Kerpel-Fronius Sandor, Kurihara Chieko, Crawley Francis P, Baroutsou Varvara, Becker Sander, Franke-Bray Brigitte, Matsuyama Kotone, Naseem Shehla, Schenk Johanna
Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary.
Kanagawa Dental University, Kanagawa, Japan.
Front Med (Lausanne). 2022 Aug 9;9:950409. doi: 10.3389/fmed.2022.950409. eCollection 2022.
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.
本文讨论了武装冲突、经济制裁和自然灾害对正在进行的临床试验的影响。我们认为:
• 在如此极端的条件下,停止临床试验中新增患者的招募是可以接受的。
• 在这种混乱情况下已经接受试验药物治疗的研究参与者,由于他们根据批准的临床研究方案对持续治疗存在医疗依赖,应被视为极易受伤害群体。
• 根据乌克兰和俄罗斯目前的经验,我们得出结论,无论试验中断是由于战争、经济制裁还是自然灾害,按照批准或修订的方案完成正在进行的试验治疗都应被视为试验申办者的道德义务。
• 重要的是,要更加关注此类对世界各地任何地区的临床试验造成根本性干扰的情况所引发的伦理挑战。