The Crucial Role of the Biostatistician in a Clinical Trial

The goal of a clinical research study is to draw conclusions from evidence and reasoning, based on data collected from the patients in the study, and applying logic to make a judgment about how the findings of the study apply to the general public's needs.

From trial design to protocol development, Biostatisticians play a crucial role in upholding the integrity of a clinical trial by their involvement and their understanding of statistical issues.

As soon as the protocol and Case Report Form (CRF) have been finalized for a clinical trial research study, Pharmaceutical and Biotech clinical managers turn to a Biostatistics group to create a Statistical Analysis Plan (SAP).

Once the SAP is finalized, the biostatistics team will expand on the analyses and summaries mentioned in the plan, and will add more details on the derivations and assumptions being made. Tables, Listings, and Figures (TLFs) will begin to be formatted for data outputs.

The Biostatistics’ Group set the stage for the programming team, who refer to the SAP and TLFs to complete their job. For this reason, it is important for the statisticians to work closely together with the programming team early on in the project, conducting mutual reviews, and asking for confirmation from the programmers, to make sure the preliminary work makes perfect sense.

The role of the biostatistician extends to working with clinical operations, as well. It’s a critical role among the focused teams; namely, Clinical Operations, Data Management, and Programming, including the following considerations:

  • Input into the site and/or patient issues conducting ongoing reviews of the data, reviewing protocol amendments
  • Conducting sample size re-estimation when needed
  • Presenting data management questions
  • Preparing tables, listings, and figures before the database lock

Biostatisticians are essentially point persons for the pharmaceutical company, to ensure their clinical data will flow smoothly from the start of the trial, through to the end. Their role is as essential during monitoring activities, as it is in the beginning and closing stages. They are responsible for planning and monitoring interim analyses, and are tasked with the responsibility of assessing the safety and efficacy of the drug that is being studied.

The “close of the study” is a crucial part of the clinical process, and finds Biostatisticians on deck with 100% involvement. There is a special focus placed on the primary analysis write-up, and the conclusions drawn. Upon final analysis and database lock, Biostatisticians must draft the results and TLFs, obtain client feedback, and then provide final TLFs. All are typically completed within a month.

Job Responsibilities for a Biostatistics Department -

Leadership - Supervision, coordination, and organization of the biostatistics project team

Training - Project-specific training of biostatistics project team on timelines, budget, scope of work, executed contract, relevant SOPs and project-specific documents (e.g. study protocol, project plans, etc.)

Reporting & Delivery -

  • Responsible for project-specific status, quality, timelines, and budget within biostatistics
  • Responsible for on-time delivery of all contracted biostatistics related project tasks and deliverables, and in alignment with the executed contract, SOPs and project plan
  • Regular status update reports to PM and client
  • Proactive reporting & management of all project-related functional issues to PM

Strategy -

  • Support in the early planning of the project
  • Statistical consultancy, regulatory considerations, identification of appropriate statistical model, sample size calculation, and input in study outline
  • Support in preparation, review, and finalization of the clinical study protocol

SAP, CRF, TLFs, and CSR -

  • Preparation and finalization of the statistical analysis plan (SAP)
  • Review of CRF as the basis for the clinical database
  • Support in preparation, review, and finalization of the TLFs
  • Support in preparation, review, and finalization of the clinical study report

In conclusion, it is hard to imagine clinical trials moving forward without 100% immersed involvement of Biostatisticians. Their statistical strategy, monitoring expertise, and capacity for logical thinking and analyses are what give studies the structure and discipline needed for true outcomes. It is a focused and rewarding job to be a Biostatistician, and we salute their wonderful contributions to our well-being.