ROLE OF BIOSTATISTICS IN CLINICAL RESEARCH

Introduction

Biostatistics is the branch of statistics responsible for the proper interpretation of

scientific data generated in biology, public health, and other health sciences (i.e.,

the biomedical sciences). In these sciences, subjects (patients, mice, cells, etc.)

exhibit considerable variation in their response to stimuli.

Clinical trials are an Investigation of human being intended to discover (or) verify

the clinical, pharmacological, & pharmacodynamic of the investigational

medicinal product.

Biostatistics in the broadest sense describes the process of developing and using

statistical methods to gain knowledge from biological data. While biological data

may refer to very different types of information, we will put focus on clinical trials.

1. It 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.

2. Statistical method encompass design of a wide range of biological experiment.

3. Pharmaceutical studies and clinical trials, It have developed in the directions of

 clinical trial methodology.

What exactly are biostatisticians doing?

The biostatistical analysis is key to conducting new clinical research in one of the
foundations of evidence-based clinical practice. It evaluates and applies prior
research findings precisely for the new research with less than 10% of the new
compounds reaching the market. The need for new biostatistics is increasing
daily. It is because it shortens timelines and reduces costs and risks by improving
the submission quality. State-of-the-art statistical methods now play a key role in
all the steps of the drug development process.

Importance and Roles of Biostatistics in Clinical Research

1. Protocol development

In the protocol development in clinical research the subsequent, the roles and
responsibilities of the biostatistician.

• Objectives

Supported the target of the scientific manuscript, biostatisticians have to provide

a clear specification of the hypothesis to be tested. In other words, they need to

supply the parameters to be tested. Also, they're responsible for selecting and

defining endpoints in clinical research.

• Study design

The study design of the biostatistician has provided the data needed to answer the

objectives like

1. Defining procedures to reduce the selection bias

2. In the case of RCT (Randomized control trial), define randomization

procedures like sequence generation and allocation concealment and therefore the

length of follow-up and frequency of contacts.

• Analysis plan summary

The purpose of analyzing the plan summary is to assure objectives are

achieved and to justify design & data collection in many ways.

To provide the statistical methodology for the assessment of the primary

objectives, like testing procedures and statistical hypothesis.

As per the role of DSMD (data safety monitoring board to discuss),

statistical methods are to be used in plan interim analysis.

• Protocol Review

It's pertinent for the LSB or the (lead study biostatistician) to review the

full protocol for checking the following subsequently.

1. Clarity

2. Completeness

3. Consistency

4. Data quality issues

• Protocol writing

To write randomization procedures, sample size & analysis plan with the inputs

from objectives and endpoints Study design and allocation concealment.

2. Data management

• CRF management with content and design

• Dataset specification with annotation of CRFs & record layout.

• Validation with error checking specification test. In test data.

3. Study implementation.

It involves sampling selection and implementation of randomized procedures.

4. Data Analysis

A detailed analysis is set up in writing with all hypotheses to be tested along with

the hierarchy of research.

It helps to prepare for reporting manuscript writing, along with the validity and

creditability of results.

5. Manuscript writing

Method section with statistical methodology & description of data with endpoints

in design.

• Result section includes the data presented in the form of graphs, tables, and

others.

• Discussion section with the appropriate interpretation of the results.

Biostatistics has become crucial for modern-day clinical researchers to

understand them better and for various other uses.

Written By: G. Lokeshwara Reddy

Qualification: B. Pharmacy

ID: CSRPL_INT_OFL_WKD_147/0822 

Email ID: gayamlokesh736@gmail.com