The Role of Biostatisticians in Clinical Research

Statistics play a crucial role in clinical trials and in the drug development process – from trial design to protocol development. Having a fundamental understanding of statistical issues can uphold the integrity of a clinical trial and improve communication between clinicians and statisticians.

As a clinical trial professional, non-statistician, are you familiar with the following statistical concepts?

  • Confidence Intervals
  • Multiplicity
  • Subgroup Analysis
  • Parametric vs. Non-parametric statistical methods
  • Sample Size Calculation
  • Types of endpoints
  • Statistical Reporting
  • Missing Data
  • Adaptive Trial Design
  • Bayesian Model

Biostatistics are involved in every step of clinical research including trial design, protocol development, data management and monitoring, data analysis and clinical trial reporting. A Harvard report on clinical research demonstrated evidence that suggests that researchers often misinterpret statistical methods due to poor knowledge of statistical concepts.

Statisticians and clinical operations personnel must always communicate in order to ensure successful trial design and analyses. A factor that can often hinder effective communication is complicated statistical terminology. Since statisticians can specialize in study designs (even complex designs like Adaptive Trial Design), therapeutic areas and statistical methods, it is crucial that the rest of the study team understands the statistical strategy proposed by the biostatistician.

Why is it so important to understand the role of the biostatistician?
How well do you understand the statistical elements in these areas of clinical research?

  • Protocol Development & Design
  • Data Management
  • Study Implementation
  • Study Monitoring
  • Data Analysis & Reporting

The biostatistician works closely with the rest of the biometrics team and management throughout the study including Data Managers, Statistical Programmers and Medical Writers. Regarding Data Management, the biostatistician can assist with CRF development and dataset specifications. Working with statistical programmers, methodological biostatisticians ensure data formatting is correct and select data to be pooled. In terms of medical writing, biostatisticians will often write the statistical part of the Clinical Study Report.

In the Statistical Analysis Plan (SAP), the biostatistician will outline study endpoints, sample size calculation, interim analysis planning and the hypothesis and testing procedures. Perhaps the most well-known responsibility of the biostatistician is the definition of sample size which involves several factors that influence the size of the study, timelines and budget requirements.

Therefore, how well do you really understand these concepts when it comes to evaluating clinical research results?