing clinical trials. We suggest that • stopping the accrual of new patients in clinical trials under such extreme conditions is acceptable. • research participants already receiving trial medication in such disruptive situations are to be considered highly vulnerable due to their medical dependency for ongoing treatment according to the approved clinical study protocol. • based on the present experience in Ukraine and Russia, we conclude that finishing ongoing trial treatments according to approved or amended protocols should be considered to be an ethical obligation of trial sponsors irrespective whether trial disruption is due to war, economic sanctions, or natural catastrophes. • it is important to devote more attention to the ethical challenges raised by such fundamentally disruptive situations to clinical trials generally in any region of the world.

Keywords: Ukraine war; clinical trials; economic sanctions; ethics; investigational treatment; vulnerable population.

Copyright © 2022 Kerpel-Fronius, Kurihara, Crawley, Baroutsou, Becker, Franke-Bray, Matsuyama, Naseem and Schenk.

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Conflict of interest statement

Author SN was employed by Ferozsons Laboratories Ltd and JS was employed by PPH plus GmbH & Co. KG. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

References

    1. IFAPP Working Group of Ethics . Investigational Drug Supply for Seriously ill Patients in Time of War. IFAPP TODAY. No 23. April 2022. Available online at: https://ifapp.org/blog/ifapp-today-april-2022-number-23 (accessed April 27, 2022).
    1. Rubin R. Clinical trials during war in Ukraine. JAMA. (2022) 22:5571. 10.1001/jama.2022.5571 -DOI -PubMed
    1. Castañeda R. Ukraine: Industry-sponsored clinical development at risk. Clinical Trials Arena. (2022). Available online at: https://www.clinicaltrialsarena.com/analysis/ukraine-industry-sponsored-... (accessed April 27, 2022).
    1. Browne G . “The war puts ukraine's clinical trials—and patients—in Jeopardy,” In: Hundreds of trials have been disrupted in the medical research hub. Some patients are at risk of losing their last chance at survival. Science. (2022). Available online at: https://www.wired.com/story/war-ukraine-clinical-trials-jeopardy/ (accessed April 27, 2022).
    1. Fontanarosa PB, Flanagin A, Golub RN. Catastrophic health consequences of the war in Ukraine. JAMA. (2022) 2:6046. 10.1001/jama.2022.6046 -DOI -PubMed

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