PRACTICAL

COMPONENTS OF INDUSTRIAL
AND
CLINICAL TRAILS PROBLEMS
PROJECT REPORT
SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS
FOR THE DEGREE OF
Bachelor of Pharmacy
SUBMITTED BY
ADITYA SRIVASTAV
ROLL NO :- 181251016004
UNDER THE GUIDENCE OF
Dr. RAM NARAYAN PRAJAPATI
DEPARTMENT OF PHARMACY
BUNDELKHAND UNIVERSITY
JHANSI
SESSION 2022-2023
 CERTIFICATE

This is certify that project is on “PRACTICAL COMPONENTS OF INDUSTRIAL AND

CLINICIAL TRAILS PROBLEMS” has been successfully delivered by ADITYA
SRIVASTAV Bachelor final year, under my guidance in fulfillment of the “Bachelor of
Pharmacy” session 2022-2023 in the Department of Pharmacy, Bundelkhand
University, Jhansi.

DR. PEEYUSH BHARDWAJ DR. RAM NARAYAN PRAJAPATI

(HOD) (PROJECT GUIDE)

RESPECTED EXAMINER

ACKNOWLEDGEMENT

Page | i
With a deep sense of gratitude. I wish to express my sincere thanks to my guide, Dr.
Ram Narayan Prajapati Sir, Pharmacy department for giving us the opportunity to
work under him on thesis. I truly appreciate and value his esteemed guidance and
encouragement from the beginning to end of this thesis. We are extremely grateful to
him. His knowledge and company at this time of crisis would be remembered lifelong. I
also wish to express my sincere thanks to our Dr. Peeyush Sir (Head Of Department)
of Pharmacy Department for providing a solid background for my studies and research
thereafter. They have been great sources of inspirations toes and we thank them from
the bottom of my heart. We will be failing in our duty if we do not mention the
laboratory staff and administrative staff of this department for their timely help. We also
want to thanks our parents, who taught us the value of hard work by their own
example. We would like to share this moment of happiness with our parents. Finally,
we would like to thank all whose direct and indirect support helped us completing our
thesis in time. We would like to thank our department for giving us the opportunity and
platform to make our effort a successful one.

TABLE OF CONTENT

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S. No Chapter Topic Page. No

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01. Chapter -1 Certificate (i)
02. Chapter -2 Aknowledgment (ii)
03. Chapter -3 List of Contents (iii)
04. Chapter -4 An Overview
05. Chapter -5 Introduction
06. Chapter -6 Computer Software
07. Chapter -7
08. Chapter -8
09. Chapter -9
10. Chapter -10

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PRACTICAL COMPONENT OF INDUSTRIAL AND CLINICAL TRAILS PROBLEMS

An Overview

Clinical trials industry has seen a perceptible increase in recent

years and India is one of the global destination for clinical trials.
The safety and the efficacy of all new treatment as a drug,
vaccine, medical devices, dietary supplements etc. is analysed
through clinical trials.

Clinical trials are most important part in drug discovery for

treatment of diseases such as COVID-19, swine flu, cancer etc.

Clinical trials are experiments or observations in clinical

research to generate data on safety and efficacy of new
molecules. Based on type of new molecules, researchers or
investigators initially select small group of volunteers or
patients and subsequently conduct larger scale comparative
studies. Clinical study design aims to ensure the scientific
validity and reproducibility of the results. In clinical trials, the
number of subject (sample size), has a large impact on the
ability to measure the effects of the interference. This ability is
described as its ‘power’ and a larger sample size increases the
statistical power. The statistical power estimates the ability of a
trial to detect a difference of a particular size between the
treatment and control groups.

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INRODUCTION
Clinical trial management systems are often used by research sponsors or contract
research organizations (CROs) for planning and management of clinical trials. Interactive
voice response system is also used by sites to register the enrollment of patients using a
phone and to allocate patients to a particular treatment arm. Statistical software is used
to analyze the collected data and prepare the outcomes for regulatory submission. The
most commonly used packages for statistical analysis are Excel, SPSS, MINITAB, SAS
JMP, STATA, S-PLUS, R, SOLAS, etc. GraphPad Prism is most useful for researcher to
perform laboratory studies and clinical trial test using t-test, one-way ANOVA, survival
analysis and probability models like logistic regression model.
SAS (Statistical Analysis Software) is available only for windows operating systems and
commonly used for statistical analysis and data visualization. Statistical software’s are
specialized programs designed to allow users to perform complex statistical analysis.
These software’s are tools for the organization, interpretation and presentation of
selected data sets.
There are many challenges or problems to perform industrial and clinical trials in a
developing country like India. The main problems are lack of experts with formal
training in bioethics, limited experience with regulatory trials, infrequent meeting of
Institute Ethics Committees (IECs) and lack of clearly defined roles and responsibilities of
its members.
Clinical investigators may face many challenges such as funding, responding to multiple
review cycles, recruiting patients, establishing clinical trial and material transfer
agreements with sponsors and medical centers, time-bound research studies and
completing associated paper work.
Cost of clinical trials are very high and it may be billions of dollars per approved drug.
Clinical trials may be sponsored by pharmaceutical industry or any other government
organization. A clinical trial might also include an extended post-study follow-up period
from month to years for patient or people who have participated in the trial. The main
barrier for completing studies is the shortage of patient or people who take part in the
trials. Some drug trials require patients to have unusual combinations of disease
characteristics. It is a challenge to find the appropriate patients and obtain their
consent. The studies perhaps performed in selected months to avoid seasonal

