Significant delays exist in industry-sponsored pediatric clinical drug trial start-up and enrollment processes

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-09-24 DOI:10.1016/j.cct.2024.107701

Angie Price , Hannah Simmons , Emily Gehring , Lauren Davis , Gwyneth Fischer , Ann R. Klipsch , Erin Richmond , Janice E. Sullivan , Steven J. Steiner

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引用次数: 0

Abstract

Background

Significant barriers to advancing pediatric drug development continue despite federal incentives to expedite pediatric drug development. There is an urgent need to improve how clinical trials are designed, implemented, and conducted to increase the number of approved therapeutic interventions for children.

Methods

The Pediatric Improvement Collaborative for Clinical Trials & Research was created to measure timelines and address delays in the pediatric clinical trials process. This multi-site collaborative prospectively monitored sixteen time points in industry-sponsored pediatric clinical drug trials, including times to budget approval, contract execution, ancillary protocol review, Institutional Review Board approval, Site Initiation Visit, and first patient consented.

Results

Twenty-four sites contributed data on 330 industry-sponsored pediatric drug studies. The average duration to final study budget approval was 121 (range 3–585) days, to final study Institutional Review Board (IRB) approval was 51 (range 1–205) days, to Site Initiation Visit was 204 (range 23–600) days, and to first patient consented was 239 (range 30–534) days.

Conclusion

Significant study start-up delays were noted in industry-sponsored clinical drug trials among a large group of pediatric sites. Delays and wide variation in all steps of the study process indicate multiple opportunities for improvement.

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行业赞助的儿科临床药物试验启动和注册流程存在严重延误

背景尽管联邦政府鼓励加快儿科药物开发，但推进儿科药物开发的重大障碍依然存在。我们迫切需要改进临床试验的设计、实施和进行方式，以增加获批的儿童治疗干预措施的数量。方法儿科临床试验与amp; 研究改进合作组织的成立是为了衡量儿科临床试验过程中的时间节点并解决延误问题。这个多研究机构合作组织对行业赞助的儿科临床药物试验中的 16 个时间点进行了前瞻性监测，包括从预算批准、合同执行、辅助方案审查、机构审查委员会批准、研究机构启动访问到首例患者同意的时间。最终研究预算批准的平均时间为 121 天（范围为 3-585 天），最终研究机构审查委员会 (IRB) 批准的平均时间为 51 天（范围为 1-205 天），研究机构启动访问的平均时间为 204 天（范围为 23-600 天），首次患者同意的平均时间为 239 天（范围为 30-534 天）。研究过程中所有步骤的延误和巨大差异表明有多种改进机会。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.