Statistical Software’s

to Industrial and
Clinical trial approach
Introduction
• Statistics Literacy and critical thinking is necessary in today’s world
that is fascinated with numbers and data.
• Even if one is not responsible for conducting statistical analysis, one
needs the basic understanding to properly use the information for
decision making.
• With proper guidance, monitoring, and diligent care, students were
exposed early on scripting, discrete probability distributions, sampling
distributions and statistical inference, design of experiments, analysis
of variance.
General principles that should be
considered in the conduct of clinical
trials
1. Clearly state the objective(s).
2. Document the procedure used for randomization.
3. Include a suitable number of patients (subjects) according to statistical
principles
4. Include concurrently studied comparison (control) groups.
5. Use appropriate blinding techniques to avoid patient and physician bias.
6. Use objective measurements when possible.
7. Define the response variable.
8. Describe and document the statistical methods used for data analysis.
The basic principles of good design:
1. absence of bias;
2. absence of systematic error (use of controls);
3. adequate precision;
4. choice of patients;
5. simplicity and symmetry.
EXCEL
• Excel offers a wide range of statistical functions which can be used to
calculate a single value or an array of values in the Excel worksheets.
• The Excel Data Analysis Toolpak is an add-in that provides even more
statistical analysis tools and can be a useful tool for statistical analysis
in both industrial and clinical trial settings, but it has limitations and
should be used with caution.
• Excel has statistical worksheet functions, Each one returning a value
into a selected cell. Excel also has an array formula. An array formula
calculates a set of values rather than just one. Each one returns an
array of values into a selected array of cells.
• In industrial settings, Excel can be used to analyze data from quality control
tests, such as process capability analysis and control charts.
• It can also be used to perform regression analysis and other basic statistical
tests, such as t-tests and ANOVA.
• However, Excel may not be suitable for analyzing large data sets or complex
data structures.
• In clinical trial settings, Excel can be used for basic descriptive statistics, such
as calculating means and standard deviations.
• However, it may not be suitable for more advanced statistical analyses, such
as survival analysis, meta-analysis, or Bayesian statistics.
• Additionally, Excel does not provide the same level of data security and
audit trails as dedicated clinical trial software.
• Excel Data Analysis Tools Excel‘s Analysis ToolPak is a helpful add-in
that provides an extensive set of statistical analysis tools.
• Some of the tools in the ToolPak are Anova: Single Factor, Anova: Two
Factor with and without Replication, Correlation, Covariance,
Descriptive Statistics etc.
Advantages of Using Excel for
Statistical Analysis:
• One of the biggest benefits of Excel is its ability to organize large
amounts of data into orderly, logical spreadsheets and charts. With
the data organized, it's a lot easier to analyze and digest, especially
when used to create graphs and other visual data representation.
• The formulas and equations are used to quickly compute both simple
and complex equations using large amounts of data.
• Excel is essentially considered the standard for spreadsheet software
and as such enjoys considerable support on a number of platforms.
Disadvantages of Using Excel for
Statistical Analysis
• Although excel is easy users unfamiliar with Excel syntax may also find entering
calculations and calling up other functions a bit frustrating until they get a solid
understanding.
• While Excel's automatic calculation functions make most large-scale batch
calculations easy, it isn't foolproof. Excel has no means of checking for human
error during data entry, which means that the wrong information can skew all
the results.
• Manually entering data into Excel can take a very long time -- especially if
there is a lot of data to enter. The amount of time it takes to manually enter
data can be extremely inefficient.
• Until Excel 2003, there are significant errors in statistical calculations
performed using excel.
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excel
SPSS (Statistical Package for
the Social Sciences)
• SPSS (Statistical Package for the Social Sciences) is a widely used
statistical software package that is popular in both industrial and
clinical trial settings.
• This program can be used to analyze data collected from surveys,
tests, observations, etc.
• It can perform a variety of data analyses and presentation functions,
including statistical analysis and graphical presentation of data.
Features
(1) descriptive statistics such as frequencies, central tendency, plots,
charts, and lists; and
(2) sophisticated inferential and multivariate statistical procedures such
as analysis of variance (ANOVA), factor analysis, cluster analysis, and
categorical data analysis.
The following Statistics are included
in the SPSS base software:
1. Descriptive statistics: Cross tabulation, Frequencies, Explore,
Descriptive Ratio Statistics
2. Bivariate statistics: Means, t-test, ANOVA, Correlation (bivariate,
partial, distances), Non parametric tests, Bayesian
3. Prediction for numerical outcomes: Linear Regression.
4. Prediction for identifying groups: Factor analysis, cluster analysis
(two-step, K-means, hierarchal), Discriminant.
