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

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

doi:10.1080/08989621.2026.2647346

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

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

University of Granada
IbnSina (Sohag)
RCSI & UCD Malaysia
Hospital Santa Ana
Epidemiology and Public Health Networking Biomedical Research Centre (CIBERESP)
University of Santiago de Compostela
University of Jaén
University of Manchester
University of Geneva
University of Medicine of Tirana
Evelina Women & Children's Hospital Guy's and St Thomas' NHS Foundation Trust
Egyptian IVF-ET Centre
Alexandria University
University Hospital of León
Instituto de Investigación Biosanitaria de Granada (ibs.GRANADA)
University of Modena and Reggio Emilia
Anglia Ruskin University-Chelmsford Campus
Keele University
The Royal London Hospital
Department of Obstetrics and Gynecology
University of Amsterdam
Assiut University
Hospital Escuela Eva Perón de Granadero Baigorria Santa Fe
University of British Columbia
Ain Shams University
Independent Chartered Statistician
Public and patient representative
BD Integrated Diagnostic Solutions
Shanghai Jiao Tong University School of Medicine
Rotunda Hospital
Washington University in Saint Louis
Services Institute of Medical Sciences Lahore
Sohag University

Research output: Contribution to journal › Review article › Academic › peer-review

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.

Original language	English
Article number	2647346
Pages (from-to)	2647346
Journal	Accountability in Research
Early online date	25 Mar 2026
DOIs	https://doi.org/10.1080/08989621.2026.2647346
Publication status	E-pub ahead of print - 25 Mar 2026
Externally published	Yes

Keywords

Randomized clinical trial
consensus
patient and public involvement
research integrity

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10.1080/08989621.2026.2647346

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Khan, K. S., Fawzy, M., Juhász, B., Chien, P., Martín-Díaz, M., Zamora, J., Ruano Raviña, A., Núñez-Núñez, M., Del Carmen Amezcua Prieto, M., Martínez Vázquez, S., González Casas, L., Pacey, A., Martinez de Tejada, B., Harasani, K., Khalaf, Y., Serour, G., Aboulghar, M., Sallam, H., Martín Sánchez, V., ... Bueno-Cavanillas, A. (2026). International multi-stakeholder consensus statement on patient, carer and public involvement to enhance clinical trial integrity. Accountability in Research, 2647346. Article 2647346. Advance online publication. https://doi.org/10.1080/08989621.2026.2647346

@article{e8c56329e02c4eaa836b77bb5daf42c0,

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

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.",

keywords = "Randomized clinical trial, consensus, patient and public involvement, research integrity",

author = "Khan, \{Khalid Saeed\} and Mohamed Fawzy and Bal{\'a}zs Juh{\'a}sz and Patrick Chien and Manuel Mart{\'i}n-D{\'i}az and Javier Zamora and \{Ruano Ravi{\~n}a\}, Alberto and Mar{\'i}a N{\'u}{\~n}ez-N{\'u}{\~n}ez and \{Del Carmen Amezcua Prieto\}, Maria and \{Mart{\'i}nez V{\'a}zquez\}, Sergio and \{Gonz{\'a}lez Casas\}, Le{\'o}n and Allan Pacey and \{Martinez de Tejada\}, Bego{\~n}a and Klejda Harasani and Yacoub Khalaf and Gamal Serour and Mohamed Aboulghar and Hassan Sallam and \{Mart{\'i}n S{\'a}nchez\}, Vicente and \{Oc{\'o}n Hern{\'a}ndez\}, Olga and Giovanni Grandi and Bassel Wattar and William Parry-Smith and Elizabeth Ball and \{van 't Hooft\}, Janneke and Ali Mahran and Luciano Mignini and Mohamed Bedaiwy and \{Yehia Soliman\}, Mohamed and Amr El-Shalakany and Miland Joshi and Ngawai Moss and Andrews, \{Jeffrey A\} and \{Jim Zhang\}, Jun and Michael Geary and Anthony Odibo and Tayyiba Wasim and \{Cano Ib{\'a}{\~n}ez\}, Naomi and Elsuity, \{Mohamad A\} and Aurora Bueno-Cavanillas",

