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\begin{document}

\title{Research integrity in randomised clinical trials: an umbrella review.}



\author[1,2,3]{Maria Nunez-Nunez}%
\author[4,5]{Marta Maes-Carballo}%
\author[6]{Luciano Mignini}%
\author[7]{Patrick Chien}%
\author[8]{Yakoub Khalaf}%
\author[9]{Mohamed Fawzy}%
\author[10,11]{Javier Zamora}%
\author[11,12]{Khalid S Khan}%
\author[11,12]{Aurora Bueno-Cavanillas}%
\affil[1]{University Hospital Clínico San Cecilio, Granada, Spain}%
\affil[2]{Biomedical research institute of Granada (IBS-Granada), Granada, Spain.}%
\affil[3]{Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP-Spain), Madrid, Spain}%
\affil[4]{Complexo Hospitalario de Ourense, Ourense, Spain }%
\affil[5]{Hospital Público Verín, Ourense, Spain}%
\affil[6]{Grupo Oroño, Rosario, Argentina }%
\affil[7]{RUMC, Penang, Malaysia}%
\affil[8]{Guy's and St.Thomas NHS foundation trust}%
\affil[9]{IbnSina (Sohag), Banon (Assiut), Qena (Qena), Amshag (Sohag) IVF facilities, Egypt}%
\affil[10]{Hospital Ramón y Cajal (IRYCIS), Madrid, Spain}%
\affil[11]{Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP-Spain), Madrid, Spain.}%
\affil[12]{University of Granada Faculty of Medicine, Granada, Spain.}%


\vspace{-1em}



  
  \date{May 14, 2024}


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\begin{abstract}
Background: The trustworthiness of randomised clinical trials (RCTs) is
suffering a crisis of confidence. Objectives: We undertook an umbrella
review of the research integrity literature concerning RCTs. Search
strategy and selection criteria: Following prospective registration
(https://osf.io/3ursn), two reviewers independently searched PubMed,
Scopus, Cochrane Library and Google Scholar, without language or time
restrictions until November 2021. We included systematic reviews
covering any aspect of research integrity throughout the RCT lifecycle.
Data collection and analysis: We assessed methodological quality using a
modified AMSTAR-2 tool and collated the main findings. Main results:
There were 55 relevant reviews summarising a total of 6001 studies
(median per review 63; range 8-1106 studies). The overall quality of 53
(96.4\%) reviews was critically low. Eight (14.6\%) reviews focused on
the general aspects of a RCT, 12 (21.8\%) on the design and approval, 6
(10.9\%) on the conduct and monitoring, 21 (38.2\%) on the reporting of
protocols and findings, one (1.8\%) on post-publication concerns and 7
(12.7\%) on future research and development. The integrity issues
covered were varied, the most common being the importance of ethics
(10/55, 18.2\%) and transparency (10/55, 18.2\%). Conclusions: Various
research integrity issues covering RCT lifecycle, captured from mostly
low-quality reviews, provided a broad overview emphasising the need for
high level of ethical standards and professionalism. Many gaps in the
RCT integrity landscape were also identified. There is a need to
generate multistakeholder consensus to create specific RCT integrity
standards.%
\end{abstract}%



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