5. Geospatial analysis, simulation.
6. R extension(GUI).
• In industrial settings, SPSS can be used for various purposes, such as quality
control, process improvement, and market research. For example, it can be
used to analyze customer feedback surveys to identify areas for improvement
in products or services.
• It can also be used to analyze manufacturing data to identify process
inefficiencies and areas for improvement.
• In clinical trials, SPSS is often used to analyze data from medical research
studies. It can be used to perform various types of statistical analysis, such as
descriptive statistics, inferential statistics, and regression analysis.
• For example, it can be used to analyze data from a randomized controlled trial
to evaluate the effectiveness of a new medication or treatment.
• SPSS can also be used for data management tasks, such as data cleaning, data
transformation, and data integration. This can help ensure the accuracy and
completeness of the data being analyzed.
Advantages:
• SPSS is a comprehensive statistical software which can be used for
both simple and complex analysis.
• Many statistical tests are available as a built in feature in the program
which suits the needs of the research communities.
• Interpretation of results is relatively easy.
• It easily and quickly displays data tables.
• It can be expanded according to the need of the statistical analysis.
LIMITATIONS
• SPSS is a paid software and can be expensive for students requiring
limited use.
• Usually involves added training to completely exploit all the available
features.
• The graph features are not as simple as that of Microsoft Excel.
SPSS
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MINITAB
• Minitab is a statistics package developed at the Pennsylvania State
University by researchers Barbara F. Ryan, Thomas A. Ryan, Jr., and
Brian L. Joiner in 1972.
• It began as a light version of OMNITAB 80, a statistical analysis
program by NIST(National Institute of standards and technology, USA).
• It helps in automation of calculations and the creation of graphs,
allowing the user to focus more on the analysis of data and the
interpretation of results.
• MINITAB is a statistical software that is widely used in various fields,
including industrial and clinical trial settings.
• Industrial applications: MINITAB can be used in industrial settings to
perform statistical analysis on production data.
• For example, it can be used to perform statistical process control
(SPC) to monitor production processes and identify trends or patterns
that may indicate a problem.
• It can also be used to perform design of experiments (DOE) to
optimize production processes and identify the optimal combination
of input variables that result in the desired output.
• Clinical trial applications: MINITAB can be used in clinical trials to
analyze data from experiments and studies.
• For example, it can be used to perform hypothesis testing to
determine if a new treatment is effective compared to a control
group.
• It can also be used to perform regression analysis to identify
predictors of outcomes, or survival analysis to analyze time-to-event
data.
Advantages of Minitab
• It is easy to use with lesser curve for learning.
• Minitab is a versatile statistics package that is cheaper and requires
less disk space than its heavyweight competitors like SPSS.
• It can be easily expanded according to the statistical needs.
Disadvantages of Minitab
• Limited Range of Functions: The range of statistical
analyses that Minitab can perform straight after installation
is not as wide as in other packages such as SPSS and SAS.
• This means that for applied research fields with specialized or
more rarely used techniques, such as economics or
bioinformatics, Mintab is not the ideal choice because such
analyses would have to be programmed into Minitab manually
using the macro system. Although the macro language is
powerful, this is time-consuming for complex procedures.
Disadvantages of Minitab
• Fixed structure: Although Minitab is generally considered
easy to use, and operates through an interface that is
intuitive to anyone familiar with other statistics packages, it
does suffer from some drawbacks in this area.
• Like the SPSS data view, the worksheet window in Minitab uses a
fixed structure that is more difficult to manipulate than in
spreadsheet programs like Microsoft Excel. Also, Minitab has poor
compatibility with other statistics programs, making file imports
more difficult.
Disadvantages of Minitab
• Lesser Popularity in Industry: One disadvantage of Minitab is that it is not as
widely used in industry as other packages.
• This means that businesses that use Minitab as their primary analysis package are
more likely to come across compatibility issues when using data from outside
sources.
• This makes Minitab a poor choice for organizations that may need to combine
data from multiple sources.
Disadvantages of Minitab
• Weak Mathematics Features: Minitab is primarily a
statistical analysis package, and as such is a weaker choice
for pure mathematical uses, with less ability to perform
mathematical and numerical analyses, at least not without
the use of custom macros. Similar packages outperform
Minitab in this area.
Conclusion
• In both industrial and clinical trial settings, MINITAB offers a user-
friendly interface for data entry and analysis, as well as a wide range
of statistical tools and tests that are commonly used in these fields.
Additionally, MINITAB provides graphical output to aid in the
interpretation of results, making it a valuable tool for decision-making
and problem-solving in these contexts.
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Design of experiments (DOE)
• Design of experiments (DOE) is a statistical tool that is widely used in
industrial and clinical trial settings.
