The continuation of clinical trials in times of war: A need to develop ethics and situationally adaptive clinical research guidelines

Kurihara, Chieko; Crawley, Francis P.; Baroutsou, Varvara; Becker, Sander; Franke-Bray, Brigitte; Granville, Courtney A.; Matsuyama, Kotone; Naseem, Shehla; Schenk, Johanna; Kerpel-Fronius, Sandor

doi:10.3389/fmed.2022.966220

Cited by 6 publications

(4 citation statements)

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“…In addition, a new registry item or field could be introduced to address unexpected circumstances requiring alteration of the trial protocol. 24 …”

Section: Discussionmentioning

confidence: 99%

“…ClinicalTrials.gov quality control professionals should pay special attention to ongoing trials conducted in a country or countries affected by the war and contact investigators if no updates are posted after a reasonable time. In addition, a new registry item or field could be introduced to address unexpected circumstances requiring alteration of the trial protocol 24.…”

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confidence: 99%

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Changes in Registration Parameters for Ongoing Clinical Trials in Ukraine After 2022 Russian Invasion

Gujinović,

Viđak,

Melnikova

et al. 2023

JAMA Netw Open

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ImportanceClinical trial activity in Ukraine was seriously affected by the Russian invasion. However, data are lacking on how this conflict affects clinical trials.ObjectiveTo evaluate whether registered changes to trial information reflect war-related disturbances to trials in Ukraine.Design, Setting, and ParticipantsThis cross-sectional study included noncompleted trials conducted in Ukraine from February 24, 2022, to February 24, 2023. Trials conducted in Estonia and Slovakia were also analyzed for comparison. Study records within the ClinicalTrials.gov archive were accessed by using the change history feature in the tabular view for each record.ExposureRussian invasion of Ukraine.Main Outcomes and MeasuresThe frequency of changes to the protocol and results registration parameters before and after the start of the war, February 24, 2022.ResultsA total of 888 ongoing trials conducted only in Ukraine (5.2%) or in multiple countries (94.8%), and enrolling a median of 348 participants were analyzed. Almost all sponsors for 775 industry-funded trials were non-Ukrainian (99.6%). On February 24, 2023, 267 trials (30.1%) were without any recorded update in the registry after the war. In 15 (1.7%) multisite trials, Ukraine was removed as a location country after mean (SD) of 9.4 (3.0) postwar months. The rates of changes in 20 parameters 1 year before and after the war started had a mean (SD) absolute difference of 3.0% (2.5%). Besides study status changes in each study record version, the contacts and locations field was the most frequently modified (56.1%), with a higher rate for multisite (58.2%) than in only Ukrainian (17.4%) trials. This finding was consistent for all analyzed registration parameters. In trials conducted solely in Ukraine, the median number of record versions was the year before (95% CI, 0-0) and after February 2022 (95% CI, 0-1), similar to registered trials from Estonia and Slovakia.Conclusions and RelevanceResults of this study suggest that war-related changes in trial conduct in Ukraine may not be completely visible in the largest public trial registry, which is expected to present accurate and timely information on clinical trials. These findings raise questions regarding the updating practices for registration information, which should be mandatory, especially in times of crises, to ensure the safety and the rights of trial participants in a war zone.

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“…In addition, a new registry item or field could be introduced to address unexpected circumstances requiring alteration of the trial protocol. 24 …”

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Changes in Registration Parameters for Ongoing Clinical Trials in Ukraine After 2022 Russian Invasion

Gujinović,

Viđak,

Melnikova

et al. 2023

JAMA Netw Open

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“…Other unprecedented situations of clinical trials in war/conflict, as well as natural disasters, highlighted the needs of patients seeking access to investigational intervention ( 39 , 40 ). Sponsors, investigators, and regulators ( 41–43 ), undertook joint efforts to continue or start investigational treatment for patients with acute needs, and developed procedures for adherence to GCP under disruptive circumstances, including the cases of emigrations.…”

Section: Placebo Control and Post-trial Accessmentioning

confidence: 99%

Declaration of Helsinki: ethical norm in pursuit of common global goals

Kurihara,

Kerpel-Fronius,

Becker

et al. 2024

Front. Med.

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The World Medical Association’s Declaration of Helsinki is in the process of being revised. The following amendments are recommended to be incorporated in pursuit of the common goal of promoting health for all. 1. Data-driven research that facilitates broad informed consent and dynamic consent, assuring participant’s rights, and the sharing of individual participant data (IPD) and research results to promote open science and generate social value. 2. Risk minimisation in a placebo-controlled study and post-trial access to the best-proven interventions for all who need them. 3. A future-oriented research framework for co-creation with all the relevant stakeholders.

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“…, 2. , 3 , 4. Most recently, the coronavirus disease-2019 (COVID-19) pandemic presented significant challenges for the conduct of many cardiovascular clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Operational challenges and mitigation measures during the COVID-19 pandemic–Lessons from DELIVER

Bhatt

Lindholm

Nilsson

et al. 2023

American Heart Journal

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The continuation of clinical trials in times of war: A need to develop ethics and situationally adaptive clinical research guidelines

Abstract: and Kerpel-Fronius S ( ) The continuation of clinical trials in times of war: A need to develop ethics and situationally adaptive clinical research guidelines.

Cited by 6 publications

References 4 publications

Changes in Registration Parameters for Ongoing Clinical Trials in Ukraine After 2022 Russian Invasion

Changes in Registration Parameters for Ongoing Clinical Trials in Ukraine After 2022 Russian Invasion

Declaration of Helsinki: ethical norm in pursuit of common global goals

Operational challenges and mitigation measures during the COVID-19 pandemic–Lessons from DELIVER

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