Data Safety Monitoring Committee for Clinical Trials

Data Safety Monitoring Committees (DSMCs), one for each trial, with consultative functions, will be formed by independent experts external to the project, with the expertise and knowledge necessary to assist the PSC on safety grounds. Independent external experts will be asked to sign a confidentiality agreement. The DSMC’s will evaluate cumulative safety and other clinical trial data at regular intervals and will monitor the safety of patients enrolled and to be enrolled in the clinical trials at scheduled time points.

Prof. Dr. Boris Zernikow

Expert in paediatric pain. Paediatrician, specialized in paediatric pain and palliative care; Director of German Paediatric Pain Centre Children’s and Adolescent’s Hospital; Chair Children’s Pain Therapy and Paediatric Palliative Care Witten/Herdecke University, Faculty of Health, School of Medicine.

Dr. Richard Howard

Expert in paediatric pain. Anaesthesiologist. Consultant, Anaesthesia and Pain Medicine Lead Clinician for Pain Services Department of Anaesthesia and Pain Management Level 4.

Prof. Dr. Florence Tubach

Expert in methodology. Clinical methodologist at Centre de Pharmaco-épidémiologie de l’AP-HP.

Consortium

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