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]

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

• 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

Publication

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.

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).