|DATA MONITORING AND ETHICS COMMITTEE
Ensuring the safety and rights of trial participants is the most important consideration for everyone working on the CRASH trial but the Data Monitoring and Ethics Committee (DMEC) has a special responsibility. From time to time during the trial the DMEC will assess the effect of the treatment on death and disability. It will advise the CRASH Trial Steering Committee if the trial data provide:
(1) proof beyond reasonable doubt of a difference in outcome between the
Selected by the Medical Research Council to represent the necessary clinical and statistical expertise, the DMEC includes professors in neurosurgery, neurology, medicine and epidemiology. Last month the committee met to consider the results of the first interim analyses from the CRASH trial. The report is excellent news for everyone working on the CRASH trial. It can be summarised in four words:
Congratulations go to Andrea Sauerland, Research Sister at the University Hospital in Zurich who randomised the first Swiss patient in to the trial.
Hola - María Angeles Muñoz-Sanchez. Trauma Centre ‘Virgen del Rocio’ is the first hospital in Spain ready to start recruiting patients.
We now have a second centre in Belgium recruiting patients in to the trial. Véronique Braet randomised the first patient at A.Z. Kliena Hospital within a week of receiving treatment packs.
Top 5 recruiting centres:
|THIS MONTHS FREQUENTLY
Q. What if the patient is drunk?
A. Patients with head injury and impaired consciousness are eligible for inclusion in the CRASH Trial if the responsible doctor is substantially uncertain as to the appropriateness of steroids in a particular patient. The question of whether the impaired consciousness in a head injured patient who has been drinking or using drugs is attributable to the head injury or to substance use is a matter of judgement for the responsible clinician.
Hence, judgements about both the impaired consciousness and about the appropriateness of corticosteroids are relevant when considering the enrolment of a patient. If the responsible doctor is substantially certain that an intoxicated patient with head injury will not benefit from steroids they should not be entered into the trial. However, all those for whom the responsible doctor is substantially uncertain as to whether or not to give corticosteroids are eligible for randomisation.
FACE IN THE CO-ORDINATING CENTRE
Hi everyone! My name is Maria Ramos and I started in May to begin the mammoth task of administering the CRASH team, after eight years as an Infant school administrator - and I am just beginning to realise what I took on… Working with an enthusiastic team of highly motivated professionals is proving to be a truly exhilarating experience and I am absolutely delighted to have been given the chance.
However, I have come across
one minor problem. One of my jobs is to enter the Early Outcome Forms
on the CRASH database and - just occasionally -
|I would really appreciate
it if you could print the names and addresses clearly as well as complete
the information in every section of the form; this would save you having
to spend time responding to my nagging queries.
No doubt you’ll be hearing from me at some time, also, feel free to contact me if you have any problems with the Early Outcome Forms, trial supplies or patient data
CRASH Co-ordinating Centre, FREEPOST LON 14211, LONDON WC1N 1BR
Tel: + 44 (0)20 7299 4684 Fax: + 44 (0)20 7299 4663 email: CRASH@lshtm.ac.uk