Data Monitoring Committee says well done and keep recruiting…

Every MRC trial must have a Data Monitoring and Ethics Committee (DMEC). The role of the DMEC is to look at the un-blinded trial data from an ethical standpoint, with the safety, rights and well being of the trial participants being paramount. The CRASH trial DMEC met last month to review the outcome data for the 5070 patients recruited up until the end of March 2003. This is what they said…

"It was the view of the DMEC that the available data provide no cause to recommend any change to the study procedures or to plans for expansion of patient recruitment. The DMEC commended the CRASH study organisers and collaborators on their continuing success with recruitment and follow-up. The DMEC fully endorses the plans of the study investigators to continue recruitment until 20,000 patients have been randomised."

This is good news for the CRASH trial. It means that we can continue to recruit patients and to expand the trial with full confidence for patient safety. Keep up the good work and as ever, keep randomising.

Assuring the quality of data in a clinical trial as large as CRASH is a complex task. However, the trial Co-ordinating Centre's responsibility is clear. In line with the International Conference on Harmonisation (ICH) guidelines we are 'responsible for implementing and maintaining quality assurance and quality control systems with written standard operating procedures to ensure that trials are conducted and data generated, documented and reported in compliance with the protocol, good clinical practices and the applicable regulatory requirements.’

In the CRASH Trial we agree to comply to Good Clinical Practice (GCP) standards. This ensures that the trial data is reliable, processed correctly and valid. We use several approaches to assess data quality:

1. All data received are subject to statistical checks which involve automatic flagging of data that fall outside of error specifications. Those that fall outside this range generate an error alert message.
2. We aim to monitor and verify between 5 - 100% of data at each centre against source documents.
3. We carry out random checking of medical records to ensure patients are randomised appropriately.

We would like to thank those collaborators (pictures on the right), who have had full site audits and those who have had source data verification done, for their assistance with these processes. So far, data verification has shown that the data we receive is of a high quality. Thanks to everyone who is responsible for data collection for doing such a great job.

First patient

• Aida Madrazo Carnero, Hospital V.I. Lenin, Cuba
• Gladys Rivas Canino, Hospital Miguel Enriquez, Cuba
• Jaime Velasquez Tapia, Hospital Naval, Ecuador
• Roberto Santos, Hospital Regional del IESS “Dr. Teodoro Maldonado Carbo“, Ecuador
• Jose Edmundo Mezquita, Complejo Hospitalario M. A. Guerrero, Panama
• Johan Du Preez, Nelspruit Medi Clinic, South Africa
• Miguel Angel Arruego Minguillón, Hospital Universitario de Girona “Dr Josep Trueta”, Spain
• David Foley and Trevor Parry, Queen Mary's Hospital, UK

10 patients

• Walter Videtta, Hospital Nacional Profesor Alejandro Posadas, Argentina
• Maximiliano Waschbusch, Policlinico Sofia T de Santamarina, Argentina
• Luis Camputaro, Hospital Italiano, Argentina
• Jesus Quiñones, Hospital San Andres, Colombia
• Marcos Iraola Ferrer, Hospital Universitario "Dr Gustavo Aldereguia Lima“, Cuba
• Tamar Gogichaisvili, Republican Hospital, Georgia
• Urs Denzler, Kantonsspital Schaffhausen, Switzerland
• Colin Read and John McCarron, Russell's Hall Hospital, UK
• Lawrence Jaffey and Michael Graves, Royal Liverpool University Hospital, UK

New ethics approvals

• Fatos Olldashi, National Trauma Center Hospital, Albania
• Hernán Galimberti, Hospital Aleman, Argentina
• Sylvia Fitzal, Wilhelminenspital der Stadt Wien, Austria
• Alexander Petkov, Military Medical Academy, Bulgaria
• Richard Hall and Lisa Julien, Queen Elizabeth II Health Sciences Centre, Canada
• Libardo Pulido, Hospital Regional De Duitama, Colombia
• Lucijan Negovetic, UH "Sestre milosrdnice“, Croatia
• Ahmed Yehia Elhuseny, Zagazig University Hospital, Egypt 1ST PATIENT
• P Ulrich and Elke Januschek, Städtische Kliniken Offenbach/Main, Germany
• S N Iyengar, G R Medical College, Gwalior, India
• K Bhavadasan, Kerala Medical College Hospital, India
• P V Ramana, Care Hospital, India
• Esmaeel Fakharian, Naghavi University Hospital, Iran 1ST PATIENT
• Alfredo Cabrera Rayo, Hospital Regional "10 de Octubre" ISSSTE, Mexico
• Jesus Martinez Sanchez, The American British Cowdray Medical Centre, I.A.P, Mexico
• B B Shehu, Usmanu Danfodiyo University Teaching Hospital, Nigeria
• Rashid Jooma, Jinnah Postgraduate Medical Centre, Pakistan
• Jose Walter Valverde, Complejo Hospitalario Metropolitano CSS, Panama
• Diana Rodriguez, "Arzobispo Loayza National Hospital" Ministry of Health, Peru
• Ernesto de Carvalho, Hospital Geral de Santo Antonio, Portugal
• Vladimir Kollarik, NsP F D Roosevelt, Slovakia
• Dr Sona Medekova, NsP Nové Zámky, Slovakia
• Vitaliy Sipity, Kharkiv Medical University, Ukraine
• John Thurston, Darent Valley Hospital, UK

50 patients

• Mamdouh Alamin, Aswan Teaching Hospital, Egypt

• Mario Izurieta Ulloa, Hospital Luis Vernaza, Ecuador
  

100 patients

• Reto Stocker and Silke Ludwig, University Hospital Zurich, Switzerland

• Alvaro Ardila Otero and Wilson Gualteros, Hospital Universitario San Jorge, Colombia

200 patients

Surakrant Yutthakasemsunt,
Khon Kaen Regional Hospital, Thailand

300 patients

Guy Mazairac,Centre Hospitalier Regional de Namur, Belgium

Six-month Outcome
To minimise the chances of causing distress to the families and relatives of patients who have died, it is essential that EOFs are complete and returned to the Co-ordinating Centre within a few weeks of enrolment. This will ensure that the lists of patients who are due for follow-up exclude those patients who have died. In the UK we also contact the patient’s GP (family doctor) for all patients who were dependent at 14 days, to check that the patient is still alive before follow-up starts. Please ensure that information about head injury related symptoms and GP details are complete on all EOFs.

EASTERN EUROPE
1,034

SOUTH EAST ASIA AND OCEANIA
577

MIDDLE EAST AND
NORTH AFRICA
530

SOUTHERN AFRICA – 408

INDIA AND
SRI LANKA – 220