Biostatistics is the cornerstone of clinical trial design and analysis, ensuring that trials are conducted with scientific rigor, that the data is reliable and interpretable, and that the conclusions drawn from the trials are valid. Their role is central to the successful development and evaluation of new treatments and therapies, ultimately contributing to the advancement of medical science and patient car

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ROLE OF BIOSTATISTICS IN CLINICAL TRIALS
Monika Markad
B. Pharmacy
191/092023
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ROLE OF BIOSTATISTICS IN CLINICAL TRIALS
CONTENTS:
Overview of clinical trials
What is Biostatistics
Role of biostatistics in clinical trials
Applications of biostatistics in clinical research

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What is Biostatisticians?
 Biostatisticians in clinical trial management have a long to-do list.
 They advise on study design, calculate the right sample size, and ensure that the enrolled patients are correctly
randomized.
 They help define endpoints, provide definitions for data analysis and create tables and figures for the clinical study
report. They help define endpoints, provide definitions for data analysis and create tables and figures for the clinical
study report.

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Who is a Biostatistician?
 A biostatistician is a professional who uses statistics to analyze data from clinical trials. Biostatisticians work for
pharmaceutical companies, universities and research institutes. They can also be employed by government agencies and
non-profit organization.

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Roles of biostatistics in clinical trials:
Development of protocol:
Every clinical trial needs a plan, and that plan is known as the ‘clinical trial protocol.”
Protocol development:
Protocol development involves the following steps:
Objective:
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.

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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.
Analysis:
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.
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

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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.
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.
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.

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Applications of biostatistics in clinical research:

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