Clinical Epidemiology & Biostatistics (CEBU)
High-level expertise in data science underpinning evidence for better health in children and young people.
The Clinical Epidemiology and Biostatistics Unit (CEBU) specialises in biostatistics, epidemiological methods, and data management. With co-funding from the University of Melbourne, we provide expertise and support to all researchers on the Melbourne Children's campus.
We collaborate with a wide range of clinical and population health researchers and also conduct methodological research, both to develop and strengthen the biostatistical methods underpinning modern health research and to develop future leaders in data science.
Our research
The group’s work is important across many clinical and health problems, because almost all modern research involving patients and children relies heavily on statistical methods, in order to design high-quality studies and interpret the resulting data appropriately.
MCRI has developed a national profile in this area. We are a leading example of how internationally renowned biostatistical expertise can be developed and integrated with major health research programs.
Our group’s work on cutting-edge methods for handling missing data problems and modern causal inference has attracted international recognition.
Researcher training and tools
We are dedicated to promoting high-quality research standards. In partnership with the Melbourne Children's Campus, we offer offer clinical and public health researchers expert-led training, resources to support both new and established researchers in clinical and public health fields.
More on researcher training & tools
Contact us
Clinical Epidemiology & Biostatistics (CEBU)
Email:
show email address
Group Leaders
Team Leaders
Group Members
Our projects
Addressing new challenges with missing data in complex epidemiological studies: methods, guidance and software
This research program continues to add to knowledge and guidance on effective use of methods such as multiple imputation to handle missing data in health research. Katherine Lee, Margarita Moreno-Betancur, Cattram Nguyen and John Carlin.
Causal inference in health data science: advancing understanding and methods
This program of research aims to develop, disseminate and promote the adoption of modern causal thinking and related methods in medical and health research. Margarita Moreno-Betancur and John Carlin.
Australian Trials Methodology (AusTriM) Research Network
The AusTriM network brings Australia’s leading biostatisticians with expertise in trials together with investigators who conduct landmark trials to develop, evaluate and apply innovative approaches in design and analysis of clinical trials. Katherine Lee, Kaushala Jayawardana and John Carlin.
Melbourne Children's Trials Centre (MCTC)
In our role with the MCTC we work to design and analyse randomised controlled trials to address important questions about effectiveness of a wide range of clinical interventions, with researchers across the Melbourne Children's Campus. Major trials that we support include:
- BRACE Trial: BCG vaccination to combat COVID-19 (Principle Investigator Nigel Curtis)
- VITALITY Trial: Vitamin D to prevent allergy (Principle Investigator Kirsten Perrett)
- Strengthening Care for Children (Principle Investigator Harriet Hiscock)
- POLAR Trial: A randomised control trial of PEEP levels during resuscitation of preterm infants at birth (Principle Investigator David Tingay)
- TREX Trial: A comparison of long-term outcomes after two different anaesthetics (Principle Investigator Andrew Davidson)
- PEAT Study: Probiotic oral immunotherapy for the treatment of egg allergy (Principle Investigator Mimi Tang)
Lead researchers
Katherine Lee, Anneke Grobler, Francesca Orsini, Rachel Schembri, Kaushala Jayawardana and Xiaofang Wang.
Melbourne Children's Trials Centre
LifeCourse Initiative
We provide methodological leadership within the LifeCourse initiative, which is a hub for observational research grouping the over 40 clinical and population-based longitudinal cohort studies housed at the Melbourne Children’s.
Lead researchers: Margarita Moreno-Betancur and Marnie Downes, with David Burgner, Craig Olsson and colleagues.
Generation Victoria (GenV)
We provide high-level support with respect to research design and biostatistics to this major initiative to create a large state-wide cohort study of newborn children.
Lead researchers: John Carlin, Katherine Lee, Margarita Moreno-Betancur, with Melissa Wake and colleagues.
Centre for Adolescent Health (CAH)
We have a longstanding collaboration with CAH, providing support to two major longitudinal cohort studies: the Victorian Adolescent Health Cohort Study (VAHCS) and the Childhood to Adolescence Transition Study (CATS).
Lead researchers: Margarita Moreno-Betancur, Ghazaleh Dashti and John Carlin, with George Patton and colleagues.
Centre for Adolescent Health (CAH)
Neurodisability and developmental group
We provide statistical support to this group’s extensive range of studies into the causes and management of childhood disabilities.
Lead researchers: Margarita Moreno-Betancur and Daisy Shepherd, with David Amor.
Victorian Infant Brain Study (VIBeS)
Exploring long-term neurodevelopmental and health outcomes in very preterm babies and their families.
Lead researchers: Katherine Lee and Diana Zannino with Peter Anderson, Deanne Thompson and colleagues.
More on VIBeS.
Barwon Infant Study
A prebirth cohort study investigating the interplay between the modern environment and the early life origins of eczema, food allergy, asthma and atherosclerosis.
OPTIMIST Trial
A multicentre randomised controlled trial of minimally-invasive surfactant therapy in very preterm infants on continuous positive airway pressure.
OPTIMISM is a four-week study that aims to compare the effects of two dietary patterns on depressive symptoms and other outcomes including anxiety, microbiome composition, gut permeability, and inflammation among adults with and without depression.
