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Throughout the planning, execution, and reporting of clinical trials, biostatistics is crucial. Biostatistics is now much better understood and appreciated than in previous years. In addition to being in charge of the quantitative aspects of clinical trial designs and the analysis of trial data, biostatisticians are regarded as essential members of the clinical teams who contribute to strategic discussions and help resolve day-to-day problems with studies and clinical programs.

What is Biostatistics?

The practice of collecting, organizing, and interpreting data has been part of statistics for decades. Since then, statistics have been used to create designs, understand relationships, and more. Biostatistics is one of the new statistical techniques that have emerged over time. It is the application of quantitative statistical tools in the areas of medicine, biological experimentation, and data collection, followed by analysis and interpretation of relationships with those data.

Role of Biostatistics in Clinical Trials

Biostatistics, in general, assists in collecting, analyzing, and presenting the data, just like any statistical tool. In clinical trials, biostatics supports decision-making regarding the drug’s safety, number of participants, etc. Among the other uses, it is also used to assess how effectively a treatment works.

Providing insight into sample size & implication of p-value: The size of the sample is an essential consideration in clinical trials. Biostatistics is crucial in this situation. Inaccurate calculations could result in a sample of quantitative research that is unable to identify the relationship between the predictor and the outcome variables.

Here is where the p-value comes into play to determine whether or not your results are significant. We might think of the p-value as a forerunner that evaluates our findings. If the p-value is 0.05 or less, the result is deemed as significant; however, if it is more than 0.05, the result is non-significant and is frequently overlooked.

What Exactly the Biostatisticians do in Clinical Trials?

The biostatisticians play a major role throughout the clinical trials, right from the developmental stage to the production of the results stage. We have described below what exactly the biostatisticians do in each stage for a better understanding of why biostatisticians are in high demand for clinical trials.

Planning and Study Design

The feasibility and relevancy of the study are evaluated as the initial step in this phase. The clinical research team and the biostatisticians collaborate closely to develop the objectives, measures, and hypotheses of the study. They identify the statistical challenges that might have an impact on the study’s design and choose the right sample size. Biostatisticians determine the bare minimum of participants required to identify a clinically significant difference among the control and treatment groups using the power of statistical calculations.

Randomization and Blinding Procedures

The crucial task of creating complex randomization and blinding processes for the clinical trial falls to biostatisticians. Randomization assures that participants are assigned fairly to the treatment and control groups. It is crucial to do accurate randomization because the success of the experiment as a whole may depend on it. The validity and reliability of the study’s findings may be compromised by improper randomization, which can also introduce bias. Similar to this, blinding techniques are crucial to preserving the trial’s integrity because they make sure that both those participating and the investigators are oblivious to the treatment allocations. By doing so, bias is prevented, and the outcomes observed are guaranteed to accurately reflect the effectiveness and safety of the intervention under examination. Biostatisticians add to the overall credibility and reliability of the study by carefully addressing these factors.

Trial Responsibilities

The biostatistician will undertake quality control tests to identify data outliers and assure the accuracy of the data at the final stage of the study once the data management team finishes collecting the data. This will guarantee that the data is of the highest standard and that there are no errors or anomalies. Additionally, throughout the course of the experiment, biostatisticians are actively involved in carrying out interim analyses. These analyses have several functions, including identifying the sample size’s suitability, analyzing the safety and effectiveness of the treatment, and monitoring the trial’s progress. Biostatisticians can discover potential patterns, quantify treatment effects, and decide whether any adjustments are required by reviewing all the collected data at interim time points.

Documentation of a Clinical Study

The statistical analysis element is one of the most significant duties a biostatistician has while creating a CSR. They are in charge of performing the proper statistical analysis to assess the trial’s results, efficacy, and safety measures. Biostatisticians are essential to accurately and succinctly interpreting and summarizing the statistical results in the CSR. They make sure that the data analysis is sound, the statistical methods are proper, and the results are presented in a way that is clear and easy to understand. Biostatisticians are crucial to the development of a detailed and well-documented CSR because their work has a big impact on how regulatory authorities will assess it.

Common Statistical Concerns in Clinical Trials

Clinical trials include a number of statistical issues, the most prevalent of which are the incorrect interpretation of p-values. The necessity of reporting confidence intervals, the reporting of clinical trial data, and the significance of efficient communication.

The misuse of the p-value and excessive reliance on it are two of the main problems in medical research. The p-value is known in the context of a hypothesis test, which involves the establishment of complementary hypotheses. A null hypothesis (which is assumed to be true), and an alternative hypothesis (the assertion that researchers want to prove). Confidence intervals must always be presented in clinical trial results reports to help determine effect sizes that can be ruled out (i.e., effect sizes that don’t match the data). The scientific field has a significant problem with the lack of reporting of confidence intervals. Confidence intervals should be included with p-values rather than serving as a substitute for them.1


Errors can occur at numerous points throughout the course of clinical trials. For this reason, it is ideal to incorporate a statistician early in the development of the clinical study so that they can foresee potential hurdles. When conducting or taking part in clinical trials, individuals should familiarize themselves with frequent statistical concerns and challenges. The potential and most prevalent statistical issues that can arise during a clinical trial are described in this blog. Clinical trials of the finest quality can be ensured by remaining informed of these problems.


  1. Evans SR. Common statistical concerns in clinical trials. J Exp Stroke Transl Med. 2010;3(1):1-7. doi:10.6030/1939-067x-3.1.1

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