Clinical Trials
The statistical foundations of a trial, from allocation and sample size through to the final analysis.
A trial’s conclusions rest on decisions taken long before the data arrive. We support trials of all phases, from design through to the manuscript support. We also have expertise to support studies with advanced study design such as stepped-wedged design, adaptive designs, master protocols and pragmatic trials.
How we support your trial
Study design and protocol development
Designing clinical trials by contributing the statistical blueprint for answering research question, including the randomisation scheme, statistical analysis plan, and sample size determination with underlying assumptions, as well as review of protocol amendments.
Sample size determination and re-estimation
Calculate and, where appropriate, re-estimate the sample size based on stated assumptions and justifications, such as the target (or clinically meaningful) effect size and the expected variability.
Randomisation system
Generation of randomisation lists, including advanced features such as stratified blocked randomisation, minimisation, and adaptive-response methods; processes for validation, audit trail maintenance, secure access control, and documented change.
Case report form and database review
Review of case report forms, in printed or electronic form, and of the database design, before data collection starts to minimise data cleaning and ensure all planned data points are collected.
Statistical analysis plan (SAP)
A full analysis plan for the trial, with mock shells for the planned tables, figures and listings, so that what will be produced is agreed before any analysis begins.
Data and Safety Monitoring Board (DSMB) support
Developing and reviewing the DSMB charter, preparing the mock shells and outputs for closed-session interim analysis reports, and serving as DSMB members.
Interim analyses
Analysis dataset specification and programming for planned interim analyses.
Final analysis
Analysis dataset development and validation, and analysis programming carried out as specified in the statistical analysis plan.
Secondary analysis of trial data
Planning, analysis and manuscript support for questions taken up after the primary analysis is complete.
Reporting and publication support — statistical analysis reports, clinical study report sections, and manuscripts — is described under Project Collaboration.
Our experience
Our Biostatistics team has supported clinical research across specialties including oncology, diabetes, cardiovascular disease, infectious disease, and eye care. The team has a strong track record of enhancing the quality and reproducibility of evidence, enabling practice-changing research and evidence-based patient care. Our statisticians are regularly invited to review grant applications, journal manuscripts and conference abstracts — so we know what reviewers look for and what causes proposals to fall short. The team has supported more than 150 studies, 150 grant proposals, and 200 research papers.
Our work in practice
ASCOLT - Our Biostatistics team supported the ASCOLT (Aspirin in Dukes C and High Risk Dukes B Colorectal Cancer) trial for over 10 years by providing critical study design, developing randomization infrastructure, interim reporting to data and safety monitoring board (DSMB), performing complex survival data analysis, and ensuring high-quality reporting. The main paper was published at The Lancet Gastroenterology & Hepatology (opens in new tab).
COBRA-BPS - The COBRA-BPS (Control of Blood Pressure and Risk Attenuation) trial was a multi-country trial which used a cluster-randomized design across rural communities in Bangladesh, Pakistan, and Sri Lanka to evaluate a community health worker-led hypertension multi-component intervention of home health education, blood pressure monitoring, provider training, and clinic care coordination. Our Biostatistics team supported the study by providing advanced study design, developing randomization infrastructure, interim reporting to data and safety monitoring board (DSMB) and statistical analysis plan (SAP) development. The paper was published at The New England Journal of Medicine (opens in new tab).
TRUNCATE-TB - This non-inferiority adaptive trial, which was sponsored by University College London and supported by The International Union Against Tuberculosis (TB) and Lung Disease, evaluated an alternative strategy of treating patients with drug-sensitive tuberculosis (DS-TB) for 2 months with combinations including new drugs or optimised doses of currently available drugs, chosen for their sterilising efficacy. Our Biostatistics team provided critical biostatistical, randomisation development, and complex data analytics. The main paper was published at The New England Journal of Medicine (opens in new tab).
AHCC06 - This was a large-scale, Asia–Pacific, multicenter, phase III study comparing selective internal radiation therapy with sorafenib in advanced hepatocellular carcinoma. Our Biostatistics team supported trial design and planning, facilitated independent data and safety monitoring board (DSMB) reviews (including conducting rigorous interim analyses), and performed final statistical programming and analysis that led to presentations at major international oncology meetings like ASCO. The main results of this trial were published in the Journal of Clinical Oncology (opens in new tab).
Engaging us
The earlier we are involved, the more we can help. To discuss a trial, contact us via email: contact@scri.cris.sg
Related pages: Project Collaboration · Grant Application Collaboration · Consultancy Services