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 |
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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]
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Collaborators' Responsibilities |
Co-ordination within each participating hospital will be through a local collaborator who will: |
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Co-ordinating Centre responsibilities |
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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.
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Indemnity |
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.
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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). |