• The main purpose of DOE is to determine the cause-and-effect
relationships between different variables and their impact on the
outcome of a process or experiment.
• Design of experiments can be carried out using a Design Expert which is a
software designed to help with the design and interpretation of multi-factor
experiments.
• In pharmaceutical tablet processing, we might use the software to help us
design an experiment to see how a property such as tensile strength varies
with changes in the processing conditions - e.g. changes in rotor speed or
die pressure.
• The software offers a wide range of designs, including factorials, fractional
factorials and composite designs.
• It can handle both process variables, such as rotor speed, and also mixture
variables, such as the proportion of resin in a plastic compound.
• Design Expert offers computer generated D-optimal designs for cases where
standard designs are not applicable, or where we wish to augment an
existing design - for example, to fit a more flexible model.
• In an industrial setting, DOE can be used to optimize and improve
manufacturing processes by identifying critical process parameters
and their optimal values.
• For example, in a chemical manufacturing process, DOE can be used
to determine the optimal temperature, pressure, and reaction time to
maximize the yield of the desired product.
• DOE can also be used to identify potential sources of variation and to
develop robustness tests to ensure that the process remains stable
and within specifications.
• In clinical trials, DOE can be used to design experiments that test the
efficacy and safety of new drugs or medical treatments.
• DOE can be used to identify the optimal dose and dosage schedule,
the most appropriate patient population, and the best combination of
treatments.
• DOE can also be used to identify potential sources of bias and to
control for confounding variables.
• In both industrial and clinical trial settings, DOE can be used to reduce
the number of experiments needed to achieve a desired outcome,
thus saving time and resources.
• DOE can also help to identify the most important factors affecting the
outcome of the process or experiment, allowing for more efficient
and effective decision-making.
Advantages
• Offers wide collection of experimental designs which can be used as it
is or can be custom designed according to one‘s own needs.
• It is flexible as well as expandable.
• Widely accepted in industry.
• Offers a real time prediction values with greater control on the
experimental parameters.
Disadvantages
• It is expensive.
• Requires adequate training to prevent errors in interpretation and
usage.
Conclusion
• The use of DOE as a statistical software in industrial and clinical trial
settings can provide significant benefits, such as improved process
efficiency, reduced costs, and increased reliability of experimental
results.
R
• R is a popular programming language and statistical software that can be
used in various fields including industrial and clinical trial approaches.
• Ross Ihaka and Robert Gentleman developed R as a free software
environment for their teaching classes when they were colleagues at the
University of Auckland in New Zealand.
• Because they were both familiar with S, a programming language for
statistics, it seemed natural to use similar syntax in their own work Ross
Ihaka wrote a comprehensive overview of the development of R.
• The web page
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provides a brief history about R.
• R provides a wide array of functions to help you with statistical
analysis with R—from simple statistics to complex analyses.
• Several statistical functions are built into R and R packages.
• R statistical functions fall into several categories including central
tendency and variability, relative standing, t-tests, analysis of variance
and regression analysis.
• In the industrial setting, R can be used for statistical process control,
quality control, and data analysis.
• R can be used to perform statistical tests and analysis on production
data to identify patterns and trends, and to determine if a process is
stable and capable of meeting specifications.
• R can also be used for experimental design and optimization to
improve production processes and reduce costs.
• In the clinical trial setting, R can be used for data management,
statistical analysis, and visualization of results.
• R can be used to perform various statistical tests such as hypothesis
testing, regression analysis, survival analysis, and Bayesian analysis.
• R also provides tools for data visualization which can help in the
interpretation and communication of results.
• Moreover, R is a cost-effective solution for data analysis in both
industrial and clinical trial settings as it is an open-source software
that can be downloaded and used for free.
• Additionally, R has a vast library of packages that can be used for
specific statistical analysis, making it a versatile tool for data analysis.
Advantages of R
• R is free. R is open-source and runs on UNIX, Windows and Macintosh.
• R has an excellent built-in help system.
• R has excellent graphing capabilities.
• One can easily migrate to the commercially supported S-Plus program if
commercial software is desired.
• R's language has a powerful, easy to learn syntax with many built-in statistical
functions.
• The language is easy to extend with user-written functions.
• R is a computer programming language. For programmers it will feel more
familiar than others and for new computer users, the next leap to
programming will not be so large.
Disadvantages of R:
• It has a limited graphical interface which can be harder to learn at the
outset.
• There is no commercial support.
• The command language is a programming language so it is necessary
to appreciate syntax issues etc.
Conclusion
• R can be a powerful tool for statistical analysis in industrial and clinical
trial settings.
• It provides a cost-effective solution for data analysis and has a wide
range of applications, making it a versatile and valuable tool for
researchers and practitioners in various fields.
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Design of experiments
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