PLUSS Trial: Preventing Lung Disease Using Surfactant + Steroid
A multicentre randomised controlled trial of surfactant plus budesonide to improve survival free of bronchopulmonary dysplasia in extremely preterm infants.
Lead researchers: Susan Donath with Omar Kamlin, Brett Manley and colleagues, Royal Women’s Hospital.
SONIC: Study of neck injuries in children
A large prospective observational study to develop a new or validate existing international clinical decision rules for children presenting to the emergency department with suspected cervical spinal injuries.
Completed projects
ViCBiostat: the Victorian Centre for Biostatistics, a Centre of Research Excellence in biostatistics
Originally funded by an NHMRC grant, ViCBiostat provided support for postdoctoral biostatisticians and PhD students working on a range of methodological research projects.
Lead researchers: John Carlin, Katherine Lee and Margarita Moreno-Betancur, MCRI, with Andrew Forbes, Rory Wolfe and Jessica Kazsa, Monash University, and Lyle Gurrin and Julie Simpson, University of Melbourne School of Population and Global Health.
Funding
Thank you to our supporters.
- National Health and Medical Research Council
- Australian Research Council
- Co-funding from the University of Melbourne
Collaborations
We partner with leading institutions worldwide, including:
- Professor Andrew Forbes, Professor Rory Wolfe & Dr Jessica Kasza, Biostatistics Group, Department of Epidemiology & Preventive Medicine, Monash University
- Professor Julie Simpson & Professor Lyle Gurrin, University of Melbourne School of Population & Global Health
- Dr Julie Marsh & Professor Steve Webb (Univ. of W.A.), Dr Lisa Yelland & Dr Tom Sullivan (Univ. of Adelaide) and other members of the Australian Clinical Trials Methodology network (AusTriM)
- Professor Ian White, MRC Clinical Trials Unit, University College London, U.K.
- Professor James Carpenter, London School of Hygiene and Tropical Medicine
- Professor Kate Tilling, University of Bristol
- Professor Stijn Vansteelandt, Ghent University, Belgium
- Professor Andrew Gelman, Columbia University, U.S.A.
Featured publications
Lee KJ, Tilling KM, Cornish RP, Little RJA, Bell ML, Goetghebeur E, Hogan JW, Carpenter JR; STRATOS initiative. Framework for the treatment and reporting of missing data in observational studies: The Treatment And Reporting of Missing data in Observational Studies framework. J Clin Epidemiol. 2021 Jun;134:79-88. doi: 10.1016/j.jclinepi.2021.01.008. Epub 2021 Feb 2. PMID: 33539930; PMCID: PMC8168830.
Moreno-Betancur M, Moran P, Becker D, Patton GC, Carlin JB. Mediation effects that emulate a target randomised trial: Simulation-based evaluation of ill-defined interventions on multiple mediators. Stat Methods Med Res. 2021 Jun;30(6):1395-1412. doi: 10.1177/0962280221998409. Epub 2021 Mar 20. PMID: 33749386; PMCID: PMC8371283.
Dargaville PA, Kamlin COF, Orsini F, Wang X, De Paoli AG, Kanmaz Kutman HG, Cetinkaya M, Kornhauser-Cerar L, Derrick M, Özkan H, Hulzebos CV, Schmölzer GM, Aiyappan A, Lemyre B, Kuo S, Rajadurai VS, O'Shea J, Biniwale M, Ramanathan R, Kushnir A, Bader D, Thomas MR, Chakraborty M, Buksh MJ, Bhatia R, Sullivan CL, Shinwell ES, Dyson A, Barker DP, Kugelman A, Donovan TJ, Tauscher MK, Murthy V, Ali SKM, Yossuck P, Clark HW, Soll RF, Carlin JB, Davis PG; OPTIMIST-A Trial Investigators. Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome: The OPTIMIST-A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2478-2487. doi: 10.1001/jama.2021.21892. PMID: 34902013; PMCID: PMC8715350.
Moreno-Betancur M, Lee KJ, Leacy FP, White IR, Simpson JA, Carlin JB. Canonical Causal Diagrams to Guide the Treatment of Missing Data in Epidemiologic Studies. Am J Epidemiol. 2018 Dec 1;187(12):2705-2715. doi: 10.1093/aje/kwy173. Erratum in: Am J Epidemiol. 2025 Mar 4;194(3):877-880. doi: 10.1093/aje/kwae406. PMID: 30124749; PMCID: PMC6269242.
Roberts CT, Owen LS, Manley BJ, Frøisland DH, Donath SM, Dalziel KM, Pritchard MA, Cartwright DW, Collins CL, Malhotra A, Davis PG; HIPSTER Trial Investigators. Nasal High-Flow Therapy for Primary Respiratory Support in Preterm Infants. N Engl J Med. 2016 Sep 22;375(12):1142-51. doi: 10.1056/NEJMoa1603694. PMID: 27653564.
McNab S, Duke T, South M, Babl FE, Lee KJ, Arnup SJ, Young S, Turner H, Davidson A. 140 mmol/L of sodium versus 77 mmol/L of sodium in maintenance intravenous fluid therapy for children in hospital (PIMS): a randomised controlled double-blind trial. Lancet. 2015 Mar 28;385(9974):1190-7. doi: 10.1016/S0140-6736(14)61459-8. Epub 2014 Dec 1. PMID: 25472864.