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PRACTICAL COMPONENT OF INDUSTRIAL AND CLINICAL TRAILS PROBLEMS

influences such as airborne allergies, influenza, skin diseases, seasonal affective disorder
etc.

COMPUTER SOFTWARE

Introduction to Microsoft Excel ( Spread Sheets)

Microsoft Excel provides the system in which available
data can be presented in organized and systematic
manner. A spread sheet is a computer program sheet
or document that we can use for arithmetic
computations in columns and rows.
There are numbers of spreadsheet programs but from
all of them, Excel is most widely used. People have
been using it for last 30 years and throughout these years, it has been upgraded with
more and more features.
The best part about Excel is, it can apply to many business tasks, including statistics,
finance, data management, forecasting, analysis, inventory, billing and business
intelligence.
Following are the few things which it can do for you :-
Number Crunching
Charts and Graphs
Store and Import Data
Manipulating Text
Templates/Dashboards
Automation of Tasks
And much more…
Three most important components of Excel is which you need to understand :-

1. Cell :- A cell is a smallest but most powerful part of a spreadsheet. You can enter
your data into a cell either by typing or by copy-paste. Data can be a text, a number,

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PRACTICAL COMPONENT OF INDUSTRIAL AND CLINICAL TRAILS PROBLEMS

or a date. You can also customize it by changing its size, font color, background
color, borders etc.

Every cell is identified by its cell address, cell address contains its column number
and row number (If a cell is on 11 th row and on column AB, then its address will be
AB11).

2. Worksheet :- A worksheet is made up of individual cells which can contain a value,

a formula, or text. It also has an invisible draw layer, which holds charts, images, and
diagrams. Each worksheet in a workbook is accessible by clicking the tab at the
bottom of the workbook window. In addition, a workbook can store chart sheet; a
chart sheet displays a single chart and is accessible by clicking a tab.
3. Workbook :- A workbook is a separate file just like every other application. Each
workbook contains one or more worksheets. You can also say that a workbook is a
collection of multiple worksheets or can be a single worksheet. You can add or
delete worksheets, hide them within the workbook without deleting them, and
change the order of your worksheets within the workbook.

Microsoft Excel Window Components

Before you start using it, it’s really important to understand that what’s where in its
window. So ahead we have all the major component which you need to know before
entering the world of Microsoft Excel.

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PRACTICAL COMPONENT OF INDUSTRIAL AND CLINICAL TRAILS PROBLEMS

 Active Cell :- A cell which is currently selected. It will be highlighted by a

rectangular box and its address will be shown in the address bar. You can activate a
cell by clicking on it or by using your arrow buttons. To edit a cell, you double-click
on it or use F2 to as well.
 Columns :- A column is a vertical set of cells. A single worksheet contains 16384
total columns. Every column has its own alphabet for identity, from A to XFD. You
can select a column clicking on its header.
 Rows :- A row is a horizontal set of cells. A single worksheet contains 1048576 total
rows. Every row has its own number for identity, starting from 1 to 1048576. You
can select a row clicking on the row number marked on the left side of the window.
 Fill Handle :- It’s a small dot present on the lower right corner of the active cell. It
helps you to fill numeric values, text series, insert ranges, insert serial numbers, etc.
 Address Bar :- It shows the address of the active cell. If you have selected more
than one cell, then it will show the address of the first cell in the range.
 Formula Bar :- The formula bar is an input bar, below the ribbon. It shows the
content of the active cell and you can also use it to enter a formula in a cell.
 Title Bar :- The title bar will show the name of your workbook, followed by the
application name (“Microsoft Excel”).
 File Menu :- The file menu is a simple menu like all other applications. It contains
options like (Save, Save As, Open, New, Print, Excel Options, Share etc).
 Quick Access Toolbar :- A toolbar to quickly access the options which you
frequently use. You can add your favorite options by adding new options to quick
access toolbar.
 Ribbon Tab :- Starting from the Microsoft Excel 2007, all the options menus are
replaced with the ribbons. Ribbon tabs are the bunch of specific option group which
further contains the option.
 Worksheet Tab :- This tab shows all the worksheets which are present in the
workbook. By default you will see, three worksheets in your new workbook with the
name of Sheet1, Sheet2, Sheet3 respectively.
 Status Bar :- It is a thin bar at the bottom of the Excel window. It will give you
instant help once you start working in Excel.


