Biostatistics plays a critical role in clinical trials, providing the analytical framework necessary to ensure that the study is well-designed, accurately executed, and effectively analyzed. Biostatisticians work closely with clinical trial teams to help ensure that the study objectives are clearly defined, that appropriate statistical methods are selected, and that the data is analyzed in a way that is meaningful and accurate. Some of the key roles that biostatistics plays in clinical trials include: Study design: Biostatisticians help to design clinical trials by determining appropriate sample size, selecting appropriate endpoints, and defining the statistical analysis plan. This ensures that the study is adequately powered to detect meaningful differences and that the analysis is appropriate for the study design. Data analysis: Biostatisticians play a critical role in the analysis of clinical trial data. They develop statistical models to evaluate the primary and secondary endpoints of the study, and perform hypothesis testing to determine if the results of the study are statistically significant. Safety monitoring: Biostatisticians monitor safety data throughout the clinical trial to identify any adverse events or potential safety concerns. This allows the study team to take appropriate action to protect the safety and well-being of study participants. Reporting: Biostatisticians are responsible for reporting the results of the clinical trial in a clear and accurate manner. They work closely with the study team to develop statistical summaries and to interpret the study results in the context of the overall clinical trial objectives.

1. Welcome
ROLE OF BIOSTATISTICS IN CLINICAL TRIALS
Gali. Nikky bhedi
M Pharmacy
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2. Introduction
Biostatistics is the development and application of statistical models and theories of
inferential, probability and computing and mathematics responsible for interpreting
the scientific data generated in the health sciences.
• According to Lisa Sullivan from the Boston University School of Public Health,
“biostatistics is the application of statistical principles to questions and problems
in medicine, public health or biology”. This definition encapsulates the idea of
biostatistics being a field that overlaps with other fields.
• A more humanized definition was given by two American biostatisticians, Vance
Berger and J. Rosser Matthews. They define their discipline as a guide to, “how
we ought to make decisions when analyzing biomedical data”.
• For them, numbers are not the most important part of biostatistics, but rather the
decisions that are made using those numbers.
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3. When discussing biostatistics, one will encounter some recurring terminologies.
Here are some keywords in the biostatistics vernacular:
• Population. : the entire group studied.
• Sample. : a subgroup from the population
• Sample size. : number of participants or objects in a sample
• Relative risk. : ratio of the risk of an event to an exposed group compared to a non-exposed group
• Hypothesis. : a statement that tries to explain the relationship of two or more variables
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Introduction

4. • Clinical trials are research studies performed on people that are aimed at evaluating a medical, surgical, or behavioural
intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet, or medical device is
safe and effective in people.
• Often a clinical trial is used to learn if a new treatment is more effective and/or has fewer harmful side effects than the standard
treatment. A well-designed clinical trial is a gold standard for proving that a treatment or medical approach works, but clinical
trials can’t always be used.
• Experimentation with human volunteers
Investigates a new treatment/preventive agent
Safety
Efficacy
Effectiveness
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Clinical trials

5. Phase I
Purpose: the medical approach is safe, identifies side effects, and figures out appropriate doses.
Number of people: Typically fewer than 100
Phase II
Purpose: Start testing a medical approach that works. Continue monitoring for side effects; phase III trial.
Number of people: Typically 100-300
Phase III
Purpose: Prove whether a medical approach works; continue monitoring side effects.
Number of people: As many as needed or able to enroll can be 1,000 or more
Phase IV
Purpose: When a medical approach is being marketed, continue gathering information on its effects.
Number of people: Thousands
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Phases of clinical trials

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Importance and role of biostatistics in
Clinical Research

7. There are several methods of utilizing the knowledge of biostatistics in research, but one of the most interesting use
cases is medicine. A particular medical application of biostatistics is in clinical trials.
As mentioned above, biostatistics does not just come into the equation in the last part of clinical trials; it is critical from
the inception of a clinical trial.
• Study Design Development: biostatistics can be used to dictate the methods and direction of the research to be
undertaken
• Consolidating Evidence: a hefty amount of data can be sorted efficiently using biostatistics tools
• Data Analysis: not only does data need to be organized, but it also needs to be analyze to draw insights that could
prove or disprove a particular hypothesis
• Interpretation: because biostatisticians who are engaged in clinical trials have field-specific knowledge, they can
help provide interpretations of the results of the experiments
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Biostatistics for clinical trials

8. • Explanation of the trial to the participant followed by gathering more information from the participant.
• Getting a consent form signed by the participant.
• Screening and checking the participant whether he/she qualifies for the test.
• After selection, the participant is scheduled for a baseline visit (first visit). Here physical and cognitive tests
are conducted.
• The next step is placing the participant in the control group.
• Any issues or side effects faced by the participant should be reported to the researchers.
• Regularly scheduled visits by the participants at the research centre so the researcher could evaluate the
physical, cognitive along with side effects of the treatment.
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Biostatistics for clinical trials

9. Thank You!
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