Biomedical statistics
Statistical analysis is a key stage in the clinical study process. The significance of a biomedical statistician’s contribution is shown during the initiation of the trial, during the formation of the hypothesis, design development and sample size calculation, and during the analysis of collected data.
Regulatory requirements for statistical handling within clinical trials are becoming more rigorous and errors during the planning stage, such as an incorrect hypothesis or sample size can undermine the result accuracy.
The sample size directly affects the outcome of the study, as well as its cost and duration. Different wordings of hypotheses and calculation methods can produce completely different results.
When it’s scientifically valid, our experts can offer studies that feature an adaptive design, which allows to reduce group sizes, as well as research costs and duration.
An adaptive study design assumes the possibility of altering design elements based on interim data, such as inclusion criteria, randomization procedures, sample size, clinical strategies, procedure schedules, additional therapies, final points and statistical analysis methods. Examples of such adjustments include a review of the sample size based on interim data analysis and combined phase II-III studies.
The statisticians' duties begin with developing the study protocol synopsis, where various experimental scenarios are predicted based on literary data.
After the Sponsor approves the protocol, a statistical analysis plan is developed, which describes all statistical data management procedures in detail, including work with software, variables, deviations, outliers and define comparison and assessment methods.
Before closing the database, the statisticians verify that the data is in accordance with the statistical analysis plan, and after the database is closed, conduct the analysis and forms a statistical report, which includes analytical and descriptive sections.
Depending on our clients’ demands, we use software packages such as SAS/STAT®, Statistica®, R and Pass 13 for our calculations and modelling.
We offer the following services:
- Defining the hypothesis and final study points
- Developing the study design
- Calculating the sample size
- Preparing randomization lists
- Developing the statistical analysis plan
- Statistical analysis and data interpretation
- Compiling interim and final statistical reports
The statistical report is then passed onto the medical documentation department to form the final clinical study report.