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.

What exactly are biostatisticians doing?

It is a widely spread view that biostatisticians should be involved only after data will be collected but involving a biostatistician in all aspects that relate to the statistical evaluation of the trial already in the planning phase can efficiently save time and money throughout the whole duration of the trial

This section consists of 3 phases

1. Planning phase

2. Active phase

3. Close-up Phase

First, the Planning Phase starts with the first idea of the clinical trial, and just before starting with the requirement of the first patient

Secondly, the Active Phase starts with the requirement of the first patient and ends after all trial participants have completed the trial

Finally, the Close-up Phase includes all activities after all participants have completed the trial.

Biostatics and evidence-based clinical practice in drug development.

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 hypotheses. 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.

References

1. The importance and role of biostatistics in clinical research available at: http://www.icssc.org/Presentations/Aregentina%20Presentations/11%20The%20role%20of%20BIOS.pdf

2. Barkan H. Statistics in clinical research: Important considerations. Ann Card Anaesth. 2015 Jan Mar;18(1):74-82. doi: 10.4103/0971- 9784.148325. PMID: 25566715; PMCID: PMC4900305.Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4900305/

3. Biostatistics to improve the quality of medical journals. Available at: https://www.researchgate.net/publication/233747688_Importance_of_Biostatistics_to_Improve_the_Quality_of_Medical_Journals/link/0fcfd50b0e7729c7c5000000/download

WRITTEN BY

NAME: G Lokeshwara Reddy

QUALIFICATION: B Pharmacy

ID: 147/0822

EMAIL ID: gayamlokesh736@gmail.com