Final consensus statements Agreement (%)* Agreement (%)* Agreement (%)* Underpinning information source**
Delphi 1st round (threshold 76.5%) Delphi 2nd round (threshold 68.4%)
Consensus meeting
General
Clinical trial integrity guidelines and policies must be explicit, visible, and prospectively enforceable at all levels through an implementation plan.
82.7a
SPS
Trialists, ethics committee members, journals editors and peer-reviewers should receive appropriate methodological and integrity training.
80.8a
SPS,1-7
Trial ethics committees should have accreditation and regional, national and international harmonisation of ethics assessment criteria and review process.
92.3a
8,9
There should be continuous public documentation of trials during the entire study lifecycle.
61.5
61.5
80.0
SPS
Journals should support adoption of responsible research practices in the design, conduct, analysis, reporting and archiving of trials.
88.5
SPS
Institutions should avoid excessive publication pressure.
76.9
SPS
Design and approval
Ethics approval should be obtained for all trials, including those using de-identified data.
67.3a
65.5a
100
10,11,20,21
Informed consent should be developed with patient (or their representative) and public involvement.
80.8
12,13,14,15,16
Informed consent should be examined and approved by the ethics committee.
96.2
1,12,14
Informed consent should include explicitly how the de-identified data will be shared at the time of publication or used for future analysis
73.1
65.4
96.4
17
Trials should be prioritised and resourced according to local health care needs, strategy, and culture, especially in multi-country trials including low-resource settings.
69.2
69.2f
1,12,18
Trials should be approved according to local ethics and regulatory framework, especially in multi-country trials including low-resource settings.
76.9
1,12,18
Translations of patient reported outcomes should be culturally sensitive in multi-country trials including low-resource settings.
84.6
19
Equality, diversity and inclusion should be embedded in trial design to maximize generalisability of findings.
76.9
SPS
Sample size estimation should be sufficiently detailed to permit replication.
92.3
24
Primary and secondary outcomes should follow the internationally agreed core outcomes whenever available.
80.8
SPS
The trial protocol, including ethics approval, should be prospectively registered with an open-access trial registry prior to participant recruitment. This policy should be included in research institutions‘ and sponsors‘ regulations, and researcher employment and funding contracts.
78.9a,b,f
SPS, 30,32,35
Conduct and monitoring
Trial site assessment should put in place measures to mitigate integrity breaches with the support of local research governance departments.
88.5a
SPS
There should be promotion of admission of honest or unintentional errors in the conduct of the trial without fear of blame. A part of this policy should be training.
94.2a
SPS
Innovative recruitment strategies should be participant-driven and should comply with ethics principles.
88.5
15,25,26e
Routinely collected data should be validated before analysis and reporting.
69.2
84.6
SPS, 20,27
Informed consent oversight should be part of trial audit.
92.3
10,13
The membership of independent trial steering and data monitoring committees should declare any potential conflict of interests.
100
SPS
The membership of independent trial steering committees should include patient and public stakeholders.
69.2
65.4
79.3
SPS
Minutes of the independent trial steering and data monitoring committees should be available when required.
69.2
61.5
83.0
SPS
Data monitoring committee charter should include responsibility for data integrity.
92.3
SPS,28
Centralized monitoring and selective source data verification should be deployed for ensuring data integrity.
80.8
29
There should be transparency in the method(s) of handling missing data at all stages of monitoring and reporting.
96.2
SPS
Early termination of a trial should be undertaken with the input of the independent trial steering and data monitoring committees.
96.0
SPS
Any amendment to study protocol should be reported to the trial registry (with dates). Major changes also require ethics approval.
100
SPS
The statistical analysis plan should be developed and published at the start or during the early stages of the trial before the data is made available to the investigators.
88.5
SPS
All analyses should be pre-specified from the outset (the analysis of the primary outcome and secondary outcomes, sub-group analyses, and sensitivity analyses).
84.6
SPS
There should be a single primary outcome pre-specified; when there are multiple key outcomes, valid testing strategies should be considered for maintaining familywise type-1 error within the acceptable limit of 5 %.
65.4
69.2f
SPS
Trial funders should mandate in their contract with researchers that outcomes are analysed and reported according to preregistration.
42.3
57.7
88.0
SPS
Databases for trials should include auditable access logs and permission management systems to prevent illicit access to data or editing of data.
n/ad
n/ad
100
SPS
Trial integrity and quality evidence synthesis both require the avoidance or minimisation of bias in trial conduct.
n/ad
84.6
SPS
Reporting of protocols and findings
Trialists are strongly encouraged not to submit to a predatory journal, avoiding journals without transparency and integrity.
69.2
65.4a
83.3
30
Journals’ authors’ instructions should explicitly and comprehensively cover the requirements for openness and transparency.
84.6a
SPS, 31,32,33,34
Journals´ electronic submission system should facilitate compliance with the integrity-related authors‘ instructions.
73.1
92.3
SPS
Professional medical writing could help in reporting more clearly and succinctly to meet the integrity requirements. Its contribution should be reported.
61.5
69.2f
36
The speed with which editorial and peer-review decisions are made should be balanced against the possibility of future complaints and retraction.
65.4
65.4
83.3
37
Reporting of ethics approval and informed consent details should be obligatory part of reporting guidelines and authors’ instructions.
