Academic Lead: Dr. Deirdre Murray and Dr. Geraldine Boylan (UCC)
WP partners: DUKE, GOSHFCNT
The aim of this WP is to ensure that this study is performed to the highest ethical standards and to organise study monitoring throughout the project. Ethics and clinical safety are of primary importance in the NEMO research study particularly as it includes a randomised controlled trial of novel anticonvulsant therapy in babies. In addition, the NEMO consortium are very aware that the study group are highly vulnerable i.e. critically ill term babies who are already at high risk of long term neurological deficit. The remit of this essential work package will primarily be to supervise the ethics and safety of the clinical trial. This will be carried out through the establishment of an ethics advisory group (EAG) and a data and safety monitoring group (DSMG). The EAG will oversee the development of guidelines for the NEMO study consent form and also on parent information sheets, to ensure a uniform approach in all participating centres (in conjunction with WP 01). It is appreciated that local ethical review boards will require specific information and every effort will be made to assist local investigators in this process and to provide a central point of contact for the study for all ethical matters. Safety in the clinical trial is of paramount importance and the DSMG will oversee the development of strict procedures for the monitoring of study findings and the detection of adverse events. This will ensure the protection of all newborn infants participating in this study.
Task 1: Establishment of the ethics advisory group (EAG) for the NEMO study. The WP leaders will also establish a parent group, who will have input into the parent information leaflet and consent process.
Task 2: A systematic literature review will be conducted on the safety of phenobarbitone, midazolam, lignocaine and bumetanide for newborn babies. The review will look at current evidence for potential drug toxicity in both animals and humans. The ongoing animal research gathered during the trial will add to our knowledge of pharmacokinetics and potential side effects of bumetanide.
Task 3: Review of clinical trial protocol. The clinical trial protocol will be reviewed from an ethical perspective by the EAG and all concerns will be reported directly to the study coordinator and sponsors.
Task 4: Review of study consent forms and information sheets. Study consent forms and parental information sheets will be developed with a uniform NEMO logo. Forms will be adapted for local participating centres.
Task 5: An independent data and safety monitoring group (DSMG) will be established which will be fully independent from the participant centres and all applicants.
Task 6: To ensure that the study protocol complies with ICH GCP requirements and European laws regulating the conduct of clinical trials.
Task 7: In collaboration with the sponsors, an audit will be conducted during the course of the clinical trial which will encompass many aspects of the study. Independent auditors will be appointed to review a sample of data and study documentation taken from a representative group of study sites.
Task 8: To ensure that all serious adverse events and reactions are documented and to ensure reporting of SUSARs (Suspected Unexpected Serious Adverse Reactions) to the sponsors and all investigators in the study. The sponsors (with advice from WP 04) will report to the European Medicines Agency (EMEA) and relevant national authorities.
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