The NEMO trial is a pan European Multicentre clinical trial conducted across 6 Member States. The trial received its first “green Light” to start recruitment in August 2011 and the first participant was enrolled in October 2011. Since the project commenced the NEMO core trial office team have met on a regular basis to discuss study related issues and offer support to the clinical trial site . The NEMO core trial office members are a unique partnership of UCC, GOSH, O4CP and UCL. This partnership spans four languages, three countries and two time zones making for some interesting meetings.
Staff at all the clinical trial sites have shown great dedication and great effort to make this study work. Despite this recruitment to the trial has been difficult for various reasons. There is no question that the logistics of this trial have been challenging for the clinical sites and we can only hope that the trial office has been as supportive as possible to match the dedication of everybody involved. The Trial Steering committee met in November 2012 and agreed, after an analysis of the trial data already collected that an early termination should be next step for the NEMO-1 study and the relevant authorities in each relevant Member State were notified. The study monitor has visited all the clinical trial sites and conducted a “study close out visit.” A date for database lock was also proposed and this has just recently been achieved.
Taking into account the various legislative requirements and local practices within each Member State the greatest achievement of NEMO-1 has been the successful recruitment of patients, across Europe, into a neonatal study in an intensive care setting. The NEMO consortium consisting of researchers with a strong scientific and/or clinical background in the fields of neonatology, neurophysiology, pharmacology or epilepsy clinicians across Europe and USA has proven to be a strong collaboration capable of conducting research to the highest standards. Working with the consortium been most rewarding and their collaborative approach is an excellent accomplishment.
The NEMO study has been conducted to the highest ethical and regulatory standards and it is clearly evident at all times that the trial personnel have felt the heat of the need for ensuring documentation is completed accurately and filed accordingly. The Core NEMO trial office would like to thank and congratulate all the Investigators and their research teams for their exceptional work to ensure the successful execution of this trial. The next phase of the project is being discussed at present and we hope that NEMO-2 will be agreed on at the upcoming meeting in Brussels in April.
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