Biostatistics plays a crucial role in all phases of clinical trials, contributing to the design, analysis, interpretation, and reporting of study results. Biostatisticians collaborate with other researchers, clinicians, and experts to ensure that clinical trials are conducted with scientific rigor and that the data generated are meaningful and valid. Here's a breakdown of the key roles of biostatistics in clinical trials

1. Welcome
Khateeja Begum
Pharm-D
169/082023
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
1
ROLE OF BIOSTATISTICS IN CLINICAL TRIALS

2. ROLE OF BIOSTATISTICS IN CLINICAL TRIALS
CONTENTS :
Overview of clinical trials
 Definition of biostatistics
Role of biostatistics in clinical trials
Applications of biostatistics in clinical research
References
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
2

3. 10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
3

4. 10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
4
Biostatistics is the development and application of statistical models and theories of inferential probability
and computing and mathematics resposible 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.

5. 10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
5
Roles and Importance of Biostatistics in Clinical Research:
1.Protocol Development
In the protocol development in clinical researches, the following are the roles and responsibilities of the biostatistician
•Objectives:
Based on the objective of the scientific manuscript, biostatisticians have to provide a clear specification of the hypothesis
to be tested. In other words, they have to provide the parameters to be tested. Also, they are responsible for selecting and
defining endpoints in clinical research.
•Study Design:
The study design of the biostatistician should provide the data needed to answer the objectives like:
1.Defining procedures to minimize selection bias
2.In the case of RCT or Randomized Control Trial, define randomization procedures like sequence generation and
allocation concealment and the length to follow up and frequency of contacts

6. 10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
6

7. 10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
7
• sample size:
• .Justifying the primary endpoint in terms of power or precision
• Methods used to calculate the sample size should be consistent with the primary method of data analysis and
also appropriate for the design
• Assumptions should be supported with proper historical data.
• Justification in terms of feasibility.
• Analysis plan summary:
• The purpose of analyzing plan summary is to assure objectives to be achieved and to justify design and data
collection byways like
• To provide the statistical methodology for the assessment of the primary objectives like testing procedures &
statistical hypothesis
• As per the role of DSMB or the Data Safety Monitoring Board to discuss statistical methods to be used in
planned interim analyses

8. 10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
8
• Protocol Review:
It is pertinent for the LSB or the lead study biostatistician to review the full protocol for checking the
following
1.Clarity
2.Completeness
3.Consistency
4.Data quality issues
5.Feasibility
• protocol writing:
To write randomization procedures, sample size, and analysis plan with the inputs from objectives,
endpoints study design, and allocation concealment.

9. 2. Data Management:
1.CRF management with content and design
2.Dataset specification with annotation of CRFs and record layout
3.Validation with error checking specification and test data
3. Study Implementation
It involves sampling selection and implementation of randomizes procedures
4. Study Monitoring
It involves monitoring of quality and for safety and efficacy
5. Data Analysis:
•A detailed analysis plan writing with all hypotheses to be tested along with the hierarchy of analysis
•It helps to prepare for reporting, manuscript writing, along with the validity and creditability of results
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
9

10. Biostatics Application in various fields of Clinical Research:
Clinical researches utilize biostatistics methods to provide formal accounting for sources of variability in patients’ response to
treatment. Also, it allows researchers to draw reasonable and precise inferences from the gathered information to make outstanding
decisions in times of uncertainty. It enables the collection, analyzing, presenting and interpreting data to find application in various
field like
•Epidemiology
•Clinical trials
•Population genetics
•Systems biology
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
10

11. Biostatistics help in Clinical Researches right from its start for:
•Designing
•Conducting
•Analyzing
•Reporting
•Minimizing biases
•Confounding factors
•Measuring random errors
•Understanding the research
•Make suggestions on hypothesis testing & analysis
•calculating the sample size
•determining the power of the study
•ensure conitinuity throughout the research
•asses the statistical significance of the result
•efficasy and safety of the drug
•line of treatment
•therapy.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
11

12. References:
http://www.icssc.org/Presentations/Aregentina%20Presentations/11%20The%20role%20of%20BIOS.pdf
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4900305/
https://www.researchgate.net/publication/233747688_Importance_of_Biostatistics_to_Improve_the_Quality_of_Medical_Journals/l
ink/0fcfd50b0e7729c7c5000000/download
https://newonlinecourses.science.psu.edu/stat509/node/2/
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
12

13. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
13