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, Medical Devices, Cardiology; Neurology, Respiratory, Renal, Endocrinology, Pain Control, Infectious Diseases, Critical Care, Substance Abuse.
This 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 medical research.
Statistical Analysis: Study Design
George Clinical designs studies that meet our sponsor’s specific oncology focused 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, revise with input from sponsor and key opinion leaders, and then finalize a protocol suitable for submission to institutional review boards.
Protocol and CRF Review
George Clinical provides statistical review of oncology 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 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 produces 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.
Analysis Plan Development
George Clinical can produce or assist in the production of statistical analysis plans (SAP) 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 labelling and description of tables without production of table shells.
Analysis and Interpretation
George Clinical has expertise in the application of a wide range of statistical methodologies used within our oncology programs, these include:
- Descriptive analysis of continuous, count, categorical, and censored outcomes
- Comparison of group means (univariate, multivariate, and repeated measures analysis of variance)
- Multiple linear regression
- Multiple binary and multinomial logistic regression
- Ordinal regression
- Linear mixed models for assessment of longitudinal data
- Nonparametric, parametric, and semi-parametric survival analysis methods
- Covariance structure modelling, including path analysis and latent variable modelling
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.
Sample Size Calculation
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 oncology 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:
- Study design and protocol review
- Sample size and power calculations
- Statistical analysis plan
- Data Safety Monitoring Board (DSMB) support
- Interim analyses
- Statistical programming and validation
- Reports and scientific publications
Our Statistics team operate globally and have unique expertise in Australia China, India, Japan, Korea, Hong Kong, New Zealand, and Malaysia.
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 below links: