Recommendations for promoting international multi‐site clinical trials—from a viewpoint of ethics review

Nakada, Haruka; Hasthorpe, Suzanne; IJsselmuiden, Carel; Kombe, Francis; Ba, Marieme; Matei, Mihaela; Nakamura, Kenichi; Ushirozawa, Nobuko; Fujiwara, Yasuhiro; Tashiro, Seiki

doi:10.1111/dewb.12245

Cited by 3 publications

(3 citation statements)

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“…Within 12 months from the start of the war, international trials with multiple sites in general had a higher rate of updates of registration content in comparison with only Ukrainian trials (72% vs 39%). Despite multisite trials having greater complexity in contrast to single-country studies, 19 it seems that greater coordination and control, at least that related to registration update, was a possible advantage of these trials in war circumstances. Still, it is challenging to discuss whether a higher rate of updates was expected for both multination and single-nation trials.…”

Section: Discussionmentioning

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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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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Section: Discussionmentioning

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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“…Such bioethical concerns exist for controlled trials, 31 disease studies, 32 and international multi-site clinical trials. 33 Nevertheless, the current state of literature reflects the need for a deeper examination of women donor's bodily autonomy in reproductive donation.…”

Section: Context Of Bodily Autonomy Of Women Donors From the Global S...mentioning

confidence: 99%

Whose autonomy, whose interests? A donor‐focused analysis of surrogacy and egg donation from the global South

Andal¹

2023

Developing World Bioethics

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This article provides a donor‐focused analysis of how transnational reproductive donation intersects with issues central to bodily autonomy of surrogates and egg donors from the global South. Little is known about the autonomy of surrogates and egg donors, especially among those from the global South. This article addresses this gap by examining two key issues on surrogacy and egg donation—conflict of interest and recruitment market. With these issues, this paper presents contexts of the reproductive body as a space of contestation for autonomy. Analysis reveals that bodily autonomy is not an absolute entitlement available for surrogates and egg donors from the global South. Having bodily autonomy is a privileged disposition rather than a universal liberty for reproductive donors. The discussions in this work encourage further examination to understand the multi‐layered experiences of reproductive donors from the global South, towards deeper interrogation of the processes of reproductive industry.

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“…Under the previous ethical guidelines, the inefficiency and inconsistent quality of multiple reviews by ethical review committees at each institution in multi-institutional studies have been long-standing issues. In fact, the survey conducted by the Clinical Research Initiative for Global Health (CRIGH) from 2017 to 2018 to investigate the differences in ethics review systems among countries revealed that the number of ethics review committees in Japan was 1700, which was by far the highest among the countries surveyed ( 7 ). Although a central review had been acceptable under the previous ethical guidelines, each institution usually has its own institutional review board (IRB) that reviewed most cases.…”

Section: Practical Changes In the New Integrated Guidelinesmentioning

confidence: 99%

Overview of the ethical guidelines for medical and biological research involving human subjects in Japan

Eba¹,

Nakamura²

2022

Japanese Journal of Clinical Oncology

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114

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The new national guidelines for clinical research, the Ethical Guidelines for Medical and Biological Research Involving Human Subjects, were implemented in Japan in June 2021. The guidelines were developed by integrating two ethical guidelines: Ethical Guidelines for Medical and Health Research Involving Human Subjects and Ethical Guidelines for Human Genome/Gene Analysis Research. The Ethical Guidelines for Clinical Research were originally developed as three separate guidelines: Ethical Guidelines for Human Genome/Gene Analysis Research formulated in 2001, Ethical Guidelines for Epidemiological Research in 2002 and Ethical Guidelines for Clinical Research in 2003. They have undergone several amendments and integration in response to the government’s policy changes, such as the protection of personal information, conflicts of interest and reliability of clinical research. The three major changes introduced in the New Integrated Guidelines in 2021 are centralized review, electromagnetic informed consent and research cooperating organization. These are expected to be used as tools to facilitate the conduct of research. This review discusses the regulations of academic clinical research in Japan, the history of ethical guidelines and the three major changes introduced in the New Integrated Guidelines.

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Recommendations for promoting international multi‐site clinical trials—from a viewpoint of ethics review

Cited by 3 publications

References 0 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

Whose autonomy, whose interests? A donor‐focused analysis of surrogacy and egg donation from the global South

Overview of the ethical guidelines for medical and biological research involving human subjects in Japan

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