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PRACTICAL COMPONENT OF INDUSTRIAL AND CLINICAL TRAILS PROBLEMS

Data Collection in Microsoft Excel

Data collection in any
process in which
information is gathered
and expressed in a
summary from, for
purposes such as
statistical analysis. A
common collection
purpose is to get more
information about
particular groups based
on specific variables such
as age, profession, or
income. The information about such groups can then be used for website
personalization to choose content and advertising likely to appeal to an individual
belonging to one or more groups for which data has been collected. For example, a site
that sells music CDs might advertise certain CDs based on the age of the user and the
data collection for their age groups.
Collection or grouping is common task in database management. It allows obtaining
summary statistics (e.g. mean, sum, max, etc.) of one or more quantitative variables.
The data can be collected in Excel using the XLSTAT statistical software. Excel sheet with
both the data and the results can be downloaded by clicking on the button given button.
XLSTAT is user friendly software which is used to analyzing the data of statistics. It was
by Thierry Fahmy develops developed in 1993.
This software is used to summarize data using simple statistics like mean, median
standard deviation etc. It easily extract information from a large data set form. It helps
to accept or reject a very precise hypothesis assuming error risks. It is used in modelling
by the way of phenomenon according to the set of parameters.
On XLSTAT software the following applications may perform: Using Simple Linear
Regression and multi Linear Regression XLSTAT a statistical model can be developed to
solve the problems.

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STATISTICAL PACKAGE FOR THE SOCIAL

SCIENCES (SPSS)
SPSS means “Statistical Package for the Social Sciences” and was first launched in 1968.
Since SPSS was acquired by IBM in 2009, it's officially known as IBM SPSS Statistics
but most users still just refer to it as “SPSS”.

SPSS is a widely used program for statistical analysis in social science. It is also used by
market researchers, health researchers, survey companies, government, education
researchers, marketing organizations, data miners and other. The original SPSS manual
Nie, Bent and Hull, 1970 has been described as one of “sociology’s most influential
books” for allowing ordinary researchers to do their own statistical analysis.

SPSS is a trial ware that you can use to record and then analyze data. While the original
developers of the statistical tool are SPSS Inc., IBM acquired the software, which is now
called IBM SPSS Statistics. The SPSS software is highly customizable to let you enter
the exact data that you need, like variables and numbers.

SPSS has a user interface that looks like Microsoft Excel as the UI is set up as a
spreadsheet. MITLAB, MINITAB, POWER BI, Stata, MYSQL, and Tableau are data
management alternatives to SPSS. All programs are suitable for professional use.

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PRACTICAL COMPONENT OF INDUSTRIAL AND CLINICAL TRAILS PROBLEMS

SPSS – Quick Overview Main Features

SPSS is software for editing and analyzing all sorts of data. These data may come from
basically any source: scientific research, a customer database, Google Analytics or even
the server log files of a website. SPSS can open all file formats that are commonly used
for structured data such as

Spreadsheets from MS Excel

Plain text files (.txt or .csv)
Relational (SQL) databases
Stata and SAS

Let's now have a quick look at what SPSS looks and feels like.

SPSS data view :-

After opening data, SPSS displays them in a spreadsheet

This sheet called data view - always displays our data values. For instance, our first
record seems to contain a male respondent from 1979 and so on. A more detailed
explanation on the exact meaning of our variables and data values is found in a second
sheet shown next page.

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PRACTICAL COMPONENT OF INDUSTRIAL AND CLINICAL TRAILS PROBLEMS

SPSS Variable View :-

An SPSS data file always has a second sheet called variable view. It shows the metadata
associated with the data. Metadata is information about the meaning of variables and data
values. This is generally known as the “codebook” but in SPSS it's called the dictionary.

For non SPSS users, the look and feel of SPSS’ Data Editor Window probably come
closest to an Excel workbook containing two different but strongly related sheets.

Data Analysis :-
Right, so SPSS can open all sorts of data and display them and their Meta data in two
sheets in its Data Editor window. So how to analyze your data in SPSS?

Well one option is using SPSS elaborate menu options.

