George Clinical’s statistics experts analyze and design clinical trials across a broad range of therapeutic areas.
The George Clinical statistics team has extensive experience in the design and analysis of clinical trials, including adaptive designs. Our statistics team are familiar with a wide range of therapeutic areas, including, but not limited to: Oncology, Cardiology, Neurology, Respiratory, Nephrology, Endocrinology, Pain Control, Infectious Diseases, Critical Care, Substance Abuse and a diversity of Medical Devices.
George Clinical’s experience includes complex clinical trials using cluster, cluster-crossover, and stepped-wedged designs. The statistical team also supports a range of other research projects (complex surveys, longitudinal studies, risk score development) and provides general advice and training. The team has the capacity to execute an innovative statistical research program aimed at addressing methodological problems relevant to our research.
George Clinical designs studies that meet a sponsor’s specific research objectives and will compare the feasibility of alternative designs to maximize the return on the sponsor’s research investment.
George Clinical provides complete protocol development services. With the provision of basic research concepts or background documents, George Clinical can develop a high quality draft protocol, revised with input from the sponsor and key opinion leaders, and then finalize a protocol suitable for submission to institutional review boards.
George Clinical provides statistical review of protocols, case report forms (CRF), and other study documents. Review of these protocols include consideration of the appropriateness of the statistical content, including the consistency of objectives with study measures and planned analyses. This also includes evaluation of the completeness and quality of statistical content.
The review of CRFs entails the matching of CRF content to protocol and/or statistical analysis plans. It also includes evaluation of the nesting structure of the data as implied by the CRF.
By request, George Clinical can produce random allocation sequences for multiple group designs, with specified proportions assigned to each group, and with the number of stratification variables allowed by sample size.
George Clinical can produce or assist in the production of statistical analysis plans (SAPs) for all our studies, irrespective of complexity. Typical SAPs are free-standing documents with abbreviated study background, a complete description of raw and derived variables, and specifications for all descriptive and inferential procedures that are to be conducted. The SAP also specifies scheduled interim and final analyses by accrual or calendar schedule, the assessment points (for repeated measures) and the cohorts to be included in each analysis. For intervention studies, the SAP generally includes table shells, definition of figures to be generated, and listings to be produced (TFLs). For oncology observational and retrospective research, TFLs generally include labeling and description of tables without production of table shells.
George Clinical has expertise in the application of a wide range of statistical methodologies that include:
George Clinical can implement analyses appropriate to most research study designs, including single and multiple arm intervention studies. George Clinical will also interpret statistical findings for all these methodologies.
George Clinical can provide sample size estimation or statistical power analyses that account for the design and effect size assumptions of most research studies. This includes one or two arm studies, single stage and two stage designs, and those using continuous, binary, and censored endpoints.
George Clinical provides consultation services related to a range of statistical activities. These include consultation regarding study design and analysis planning for intervention trials, prospective observational research, and retrospective studies. George Clinical also provides consultation regarding development of random allocation sequences, and strategies for balancing in non-equivalent control group designs.
We support clinical trials and other research projects from conception to publication. All the analyses use up-to-date and validated software (eg. SAS and Stata for statistical analyses, PASS for sample size calculations) and are performed to ICH GCP standards with emphasis on validation, traceability and reproducibility.
Our Statistics experts deliver:
Our statistics team operate globally. Our statistics experts analyse and design clinical trials across a broad range of therapeutic areas. To see the breadth of our networks in each therapeutic area, please click on the below links:
Stephen Jan is Head of the Health Economics and Process Evaluation Program at the George Institute for Global Health and Professor, Faculty of Medicine, UNSW Sydney.
He is an Honorary Professor at the University of Sydney, a Director of the Sax Institute and an Associate at both the Menzies Centre for Health Policy and the Poche Centre for Indigenous Health. He is a current NHMRC Principal Research Fellow and has previously held posts at the London School of Hygiene and Tropical Medicine and the Centre for Health Economics Research and Evaluation (CHERE) in Sydney. Stephen has over 20 years of experience in health economics, has published over 200 scientific articles and authored two textbooks in health economics.
He has worked closely with various governments of different levels, both in Australia (Commonwealth and State) and overseas, with international agencies such as the WHO and industry. His areas of expertise are economic evaluation, health financing, health sector priority setting, Indigenous and global health issues and the economics of chronic disease.
Laurent is a senior biostatistician with 20 years of experience in health research. He is Director of the Statistics Division at the George Institute for Global Health and Associate Professor, Faculty of Medicine, UNSW Sydney.
He is responsible for providing statistical services to the George Institute and its collaborators in Australia and globally. He holds a Master of Science in Statistics and Computer Science and a Master of Research in Public Health (Biostatistics). He is an accredited statistician by the Statistical Society of Australia (AStat).