note = "Publisher Copyright: {\textcopyright} 2026 Informa UK Limited, trading as Taylor \& Francis Group.",

year = "2026",

month = mar,

day = "25",

doi = "10.1080/08989621.2026.2647346",

language = "English",

pages = "2647346",

journal = "Accountability in Research",

issn = "0898-9621",

publisher = "Taylor and Francis Ltd.",

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Khan, KS, Fawzy, M, Juhász, B, Chien, P, Martín-Díaz, M, Zamora, J, Ruano Raviña, A, Núñez-Núñez, M, Del Carmen Amezcua Prieto, M, Martínez Vázquez, S, González Casas, L, Pacey, A, Martinez de Tejada, B, Harasani, K, Khalaf, Y, Serour, G, Aboulghar, M, Sallam, H, Martín Sánchez, V, Ocón Hernández, O, Grandi, G, Wattar, B, Parry-Smith, W, Ball, E, van 't Hooft, J, Mahran, A, Mignini, L, Bedaiwy, M, Yehia Soliman, M, El-Shalakany, A, Joshi, M, Moss, N, Andrews, JA, Jim Zhang, J, Geary, M, Odibo, A, Wasim, T, Cano Ibáñez, N, Elsuity, MA & Bueno-Cavanillas, A 2026, 'International multi-stakeholder consensus statement on patient, carer and public involvement to enhance clinical trial integrity', Accountability in Research, pp. 2647346. https://doi.org/10.1080/08989621.2026.2647346

TY - JOUR

T1 - International multi-stakeholder consensus statement on patient, carer and public involvement to enhance clinical trial integrity

AU - Khan, Khalid Saeed

AU - Fawzy, Mohamed

AU - Juhász, Balázs

AU - Chien, Patrick

AU - Martín-Díaz, Manuel

AU - Zamora, Javier

AU - Ruano Raviña, Alberto

AU - Núñez-Núñez, María

AU - Del Carmen Amezcua Prieto, Maria

AU - Martínez Vázquez, Sergio

AU - González Casas, León

AU - Pacey, Allan

AU - Martinez de Tejada, Begoña

AU - Harasani, Klejda

AU - Khalaf, Yacoub

AU - Serour, Gamal

AU - Aboulghar, Mohamed

AU - Sallam, Hassan

AU - Martín Sánchez, Vicente

AU - Ocón Hernández, Olga

AU - Grandi, Giovanni

AU - Wattar, Bassel

AU - Parry-Smith, William

AU - Ball, Elizabeth

AU - van 't Hooft, Janneke

AU - Mahran, Ali

AU - Mignini, Luciano

AU - Bedaiwy, Mohamed

AU - Yehia Soliman, Mohamed

AU - El-Shalakany, Amr

AU - Joshi, Miland

AU - Moss, Ngawai

AU - Andrews, Jeffrey A

AU - Jim Zhang, Jun

AU - Geary, Michael

AU - Odibo, Anthony

AU - Wasim, Tayyiba

AU - Cano Ibáñez, Naomi

AU - Elsuity, Mohamad A

AU - Bueno-Cavanillas, Aurora

PY - 2026/3/25

Y1 - 2026/3/25

N2 - 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.

AB - 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.

KW - Randomized clinical trial

KW - consensus

KW - patient and public involvement

KW - research integrity

UR - https://www.scopus.com/pages/publications/105033619385

U2 - 10.1080/08989621.2026.2647346

DO - 10.1080/08989621.2026.2647346

M3 - Review article

C2 - 41878840

SN - 0898-9621

SP - 2647346

JO - Accountability in Research

JF - Accountability in Research

M1 - 2647346

ER -

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

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