International multi-stakeholder consensus statement on patient, carer and public involvement to enhance clinical trial integrity.

IF 4.4 1区哲学 Q1 MEDICAL ETHICS

Accountability in Research-Policies and Quality Assurance Pub Date : 2026-10-01 Epub Date: 2026-03-25 DOI:10.1080/08989621.2026.2647346

Khalid Saeed Khan, Mohamed Fawzy, Balázs Juhász, Patrick Chien, Manuel Martín-Díaz, Javier Zamora, Alberto Ruano Raviña, María Núñez-Núñez, Maria Del Carmen Amezcua Prieto, Sergio Martínez Vázquez, León González Casas, Allan Pacey, Begoña Martinez de Tejada, Klejda Harasani, Yacoub Khalaf, Gamal Serour, Mohamed Aboulghar, Hassan Sallam, Vicente Martín Sánchez, Olga Ocón Hernández, Giovanni Grandi, Bassel Wattar, William Parry-Smith, Elizabeth Ball, Janneke van 't Hooft, Ali Mahran, Luciano Mignini, Mohamed Bedaiwy, Mohamed Yehia Soliman, Amr El-Shalakany, Miland Joshi, Ngawai Moss, Jeffrey A Andrews, Jun Jim Zhang, Michael Geary, Anthony Odibo, Tayyiba Wasim, Naomi Cano Ibáñez, Mohamad A Elsuity, Aurora Bueno-Cavanillas

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引用次数: 0

Abstract

Background: The recent update of the Declaration of Helsinki has emphasized community engagement and research integrity. Patient, carer and public involvement (PCPI) throughout the research lifecycle of randomized clinical trials (RCTs) can enhance their integrity. However, no specific PCPI guidance exists for trialists. The Cairo Consensus Group on Research Integrity, consisting of 40 stakeholders from 14 countries, developed a statement to address this gap.

Methods: The project was prospectively registered at the Open Science Framework (https://osf.io/fqepb). Based on the findings of a literature review and a stakeholder consultation, an initial long list of recommendations was created. It was submitted to a two-round modified Delphi survey before being finalized in a hybrid online-face-to-face meeting.

Results: The modified Delphi survey response rate was 63% (29/46) for the first round, and 65% (30/46) for the second round. The initial long list consisted of 46 statements, and nine additional statements were provided during the consensus process. The final set consolidated 39 statements, grouped into seven categories: General; Design, Approval and Funding; Conduct and Monitoring; Reporting of protocols and findings; Dissemination and Implementation; and Future Research and Development.

Conclusion: This international consensus statement is expected to help organizations implement PCPI to enhance RCT integrity.

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关于患者、护理人员和公众参与以加强临床试验完整性的国际多利益相关者共识声明。

背景：最近更新的《赫尔辛基宣言》强调了社区参与和研究诚信。在随机临床试验（RCTs）的整个研究周期中，患者、护理者和公众参与（PCPI）可以提高其完整性。然而，没有具体的PCPI指导存在的试验。由来自14个国家的40个利益攸关方组成的开罗研究诚信共识小组制定了一项声明，以解决这一差距。方法：该项目在开放科学框架（https://osf.io/fqepb）上进行前瞻性注册。根据文献综述和利益相关者咨询的结果，初步制定了一份长长的建议清单。该方案经过了两轮修改后的德尔菲调查，然后在一次混合在线面对面会议上最终确定。结果：第一轮修正德尔菲调查的应答率为63%(29/46)，第二轮修正德尔菲调查的应答率为65%（30/46）。最初的长清单包括46个发言，在协商一致过程中又增加了9个发言。最后一组合并了39份报表，分为7类：一般报表；设计、审批及资助；行为和监测；报告方案和调查结果；传播和执行；未来研究与发展。结论：本国际共识声明有望帮助组织实施PCPI以提高随机对照试验的完整性。

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

Accountability in Research-Policies and Quality Assurance MEDICAL ETHICS-

CiteScore

4.90

自引率

14.70%

发文量

审稿时长

>12 weeks

期刊介绍： Accountability in Research: Policies and Quality Assurance is devoted to the examination and critical analysis of systems for maximizing integrity in the conduct of research. It provides an interdisciplinary, international forum for the development of ethics, procedures, standards policies, and concepts to encourage the ethical conduct of research and to enhance the validity of research results. The journal welcomes views on advancing the integrity of research in the fields of general and multidisciplinary sciences, medicine, law, economics, statistics, management studies, public policy, politics, sociology, history, psychology, philosophy, ethics, and information science. All submitted manuscripts are subject to initial appraisal by the Editor, and if found suitable for further consideration, to peer review by independent, anonymous expert referees.