The biostatistician plays a crucial role in the drug and device development process – from protocol development to data analysis and regulatory submissions. We look at how the statistician is involved from study set-up through to analysis and why it is important for other clinical trial professionals to understand the role statisticians play in the overall clinical data strategy.
It is generally agreed that the best time to involve a biostatistician in a clinical study is from the very beginning. This allows the biostatistician to understand the study design and make suggestions on hypothesis testing and analysis and also ensures continuity throughout the study team.
The biostatistician plays a crucial role in the following areas:
- Protocol Development & Design
- Data Management
- Study Implementation
- Study Monitoring
- Data Analysis & Reporting
Protocol and Study Design
In the early stages of clinical development, the biostatistician is involved in defining study objectives and the appropriate study design and statistical method which is crucial for success.
The biostatistician is also responsible for defining study endpoints, sample size calculation, interim analysis monitoring plans and the hypothesis and testing procedures which are defined in the Statistical Analysis Plan (SAP). In each of these responsibilities, the biostatistician has additional considerations – for example, the biostatistician must decide if there should be multiple endpoints.
Perhaps the most well-known responsibility of the biostatistician is the definition of sample size. A good statistician will be able to calculate a sample size which keeps the study from becoming too large and fits within the study’s timelines and budget constraints. If the sample size is too small, the study may produce insignificant results. And if the sample size is too large, time and money are wasted to reach a conclusion.
Monitoring for Safety and Efficacy
The biostatistician is essential during monitoring activities and is responsible for planning interim analyses to assess the safety and efficacy of a drug in development. An interim analysis requires the study team biostatistician and an independent statistician to conduct unbiased analysis.
Centralized Statistical Monitoring – part of the Risk-Based Monitoring Strategy
With the aid of an algorithm tool, statisticians can define the risk areas and relevant thresholds. When the latest data is run through the algorithm, the statistician can compare the distribution of all variables in each investigative site with other sites, enabling abnormal data patterns to be detected. By analyzing all available information, CSM detects fraud and erroneous data by identifying the lack of variability or implausible values that go undetected using other approaches.
The biostatistician works closely with the rest of the biometrics team throughout the study including Data Managers, Statistical Programmers and Medical Writers. Regarding Data Management, the biostatistician can assist with CRF development and dataset specification. Working with statistical programmers, methodological statisticians ensure data formatting is correct and select data to be pooled.
CROS NT – Biostatistics and Statistical Consultancy
CROS NT has an expert team of biostatisticians with a range of experience, from the planning and design of a trial, to reporting and regulatory submission guidance. Our biostatisticians also provide consultancy on a case by case basis in the following areas:
- Protocol Design & Methodology
- Adaptive Trial Design & Bayesian Framework
- Making sense of clinical data: data mining, reporting
- Special considerations in oncology trials
- Support at DSMB meetings and meetings with regulatory agencies
- Risk-Based Monitoring