Alongside data managers, statistical programmers and medical writers, biostatisticians play an integral role in the collaborative effort to develop new drugs and devices. And that’s because biostatisticians are involved in every step of clinical research – from study design to protocol development to data management and monitoring to data analysis and clinical trial reporting to regulatory submission.
But what exactly do biostatisticians do?
First, they must get up to speed on the study. To contribute to the development and design of a trial protocol, a biostatistician engages with the clinical team, conducts literature reviews – including guidelines from regulatory authorities – and explores pilot data.
Armed with this knowledge, a biostatistician advises the clinical team on primary and secondary endpoints and determines the sample size of a study, which involves several factors that ultimately influence the size of the study, timelines and budget requirements. The biostatistician writes the statistical section of the protocol, including details on randomization and blinding, sample size justification, and the methods used for statistical analysis of the endpoints. Once the protocol is finalized, the biostatistician develops a statistical analysis plan (SAP), which provides more details about the interim analysis (if applicable), the statistical methods for each of the primary and secondary endpoints, and any planned sensitivity analysis to address missing data.
Once the protocol is finalized, the biostatistician reviews the CRF with the data management team to make sure that the study data is captured in a format that enables an efficient, effective and reliable analysis process, and that all the data needed to support the primary and secondary endpoints are included. While the study is ongoing, the biostatistician works with the data managers to perform high-level data reviews, identifying inconsistencies and potential issues with outcome data that could impact the analysis. When risk-based monitoring (RBM) is implemented to streamline data reviews, the biostatistician defines the parameters for this clinical trial-monitoring technique, which employs various tools, platforms and dashboards to identify signals that indicate potential issues with trial conduct, safety, data integrity, compliance and enrollment, among other risk areas. This allows the study team to fulfill regulatory requirements, concentrate on high-value tasks and focus resources where they are most needed, while moving away from 100% source data verification (SDV) of patient data. Interim safety reports for data safety monitoring boards, as well as any interim efficacy analysis are produced by the unblinded statistician together with the statistical programmers and the clinical team.
At the end of the study, before locking the database, the biostatistician and data managers conduct a thorough data review. They also conduct data analysis as specified in the SAP, as well as sensitivity analysis to address situations in which data is missing. With the medical writers and the clinical team dedicated to the study, the biostatistician summarizes the results and helps to interpret them. The biostatistician plays a key role in drafting and collaborating with the medical writers to produce the clinical study report. When study findings are published in peer-review journals, the biostatistician outlines the statistical methods and results, and reviews the paper for consistency. Furthermore, the biostatistician takes a lead role in preparing submissions to regulatory authorities such as the FDA and EMA, and participates in meetings with them throughout the study program.
Given the multifaceted role they play in clinical research, it’s best to involve biostatisticians at the beginning of the protocol development stage. Doing so ensures that the trial is well designed by taking into account regulatory requirements, monitored effectively and that the study results are analyzed and interpreted correctly.
At BioForum, our dedicated biostatisticians partner with sponsors to conduct studies across all phases of clinical trials. They also guide observational studies, analyzing data that have already been collected outside the context of a clinical trial. With our team of world-class biostatisticians, we have the capabilities to assist with clinical trial design, write the statistical sections of protocols with the corresponding statistical analysis plans, and expertly perform the statistical analysis necessary to successfully submit your trial to regulatory authorities.