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The Importance and Role of Biostatistics in Clinical Trials

Statistics has been an integral part of research studies for centuries. It is an essential tool for formulating research design, data collection, organization, analysis, and interpretation. This, in turn, helps to draw conclusions and report the findings of quantitative research.

In simple words, statistical methods help researchers to support and validate their findings with quantifiable data and to communicate their findings in a comprehensible format to the public. While statistics are used in all types of quantitative research, the methods used can vary across industries. The statistical processes and methods used to collect, analyze, and interpret biological data are classified under biostatistics.

A vector illustration for a clinical trial

A Brief Introduction to Biostatistics

Although the term biostatistics refers to the use of statistical methods for any biological research, it particularly applies to the data relating to humans; their biology, health, and medicines.[1] Researchers use the tools of statistics to answer pressing research questions in medicine.[2] These include identifying the underlying causes of diseases, calculating the chances of survival for patients of certain diseases, and figuring out the effects, safety, and effectiveness of new drugs and treatment processes. This applies to all stages of testing – laboratory testing, animal testing, and clinical trials.

Biostatistics and Clinical Trials

Clinical trials are a fundamental part of the development and approval processes of new drugs, devices, and treatment methods in the field of medicine and public health. The use of statistical tools during clinical trials help experts draw quantifiable conclusions regarding the safety and efficacy of new medicine, device, or treatment process.

Since it is a comprehensive process and requires an in-knowledge of statistical concepts and methodologies, medical researchers should work together with biostatisticians to avoid mistakes at various stages of clinical trials. Research shows that misinterpretation of statistical data is a common problem in clinical research, and the underlying cause of it is the lack of knowledge about various statistical concepts.

What Can a Biostatistician Help You With During a Clinical Trial?

A biostatistician is required during every stage of a clinical trial to draw maintain the integrity of the whole process. The standard stages of a clinical trial include:

  • Protocol Development & Design

  • Data Management

  • Study Implementation

  • Study Monitoring

  • Data Analysis & Reporting

A biostatistician works closely with other experts, including data managers, medical writers, and statistical programmers, to ensure each step of the process is completed without any mistake. A biostatistician is also responsible for outlining hypothesis and testing procedures and the endpoints of a research study as well as for sample size calculation and interim analysis planning, in the Statistical Analysis Plan (SAP).

The Sum Up

It wouldn’t be wrong to say that biostatistics is a key element to ensure a smooth flow of clinical data throughout a clinical trial. Hence, biostatisticians are point persons for biotech and pharmaceutical companies to run successful clinical trials for their products.

At Wellness Clinical Research, we take clinical trial data seriously. We understand the complexities of trial design and protocol development. That is why we put extra emphasis on data management and adhering to the protocol. Our team of trained researchers is ready to help you run successful clinical trials for your new groundbreaking discoveries. Get in touch with us to discuss your project!

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