Data is the heart of your clinical trial, and it is vital that it is handled appropriately. Having a deep understanding of the trial ensures the statistical analysis, interpretation, and reporting is clear, reducing the likelihood of regulatory delays. Datapharm's experienced statisticians and medical writers are involved at all stages of a clinical trial project to ensure this.

The statistical methodology is detailed clearly in the statistical analysis plan (SAP) and collectively agreed upon by Datapharm and sponsors. This ensures transparency of the statistical methodology and to agree that it adequately addresses the study objectives.

Data analysis can be descriptive or inferential, aiming to parse the data and deliver high-level information to readers. Ad-hoc analyses can also be performed if justified, based on any interesting or unexpected patterns that appear in the data or results. 

Interim analyses may be needed for DSMB meetings and adaptive study designs, providing insight into the current body of results and potentially guiding the rest of the study.

ICH guidelines specify that clinical trial tables and listings should adhere to a pre-specified format to suit inclusion in the clinical study report (CSR). In addition to presenting tables, figures, and listings to global regulatory standards, we can also present findings in other formats such as short summary tables with key information for powerpoint presentations.

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5 Takeaways: Statistical analysis

  1. Datapharm's statisticians are experienced in providing clear, concise interpretation of complex statistical results to tell the story of your data.
  2. The statistical analysis plan details the statistical methodology to address the study objectives.
  3. The choice of statistical tests depends on a myriad of factors, including but not limited to the study aims, the dependent and independent variables, and data availability.
  4. The clinical study report (CSR) is a document produced at the end of the study detailing the results.
  5. Results and listings are formatted and presented in a fashion that meets global regulatory standards.


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