a. Establishment of the international multi-stakeholder group
In August 2021, six months ahead of the proposed consensus meeting, an
international stakeholder group was carefully composed selecting members
based on their knowledge and experience to encompass all the critical
aspects of the RCT research lifecycle. A clinical trial was defined as a
study design that randomly assigns human participants to one or more
interventions and follows them up for critical outcomes to determine the
effect of the interventions.10 Stakeholders were
representatives from: relevant professional societies; allied health
professions; patient, public and consumer representatives; trialists,
statisticians, and methodologists; members and reviewers of ethics, data
monitoring and funding committees; peer-reviewers and biomedical journal
editors. They were contacted via direct email (see the list of
stakeholders and their roles in Table 1). We ensured that none of the
participants had any RCT papers subjected to an active expression of
concern nor retraction. All stakeholders explicitly declared their
conflicts of interests using the International Committee of Medical
Journal Editors (ICMJE) uniform disclosure form (Appendix 1). One
non-voting member (DM) was invited to the group for advising on
consensus methods and language. Two members of the group were selected
as co-convenors (KSK and YK), charged with the responsibility to ensure
that all participants developed ownership of the consensus scope and
content, engaging them in discussions, constructive debates and
resolution of disagreements. Following acceptance of the invitation,
online or phone interviews were held with the stakeholders to inform
them about the project objectives, and to ask them for their input to
the integrity statements.