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Dose Finding CONSORT Extension Project

This project aims to develop an extension to the Consolidated Standards of Reporting Trials (CONSORT) guidance for early phase dose-finding trials.

Packet of capsule pills, ICR 2015

Background

Since its publication in 2010, the CONSORT 2010 statement which provides minimum guidelines for reporting of randomised trials, has been widely adopted for the reporting of randomised trials. Several extensions have been developed to further refine the tool for specific types of studies (e.g. adaptive designs and cluster randomised trials).

Many early phase dose-finding trials are inadequately reported and existing reporting guidelines do not fully cover features specific to dose-finding. The Dose-Finding CONSORT Extension project aims to promote complete and transparent reporting of early phase dose-finding trials and to build on the checklist outlined in the CONSORT 2010 statement.

This will be achieved through a staged consensus process involving a broad range of stakeholders, before being widely disseminated for adoption by the wider scientific community.

Increasing efficiency and transparency in early phase trial reporting will translate into a reduction of research waste and, ultimately, improve outcomes for patients.

The team

To ensure the guidelines designed are as impactful and as widely adopted as possible, a multidisciplinary team of national and international experts and early phase trial stakeholders has been brought together and is organised as follows to drive delivery of the project.

Screenshot of an online Zoom call with the whole DF CONSORT team

Executive committee

Professor Christina Yap, Institute of Cancer Research (Principal Investigator)
Dr Munyaradzi Dimairo, University of Sheffield
Professor Christopher Weir, University of Edinburgh
Professor Adrian Mander, Cardiff University
Professor Thomas Jaki, Lancaster University / University of Cambridge
Professor Jeff Evans, University of Glasgow
Dr Rong Liu, Bristol-Myers Squibb
Associate Professor Shing Lee, Columbia University
Mr Andrew Kightley, Patient and Public Involvement lead
Associate Professor Sally Hopewell, University of Oxford
Professor Johann de Bono, Institute of Cancer Research
Dr Alun Bedding, Roche
Dr Olga Solovyeva, Institute of Cancer Research
Ms Aude Espinasse, Institute of Cancer Research

Independent expert panel

Professor Deborah Ashby, Imperial College London
Professor Elizabeth Garret-Mayer, American Society of Clinical Oncology
Professor John Issacs, Newcastle University

Methodology

The Dose-Finding CONSORT extension will be developed in accordance with the EQUATOR (Enhancing the Quality and Transparency of Health Research) network’s methodological framework through a staged consensus process, involving a literature review and expert consultation to generate the candidate items.

These will be assessed by an international multi-stakeholder group in a two to three stage Delphi survey, followed by an international consensus meeting. The draft checklist will then be refined via a pilot run prior to it being finalised, as illustrated below:

Illustrated methodological framework for guideline development

The Dose-Finding CONSORT guideline development and the rapid methodological (scoping) review protocols have been published and are available from the links below:

Take part in the Delphi Survey

If you are interested in helping to develop the Dose-Finding CONSORT extension, please register your interest to take part in the Delphi Survey by completing this short online form:

Register interest to participate in the Dose-Finding CONSORT Extension Delphi Survey

Funding

MRC-NIHR Methodology Research Programme (2021 – 2023)

References

Equator Network