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Standard Development Group: Data Monitoring and Sample Size

Our goal is to provide guidelines for (1) the decision when to install a DMC, the composition of a DMC and the tasks and responsibilities of a DMC and for (2) obtaining adequate sample sizes in pediatric randomised clinical trials. The guidelines will preferably be based on empirical evidence.  In the absence of suitable evidence the guideline will be based on consensus. The target group consists of all professionals involved in clinical research with children, including funders, statisticians, ethics committees, Data Monitoring Committees, regulators, and journal editors.

Hanneke van der Lee
Ingeborg Van der Tweel
Ricardo Fernandes
Ben Vandermeer
Martin Offringa

Hanneke van der Lee


Affiliation: Senior epidemiologist, Pediatric clinical Research Office, Woman-Child Centre Academic Medical Center Amsterdam, the Netherlands

Research interests: clinical trial methodology in rare (pediatric) diseases, parent and patient participation in clinical research, clinimetrics

Current projects: developing standards for rare disease registries and involvement of parents and patients in the design of clinical trials, investigating individualized outcome measures for use in rare disease trials

Ingeborg Van der Tweel

Affiliation: Biostatistician, University Medical Center Utrecht, the Netherlands

Research interests: Efficient design and analysis of clinical trials; sequential analysis; interim analyses; (sequential) meta-analysis.

Current projects: statistical methodology for the combination of series of trials in rare diseases; estimation of heterogeneity between studies; safety monitoring in clinical trials.

Ricardo M Fernandes

Affiliation: Attending pediatrician, Department of Pediatrics, Hospital Santa Maria, Lisbon’s Academic Medical Centre; Lecturer and clinical researcher, Faculty of Medicine, University of Lisbon, and Clinical Pharmacology Unit, Instituto de Medicina Molecular Molecular; Co-Director, Cochrane Child Health Field.

Research interests: Clinical research interests – pediatric respiratory disease, allergy and emergency medicine; methodological topics – research on outcomes and measurement, clinical trial design, conduct and data monitoring, and systematics reviews and meta-analysis.

Current projects: improving trial design and selecting patient-relevant and valid outcomes and outcome measurements in acute and chronic pediatric respiratory conditions such as bronchiolitis and recurrent wheezing disorders; developing methods to conduct overviews of systematic reviews in child health; improving methods to disseminate high-quality pediatric evidence.

Ben Vandermeer

Affiliation: Biostatistician, Alberta Research Centre for Health Evidence, Department of Pediatrics, University of Alberta.

Research Interests: Meta-analysis and mixed treatment comparisons, RCT sample size methods, pediatric methods research, Bayesian statistics.

Current Projects: Researching effect of extrapolating nuisance parameters from adult to pediatric trials when computing sample sizes; Advancing methods in knowledge synthesis in pediatric systematic reviews; Quality assessment in pediatric systematic reviews.

Martin Offringa

Affiliation: Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada

Research interests: Design, conduct, and reporting of high quality trials that inform decision making.

Current projects: Developing standards, frameworks, and tools for ethics review of multicentre trials; deferring consent in trials in acute medical conditions (publication submitted); developing justifiable comparators to enhance recruitment; developing relevant, acceptable and responsive health outcomes for children.

Haroon Saloojee

Affiliation: Division of Community Pediatrics, Department of Pediatrics and Child Health, University of the Witwatersrand, Johannesburg, South Africa

Susan Ellenberg

Affiliation: Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania

Dirk Bassler

Affiliation: Center for Pediatric Clinical Studies and Department of Neonatology, University Children’s Hospital, Tuebingen, Germany

Lisa Askie

Affiliation: NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia

Douglas G. Altman ​†

 † Deceased 3 June 2018

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