biostatistics clinical trials

A note on the Role of biostatistics in clinical trials

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Before we talk about the role of Biostatistics, let us first understand its definition. What do we understand by the term Statistics? As we all know, statistics are applied mathematics that deals with collecting, classifying, analyzing and interpreting mathematical data. Here, Biostatistics is the branch of statistics that collects and analyzes biological and health data. It is a study of new drugs and their interactions, what causes Cancer or other diseases, how long a person with Cancer and other diseases survives, and what can be a possible treatment for that disease. It is applied in many areas of Biology, including Epidemiology, medical science, health science, environmental science and Pharmaceutical science.

Lisa Sullivan from the Boston University school of public health defines Biostatistics as ‘’the application of statistical principles to questions and problems in medicine, public health or biology”.

The evolution of Biostatistics took place in the early 17th century and has been growing stronger since then. ‘Francis Galton is known as the father of statistics. He was the first person to Introduce Biostatistics and use statistical tools to understand the variations in the human population. He created the concept of ‘Correlation’.

One of the greatest statisticians, Karl Pearson, is well-known for his notable works in biostatistics. He introduced the probability value or P-value, which is an excellent introduction to his works. He is known as the founder of modern statistics. He was the first ever person to have found the first University Statistics Department. He followed Galton’s theory and contributed to the meteorology, biometrics, and eugenics fields.

Biostatistics has been helping researchers in their analysis since the very beginning and now, it’s been used in medical research, Clinical research, health management and many more fields. It helps the researchers answer the questions related to drugs, biology and public health that have been imposed on them. Biostatistics is applied in various research fields and has played a major role in clinical research. 

Biostatistics in Drug development

Biostatistics plays a crucial role in evidence-based drug development. Biostatistics is the only key element in the whole drug development process. With the increased demand for drugs and less production, the demand for advanced biostatistics has increased. It conducts prior research yielding accurate results. Only around 10% of the new compounds reach the market; hence, the demand for advanced Biostatistics has increased. It fastens the process, makes it cost efficient and reduces the risk by improving the drug quality.   

biostatistics clinical trials

Role of Biostatistics in Clinical research

Biostatistics is applied right from the inception of any clinical trial to the conclusion. It is utilized in clinical research in collecting, analyzing, presenting and interpreting data. It helps make decisions concerning the drug’s efficacy, interaction, and line of treatment. 

  1. Development of protocol- 

Every clinical trial needs a plan, and that plan is known as the ‘clinical trial protocol.”

Protocol development involves the following steps:


The main objective of the protocol is to generate a clear statement of the Hypothesis to be tested. It decides the selection and the endpoint of the trial in clinical research.

Developing the study design:

  • It depicts the type or design of the trial to be conducted (i.e., double-blind, placebo-controlled, parallel structure) and a schematic representation of the trial design, techniques, and stages.
  • It defines the measures to be taken to minimize or avoid bias.
  • Describing randomization procedures such as sequence generation, concealment of allocation and the frequency of follow-up.

Sample size estimation

Sample size estimation is one of the significant aspects of protocol development. Biostatistics plays an essential role in estimating the sample size in clinical trials. It depicts the effects of sample over-estimation and under-estimation. It puts forward the importance of minimal sample in the clinical trial


The primary purpose of the analysis is to ensure the objectives which are to be achieved—organizing data to draw conclusions that could prove or disprove the Hypothesis.

Protocol review

The data provided by the biostatistician at the end of the analysis is reviewed to check for its consistency, clarity, completeness, data quality and feasibility by the Institutional review board.

Protocol writing

Protocol writing is an inevitable document that helps the researcher to review and evaluate, which serves as a guide throughout the investigation.

  1. Data management

Clinical data management is a process of collecting, clearing and managing the data. The data which is curated at the end of the protocol is documented. Biostatistics helps provide high-quality data with the least errors through all the clinical trial stages. Data quality plays an important role in the study’s outcome. Software applications are used to meet the objective of providing reliable and correctly processed data. These software applications quickly identify and resolve discrepancies. Specific innovations have helped in managing large trials of clinical research.

  1. Study implementation and monitoring

The sample is selected and the randomized procedures are implemented. The process is continuously monitored for quality and drug’s efficacy and safety.

  1. Data analysis 

Biostatistics helps analyze the data produced through the implementation and monitoring with all the hypotheses that need to be tested. It helps in manuscript writing and preparing a report.

  1. Manuscript writing

It helps in describing the data with endpoints and design. The results are represented in the form of a graph or table or chart. It also includes a discussion section with relevant results.

Biostatistics has become crucial in clinical research as it eases the research process and generates more compounds in less time.

biostatistics clinical trials

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