84.6a
10,13, 14,17,38
Ethics or independent data monitoring committee should provide confirmation that the trial was conducted as planned.
61.6a
69.5a
SPS
Authorship contribution (credit according to international guidelines) should be made explicit in the manuscript.
94.3a
SPS,22,23
Trial protocol and statistical analysis plan should be submitted in unredacted form along with data set, statistical syntax and analytical outputs.
69.2
88.5
SPS,7,33
Reporting of conflict of interests, funding sources and payments received by all authors should be standardised.
78.9a
SPS,23,34,39,40,41
Declaration of conflict of interest, funding sources and payments should be mandatory for peer-reviewers and editors.
88.5
SPS
Reporting of patient and public involvement in the trial should be mandatory.
76.9
SPS
Manuscripts should be prepared according to standard reporting guidelines (e.g SPIRIT, CONSORT, GRIPP-2, etc) and their specific extensions for particular trial types (e.g. human challenge trials, trials of social and psychological interventions, etc.).
76.9a,c,f
SPS,42,43, 47
Plagiarism checks should be routinely carried out on the article main text.
84.6
44
Errors, deviations from protocol, losses to follow-up, missing outcome data and solutions applied should be transparently reported.
92.3
45,46,54
Reporting the use of data monitoring committees, its responsibilities and its membership should be mandatory.
73.1
96.2
28
Among trials conducted in various languages use of translations in patient reported outcomes should be explicit.
53.8
53.8
91.6
19
Primary and secondary outcomes should be mandatorily linked to prospectively registered outcomes.
76.9
35
Spin in writing to misrepresent, overinflate or distort the methods, findings, results and conclusions should be eliminated.
82.7a
SPS
The strengths and limitations of the integrity-related issues, as well as any flaws in terms of less-than-ideal method implementation that was unavoidable, should be discussed in the manuscript.
73.1
96.2
SPS
Post-publication
When a post-publication review detects integrity breaches, the implication is that the scientific process failed, so the focus should be on correction and learning lessons openly and collectively.
76.9
SPS
Journals have the responsibility to conduct their pre-publication assessments and peer-review in a manner so as to minimise the risk of post-publication dishonesty allegations.
92.3
SPS
Any guidance concerning post-publication integrity concerns (e.g, COPE https://publicationethics.org, https://doi.org/10.24318/o1VgCAih, https://doi.org/10.24318/cope.2019.2.4) should explicitly emphasise the investigators‘ responsibility to evaluate the integrity of the complaint and to support the trialists.
73.1
88.5
SPS
Institutions and journals should be equally supportive to the complainant(s) and author(s) in handling such complaints. There is a responsibility to protect honest trialists against harassment.
84.6a
SPS
Trialists must engage with any request for an explanation for apparent data discrepancy if required by the journal during both peer-review and post publication stages, or by systematic reviewers during evidence synthesis.
92.3
SPS
Trialists have the responsibility to keep detailed records of their trial including original protocol (with any subsequent amendments), ethics approval, details of the trial registration, de-identified raw data set, randomisation sequence employed, statistical plan, syntax and outputs of all the statistical analyses in case these are required to address any post-publication complaints.
80.8
SPS
Declaration of conflicts of interest, funding sources and payments should be mandatory for complainants.
84.6
SPS
Journals should act in an unbiased fashion transparently managing the conflict of interest of their own editors and advisors handling complaints.
80.8a
SPS
Trialists, with their institutional input, should be permitted to provide independent expert reports to the journal investigating a complaint.
76.9
SPS
If honest mistakes are identified in post publication, an erratum should be published.
96.2
SPS
Retraction notices should be clear and interpretable.
88.5
48
Post-retraction management of trials with proven misconduct should be based on a system that avoids continued citation and data misuse.
96.2
48
Future research and development
Educational effectiveness of integrity training should be evaluated.
69.2
84.6
53e
The factors influencing participant willingness to give consent for data sharing should be evaluated.
61.5
76.9
51,52
The minimum requirement for adequate informed consent should be established.
61.5
69.2
49
The criteria for and level of data auditing required during conduct of trial should be delineated.
61.5
65.4
100
10,49
The integrity remit of data monitoring committees should be clarified.
69.2
80.8
28
The best method(s) for publication credit (authorship contribution) should be determined.
65.4
88.5
50
Effective peer review models should be developed for evaluation of trials.
84.6
55
Automated checks for compliance with reporting guidelines items (e.g CONSORT, SPIRIT, GRIPP-2) should be developed.
80.8
SPS
For the raw data to be shared, journals should clarify the requirements, e.g. randomisation sequence, cleaned or original de-identified dataset, statistical codes, etc.
69.3a
92.3
SPS
The validity of early post-submission and post-publication integrity tests should be evaluated.
65.4
84.6
44
A common research terminology should be developed for prevention of selective reporting.
57.7
53.8
86.9
54
Evidence syntheses of trials using reported study-level (not raw) data should develop methods (e.g. subgroup meta-analyses or meta-regression) to evaluate integrity concerns.
n/ad
69.2f
SPS
Evidence syntheses of trials should develop methods to access patient-level (raw) data to maximize transparency.
n/ad
76.9
SPS