The ACE Project

When undertaking a clinical trial an adaptive design (AD) has the potential to offer efficiency in addressing study research objectives, as well as ethical advantages by minimising the number of patients who are randomised and value for money in clinical trials research. However, despite their advantages, there are multifaceted barriers and concerns hampering the routine application of ADs such as a lack of practical knowledge and limited access to case studies (Dimairo, Boote, et al., 2015; Dimairo, Julious, et al., 2015).

The fact that the few accessible AD case studies are poorly reported undermine their usefulness as a learning resources and prevents them from being added to the practical knowledge base (Hatfield et al., 2016; Stevely et al., 2015). The inadequate description or reporting of ADs is also one of the leading concerns with respect to the perceived credibility of their findings to assist in robust decision making (Dimairo, Julious, et al., 2015; Stevely et al., 2015). These concerns could limit the ability of trials with an AD to change clinical practice. Transparency and adequate reporting of published ADs is a key facilitator to improve credibility of ADs, their usefulness as learning resources, and their appropriate uptake in clinical trials research. The lack of a reporting guidance on ADs has led to the recommendation that CONSORT be extended to cover these studies (Cytel, 2016; Detry et al., 2012; Stevely et al., 2015).

The ACE Project aims to develop a consensus driven reporting guidance tailored for ADs in the form of a CONSORT extension. We hope this will enhance transparency, credibility, reproducibility, and replicability of adaptive trials. The hope would be to facilitate uptake of ADs in clinical trials research when appropriate.

The ACE Project is jointly funded by the NIHR and MRC HTMR, 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 Investigator: Dr Munya Dimairo (m.dimairo@sheffield.ac.uk ) or the Study Coordinator: Ms Katie Biggs (c.e.biggs@sheffield.ac.uk).

If you are interested in taking part in the Delphi survey, you can contact us as above, or register using this link: surveys.npeu.ox.ac.uk/index.php/survey/index/sid/143519/newtest/Y/lang/en

Project Team

Name Role Organisation
Dr Munya Dimairo Lead Investigator University of Sheffield
Ms Katie Biggs Study Coordinator University of Sheffield
Dr Daniel Hind Co-Applicant University of shefield
Prof Susan Todd Co-Applicant University of Reading
Prof Steven Julious Co-Applicant University of Sheffield
Prof Jon Nicholl Co-Applicant University of Sheffield
Dr James Wason Co-Applicant MRC Biostatistics Unit, Cambridge
Dr Adrian Mander Co-Applicant MRC Biostatistics Unit, Cambridge
Prof Christopher Weir Co-Applicant University of Edinburgh
Prof Thomas Jaki Co-Applicant Lancaster University
Dr Franz Koenig Co-Applicant Medical University of Vienna, Austria
Prof Doug Altman Collaborator University of Oxford
Prof Toshimitsu Hamasaki Collaborator National Cerebral and Cardiovascular Center (NCVC), Japan
Dr Michael Proschan Collaborator National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), U.S.A.
Dr Marc Walton Collaborator Janssen Pharmaceuticals, U.S.A.
Dr John Scott Collaborator Food and Drug Administration (FDA), U.S.A.
Dr Yuki Ando Collaborator Pharmaceuticals and Medical Devices Agency, Japan