Unit-IV 8 Hours
4.1 Blocking and confounding system for Two-level factorials
(1h)
4.2 Regression modeling: Hypothesis testing in Simple and
Multiple regression models
4.3 Introduction to Practical components of Industrial and
Clinical Trials Problems: (1 h)
Statistical Analysis Using Excel, SPSS, MINITAB®, DESIGN
OF EXPERIMENTS, R - Online Statistical Software’s to
Industrial and Clinical trial approach
Using R Programming for Clinical Trial Data Analysis
What is R Programming?
R is an open-source programming language that supports
a wide range of statistical and graphical methodologies.
It excels at data manipulation, calculation, and graphical
display, making it a top choice for data analysis and
statistical modelling.
How R is Used in Clinical Trials?
R is commonly used in various stages of clinical trials
because of its strong statistical capabilities, versatility, and
capacity to handle complex data processing. Here are a
few summaries of how R is used in clinical trials:
Study Design and Planning
Designing and planning a study in R involves a series of
steps, starting with defining what you want to achieve and
the hypotheses you want to test. Once you have a clear
idea of your objectives, you can move on to planning the
statistical analyses you'll need and any simulations
required to support your study. R offers a variety of tools
and packages to help you with each of these steps,
making it easier to design and execute your research
effectively.
Data Management
Managing data in R means organising,
cleaning, and getting your data ready for
analysis. Good data management makes
sure your data is accurate and consistent,
so you can trust your results and perform
reliable statistical analysis.
Handling Missing Values:
Missing values are a common problem in data analysis. They can be caused by several
factors such as data entry errors, measurement errors, or simply missing data. In R,
missing values are represented by NA. There are several functions available in R that can
help with handling missing values.
One of the most common functions is the na.omit() function, which removes any rows with
missing values. Another function is the complete.cases() function, which returns a logical
vector indicating which rows have complete data.
Data Transformation:
Data transformation involves changing the format or structure of the data to make it more
suitable for analysis. In R, there are several functions available for data transformation. One
common function is the subset() function, which subsets the data based on certain criteria.
Another useful function is the merge() function, which merges two data frames based on a
common variable.
Descriptive Statistics
Descriptive statistics are essential for summarizing and
making sense of your data. In R, you can calculate and
visualize these statistics to understand the overall pattern,
the average values, and how much the data varies. This
helps you get a clear view of your data's main
characteristics.
Efficacy Analysis
The study includes analysing both primary and secondary
outcomes. This involves using survival analysis methods,
such as Kaplan-Meier curves and Cox proportional
hazards models, to examine time-to-event data. We also
use mixed-effects models to analyse repeated measures
and test for non-inferiority and equivalence to compare
treatment effects. All of this can be programmed using R.
Safety Analysis
In clinical trials, safety analysis means evaluating any
adverse events and other safety-related data to check if a
treatment is safe for patients. In R, you can conduct this
analysis using different statistical methods and
visualizations to help identify and understand safety
concerns.
Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis
Pharmacokinetic (PK) and pharmacodynamic (PD) analysis
are essential in drug development. PK analysis helps us
understand how a drug is absorbed, distributed,
metabolized, and eliminated by the body, while PD
analysis shows how the drug affects the body. In R, you
can perform these analyses using different statistical
methods and specialized packages to get detailed insights
into a drug's behaviour and effects.
Statistical Programming
Statistical programming in R means using the R language
to analyse data, manage and visualize it, and create
reports. R is a great tool for statisticians and data scientists
because it has a wide range of libraries and is very flexible.
Several R packages are commonly used, such as survival
for analysing survival data, lme4 for mixed-effects
models, ggplot2 for creating visualisations, tidyverse for
data manipulation, emmeans for estimating marginal
means, gt for generating tables, and ctrdata for handling
trial data. These packages help with statistical modelling,
data handling, visualisations, and reporting. When using R
in clinical trials, there are often extra steps for validation
and documentation to meet regulatory standards. Despite
these requirements, R's capability to produce reliable and
reproducible results makes it a valuable tool for analysing
and reporting clinical trial data.
Graphics in R
R offers a wide range of options for visualizing data. You
can start with basic plots in base R and move on to more
advanced, interactive graphics using tools like ggplot2,
lattice, and plot. By learning how to use these tools, you
can create clear and engaging visuals that make it easier
to analyse and present your data. Whether you're a data
analyst, statistician, or researcher, mastering R’s graphics
will help you effectively share insights and make informed
decisions based on your data.
For example, the plot() function in R is not a single
specified function, but rather a placeholder for a group of
related functions. The specific function called will be
determined by the parameters given.
R Packages for Clinical Trial Design, Monitoring, and
Analysis:
R has many packages for medical writing Clinical Trial data analysis. Following are few examples:
A table (Create Tables for Reporting Clinical Trials),
compare OEM (Comparison of medical forms in CDISC ODM format),
CRTSize (Sample size estimation in a cluster (group) randomized trials),
Blockrand (creates randomizations for block random clinical trials),
DoseFinding (Supports design & analysis of dose-finding experiments),
Pact (Predictive Analysis of Clinical Trials),
SASxport (Read and Write ‘SAS’ ‘XPORT’ Files),
ADCT (Adaptive Design in Clinical Trials),
ClinPK, cpk (Clinical Pharmacokinetics Toolkit),
randomizeR (Randomization for Clinical Trials),
Base R (lot of functionality useful for design and analysis of clinical trials), Greport (Graphical Reporting for
Clinical Trials),
Coronavirus (Provides a daily summary of the Coronavirus (COVID-19) cases by state/province) etc.
