The ACE Project Registration Questionnaire

The ACE Project Registration Questionnaire

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About the Adaptive designs CONSORT Extension (ACE) project

Adaptive designs (ADs) offer opportunities to use accumulating trial data to change aspects of that ongoing clinical trial while preserving its validity and integrity. Despite the potential benefits of well-conducted ADs, there are obstacles hindering their routine use in clinical trials research. Recent research found inadequate reporting of adaptive trials, which may influence their credibility, usefulness to learn from and apply, and to inform future related research. Transparent adequate reporting is one of the key facilitators in which some of these barriers and concerns to the use of ADs can be overcome.

This project, therefore, aims to develop a consensus-driven reporting guidance tailored randomised controlled trials conducted using ADs, which assess the efficacy and effectiveness or safety of human healthcare interventions. This will be an extension to the existing CONSORT 2010 guidance and will be applicable across trial phases. We hope this reporting guidance will enhance the credibility of ADs, help reduce research waste, and improve reproducibility and replicability of adaptive trials.

We are asking you to take part in round 2 of the Delphi surveys in order to identify the key reporting items/aspects that need to be included in the ACE reporting guidance that is under development.

The project is jointly funded by the NIHR CTU Support Funding stream and MRC Hubs and is led by a multidisciplinary Steering Working Group of international experts in collaboration with the CONSORT Executive Group and the MRC HTMR Adaptive Designs Working Group. For more details or queries, please contact the lead (Dr Munya Dimairo m.dimairo@sheffield.ac.uk).

Please click the links below to view the protocol and information sheet for this survey:

Protocol

Information Sheet

There are 12 questions in this survey.
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