Trial Protocol Back


Steering Committee
Dr Colin Baigent
Clinical Trial Service Unit

University of Oxford
Professor John Pickard
Department of Neurosurgery

University of Cambridge
Professor David Chadwick (Chair)
Walton Centre for Neurology and Neurosurgery University of Liverpool
Professor Ian Roberts (co-ordinator)
CRASH Co-ordinating Centre

London School of Hygiene & Tropical Medicine
Dr Lelia Duley
Research Centre for Randomised Trials

University of Oxford
Mr Jonathan Wasserberg
Department of Neurosurgery

University of Birmingham
Professor Marcel Haegi
Fédération Européenne des Victimes de la Route (FEVR)
Professor David Yates
Department of Accident & Emergency Medicine University of Manchester
Professor Maggie Pearson
NHS R&D Programme

NHS Executive North-West


Data Monitoring Committee
Professor Rory Collins Professor Stephen MacMahon (Chair)
Professor Stephen Haines

The independent Data Monitoring Committee will conduct interim analyses of mortality and morbidity among all trial participants. It will advise the Steering Group if the randomised comparisons in the trial provide both (i) proof beyond reasonable doubt of a difference in outcome between the study and control groups, and (ii) evidence that would be expected to alter substantially the choice of treatment for patients whose doctors are, in the light of the evidence from other randomised trials, substantially uncertain whether to give corticosteroids to patients with head injury.[Ref 15]


Collaborators' Responsibilities

Co-ordination within each participating hospital will be through a local collaborator who will:

  • Discuss the trial with medical, neurosurgical and nursing staff who see trauma patients and ensure that they remain aware of the trial and its procedures. There are posters and a set of electronic slides (a PowerPoint presentation) to assist with this.

  • Ensure that adults with acute head injuries are considered promptly for the trial

  • Ensure that the Early Outcome Forms are completed

Co-ordinating Centre responsibilities
  • Provide study materials and a 24-hour randomisation (and unblinding) service

  • Give collaborators regular information about the progress of the study

  • Help ensure complete data collection at discharge and at six months

  • Respond to any questions (e.g. from collaborators) about the trial



The success of CRASH will be entirely dependent upon the collaboration of nurses and doctors in the participating hospitals. Hence, the chief credit for the study will be assigned to them in the main publications, and the collaborators from each participating centre will be named personally in the main report.



The CRASH trial is sponsored by the Medical Research Council (MRC) and not the manufacturers of methylprednisolone. The MRC fully accepts responsibility attached to its sponsorship of the trial, and as such, would give sympathetic consideration to claims for any non-negligent harm suffered by anyone as a result of participating in this trial.


Financial support

Medical Research Council funding covers meetings and central organisational costs only. Pharmacia Corporation are donating drug and placebo, but the design, management and finance of the study are entirely independent of them. Methylprednisolone is not a new product. Really large trials of such drugs, involving many hospitals, are important for future patients but are practicable only if those collaborating in them do so without payment (except for recompense of any minor local costs that may arise).