Why Biostatistics Are Essential for Clinical Trials
January 24, 2025Clinical trials are at the heart of advancing medical research and bringing new therapies, treatments, and medical devices to market. At Atlantic Research Group (ARG), we understand that the success of these trials depends not only on rigorous study design and patient recruitment but also on a key component that is often behind the scenes: biostatistics and statistical programming. Without it, the validity of the trial outcomes could be questioned, making it an indispensable part of clinical research. We recently sat down with ARG’s Director of Data Informatics, Hali Beeson to unpack the ‘hows’ and ‘whys’ behind biostatistics.
What Is Biostatistics?
Biostatistics combines the fields of statistics and biology to make sense of complex data arising from clinical trials. It involves designing the study, choosing appropriate sample sizes, determining the methods of data collection, and analyzing the results. Biostatisticians work hand-in-hand with clinical researchers to ensure that the data generated are valid, reliable, and robust, thus providing a solid foundation for evidence-based medical decisions.
“How I explain it to most people when I get asked what I do for a living is by putting it into perspective I feel most everyone can relate to,” Beeson said. “I explain that we do the analysis that people might hear regarding a new drug in ads and TV commercials. When the ads/commercials indicate that a percentage of people saw X, Y, or Z results or had X, Y, or Z side effects, we’re the department that comes up with those numbers."
Ensuring Study Design Integrity
A well-designed clinical trial is crucial for its success, and biostatistics plays an important role in structuring this design. Biostatisticians like Beeson and her team help to create protocols that ensure trials are scientifically valid while also being ethical. They determine the appropriate study population, randomization methods, and endpoints to make sure that the results are unbiased and replicable.
Due to the close nature of the ARG biostatistics team, they’re able to collaborate with ease from start to finish when needed.
“We are a unique department when it comes to Biostatistics,” Beeson noted. “Our Biostatisticians program works alongside our programmers. Our collaborative approach allows our clients to have a wealth of experience and knowledge from the entire department, not just the assigned study team. We've also worked together the majority of our careers.”
By doing this, biostatistics ensures that the study design eliminates confounding variables and other potential biases, giving the trial its best chance at producing meaningful and accurate results.
For example, biostatistics helps to establish clear collections of data, especially critical data necessary for the analysis of key endpoints. This precision helps streamline the trial and makes the findings more robust. As Beeson said, the day-to-day can look different depending on needs.
“The key parts that those in clinical research are most aware of regarding Biostatistics are the CDISC-compliant data sets, which are your SDTM and your ADaM datasets. These are required for submissions to the FDA. So, while Biostatistics and analysis are not often thought about in study start-up as they typically occur at the end of the study, we jump in right from the start. We aid Data Management in EDC build ensuring that all data, especially data for critical endpoints, is collected in a manner that will flow into CDISC-compliant datasets and is analyzable.
“Also, at the beginning of a study, we're going to be involved with external vendors and RTSM set up aiding with vendor agreements, and ensuring that the data transferred to us from the labs is compliant and complete. Another thing that makes ARG Biostatistics unique is our extensive experience with RSTM. I have personally worked with many different platforms, and while it may sound like a made-up number, I can honestly say I’ve created over 1000 randomization lists. This expertise gives us the capability to ensure our clients have the utmost confidence in this crucial piece of the study setup.”
Managing Data Quality and Consistency
Clinical trials generate vast amounts of data, from patient outcomes and side effects to biomarkers and diagnostic tests. Ensuring that this data is consistent and of high quality is critical for the success of the trial. Biostatistics provides the methodologies to clean, organize, and validate this data.
The consistency of data across different sites, patient populations, and time points can make or break a trial. Biostatistics enables the detection of outliers, missing values, and inconsistencies in the data that could compromise the study’s integrity. This approach allows for the identification of data trends and patterns that are essential for understanding the treatment’s efficacy and safety.
Analyzing Results
Once the data has been collected, biostatistics analyzes the results and draws meaningful conclusions. This analysis involves but is not limited to, comparing the treatment group with the control group, assessing differences in outcomes, and determining whether these differences are statistically significant.
The role of biostatistics in this phase is not just to produce numbers but to translate them into actionable insights. The biostatistical analysis can reveal whether a new drug is more effective than the current standard of care, whether there are any unforeseen risks, or whether a treatment has no discernible effect. These insights are essential for regulatory submissions, guiding the decision-making process for approval by bodies such as the FDA or EMA.
Supporting Regulatory Submissions
Biostatistics also plays a critical role in the regulatory approval process. Regulatory agencies require a comprehensive statistical analysis of trial data to assess the efficacy and safety of new treatments. Biostatisticians not only provide detailed reports, figures, and analyses that support these submissions and answer any questions from regulators but are critical in writing protocols and designing studies to help our clients achieve success. Clear, accurate biostatistical reporting helps regulators understand the significance of the findings and makes the case for why a new therapy should be approved for market use. Without biostatistics, the trial data would be insufficiently analyzed, which could delay or even prevent the approval of potentially life-saving treatments.
Submitting these reports without a biostatistics background can be a challenge. The biostatistics team at ARG aids clients with regulatory submissions and interactions as statistical consultants to ensure proper handling of the submissions. This removes the guesswork and streamlines the process.
Conclusion
Biostatistics is a pillar of clinical trials in the planning and protocol development stage, as well as the overall study and program planning. It ensures that the data generated is accurate, reliable, and meaningful, ultimately guiding the development of new treatments and therapies. At Atlantic Research Group, we recognize the importance of biostatistics, and that’s why we assist our clients every step of the way. By using advanced statistical methods, biostatistics turns complex clinical data into clear, actionable insights that drive medical progress forward.