For instance, if our data contain a variable holding respondents’ incomes over 2010, we
can compute the average income by navigating to Descriptive Statistics as shown below

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PRACTICAL COMPONENT OF INDUSTRIAL AND CLINICAL TRAILS PROBLEMS

Doing so opens a dialog box in which we select one or many variables and one or several
statistics we'd like to inspect.

SPSS Output Window :-

After clicking OK, a new window opens up: SPSS’ output viewer window. It holds a
nice table with all statistics on all variables we chose. The screenshot below shows what
it looks like.

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PRACTICAL COMPONENT OF INDUSTRIAL AND CLINICAL TRAILS PROBLEMS

As we see, the Output Viewer window has a different layout and structure than the Data
Editor window we saw earlier. Creating output in SPSS does not change our data in any
way; unlike Excel, SPSS uses different windows for data and research outcomes based on
those data.
For non SPSS users, the look and feel of SPSS’ Output Viewer window probably comes
closest to a PowerPoint slide holding items such as blocks of text, tables and charts.

SPSS Reporting :-
SPSS Output items, typically tables and charts, are easily copy pasted into other
programs. For instance, many SPSS users use a word processor such as MS Word,
OpenOffice or GoogleDocs for reporting. Tables are usually copied in rich text format,
which means they'll retain their styling such as fonts and borders. The screenshot below
illustrates the result

SPSS Syntax Editor Window :-

The output table we showed was created by running Descriptive Statistics from SPSS
menu. Now, SPSS has a second option for running this (or any other) command: we can
open a third window, known as the syntax editor window. Here we can type and run
SPSS code known as SPSS syntax.

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For instance, running descriptive income 2010. Has the exact same result as running this
command from SPSS’ menu like we did earlier.

Besides typing commands into the Syntax Editor window, most of them can also be
pasted into it by clicking through SPSS’ menu options. Like so, SPSS users unfamiliar
with syntax can still use it. But why use syntax if SPSS has such a nice menu?
The basic point is that syntax can be saved, corrected, rerun and shared between projects
or users. Your syntax makes your SPSS work replicable. If anybody raises any doubts
regarding your outcomes, you can show exactly what you did and -if needed-correct and
rerun it in seconds.
For non SPSS users, the look and feel of SPSS’ Syntax Editor Window probably come
closest to Notepad: a single window basically just containing plain text.

SPSS – Overview Main Features :-

Now that we have a basic idea of how SPSS works, let's take a look at what it can do.
Following a typical project workflow, SPSS is great for

Opening data files, either in SPSS’ own file format or many others;
Editing data such as computing sums and means over columns or rows of data.
SPSS has outstanding options for more complex operations as well.
Creating tables and charts containing frequency counts or summary statistics over
groups of cases and variables.
Running inferential statistics such as ANOVA, regression and factor analysis.
Saving data and output in a wide variety of file formats.

We'll now take a closer look at each one of these features.

Opening Data Files :-

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SPSS has its own data file format. Other file formats it easily deals with include MS
Excel, plain text files, SQL, Stata and SAS.

Editing Data :-
In real world research, raw data usually need some editing before they can be properly
analyzed. Typical examples are creating means or sums as new variables, restructuring
data or detecting and removing unlikely observations.

SPSS performs such tasks and more complex ones with amazing efficiency.
For getting things done fast, SPSS contains many numeric functions, string functions,
date functions and other handy routines.

Tables and Charts :-

All basic tables and charts can be created easily and fast in SPSS. Typical examples are
demonstrated under Data Analysis.

A real weakness of SPSS is that its charts tend to be ugly and often have a clumsy
layout. A great way to overcome this problem is developing and applying SPSS chart
templates. Doing so, however, requires a fair amount of effort and expertise.

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Inferential Statistics :-
SPSS contains all basic statistical tests and multivariate analyses such as :-

t-tests
chi-square tests
ANOVA
correlations and other association measures
regression
nonparametric tests
factor analysis
cluster analysis

Some analyses are available only after purchasing additional SPSS options on top of the
main program.

An overview of all commands and the options to which they belong is presented in
Overview All SPSS Commands.

Saving Data and Output :-

SPSS data can be saved as a variety of file formats, including :-

MS Excel
plain text (.txt or .csv)
Stata
SAS

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The options for output are even more elaborate: charts are often copy pasted as images
in .png format.

For tables, rich text format is often used because it retains the tables, layout, fonts and
borders.
Besides copy-pasting individual output items, all output items can be exported in one go
to .pdf, HTML, MS Word and many other file formats. A terrific strategy for writing a
report is creating an SPSS output file with nicely styled tables and chart. Then export the
entire document to Word and insert explanatory text and titles between the output items.

MINITAB

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