Biostatistics Platform

Biostatistics Platform provides expertise in the data, quantitative, and statistical aspects of clinical research carried out at the Department of Obstetrics and Gynaecology.

About Biostatistics Platform

The primary goal of the Biostatistics Platform is to support clinical researchers. To achieve this, we collaborate with the Department researchers to provide expert assistance with research study design and analysis, and advise on data management issues through all phases of a research study – from formulating a research plan and a study protocol to writing up the results. We also act as a conduit for a range of training and development opportunities in the areas of study design and statistical analysis.

What we do

We collaborate on, and provide advice and consulting services regarding:

Statistical and design aspects of:

  • Protocol development
  • Ethics application development
  • External bodies funding application development
  • Presentations and writing up of results
  • Development of statistical analysis plan

Study design:

  • Refinement of research hypotheses and questions
  • Selection of appropriate outcome measures and measurement scales, stratification, and blocking mechanisms
  • Effect size elicitation from the literature through meta-analysis
  • Power analysis and sample size calculations
  • Creation of randomisation schedules

Statistical analysis:

  • Analysis planning
  • Statistical analysis
  • Programming of tables, listings and figures
  • Analysis services to Data Safety Monitoring Boards, including conducting interim analyses and statistical monitoring

Advice on data-related issues:

  • Specification and validation of data structures and data handling procedures

What we do not do:

Trial registration

Questionnaire development

Data management:

x Design and maintenance of databases, electronic case report forms, and data entry screens

x Validation/Consistency check programming

x  Development and Validation of Data Management Plans

x  Data capture and cleaning

x Creating data sets from scanned forms

How we operate

When to involve us

We prefer to be involved in projects early, so that we participate in as many aspects of the research design and conduct as possible. We both preach and practice the idea that the experts in design and analysis should be at the genesis of projects- serving as the research project’s ‘midwives’, not their ‘post-mortem analysts’! Most importantly, we believe that there is a big difference between the Biostatistics platform and a Rapid Response Unit or a Fire Brigade. If you have a deadline, please discuss this with us well in advance.

Initial consultation

In order to organise an initial consultation, please:

  1. Send an email to Biostatistics Platform with the subject line “Initial statistical consultation request.”
  2. Include a brief summary of your project (Max 250 words).
  3. Make sure that you secured the support from you Department Head/Lab Head and include a statement for such support in your email, e.g. “This project has the support of my Department/Lab Head.”
  4. Answer the applicable questions in your email:
  • Is the project being run as part of the work you do at the Dept of O&G?
  • Do you have a salaried position within the Dept of O&G?
  • Are you a student enrolled through the Dept of O&G?
  • If you are an honorary staff member, is the project you are requesting assistance with held within the Dept of O&G?

We will get back to you usually within 48-72 hours to organise the consultation.

Intellectual contribution and co-authorship

If we make an intellectual and scientific contribution to the project, then co-authorship of resulting papers is appropriate. The way we operate on this issue is based on The Australian Code for the Responsible Conduct of Research (NHMRC, 2018):

  • To warrant a co-authorship, it requires a substantial contribution to the work in a combination of conception and design of the project, analysis and interpretation of research data, and drafting significant parts of the work or critically revising it so as to contribute to the interpretation;

Training and development opportunities

More information and resources on this topic relevant for Department of Obstetrics and Gynaecology can be found on Biostatistics Platform Resources page.