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Biostatistics 10 Marks Answers

The document discusses various statistical tests, differentiating between parametric and non-parametric tests, and outlines their assumptions, examples, and advantages. It also explains statistical software SPSS and MINITAB, clinical design principles, design and analysis of experiments, and the differences between experimental and observational studies. Additionally, it lists clinical trial software and provides details on OpenClinica and GraphPad Prism.

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akshaychavan762002
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35 views7 pages

Biostatistics 10 Marks Answers

The document discusses various statistical tests, differentiating between parametric and non-parametric tests, and outlines their assumptions, examples, and advantages. It also explains statistical software SPSS and MINITAB, clinical design principles, design and analysis of experiments, and the differences between experimental and observational studies. Additionally, it lists clinical trial software and provides details on OpenClinica and GraphPad Prism.

Uploaded by

akshaychavan762002
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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05-Mark Question Answers

Biostatistics and Research Methodology


a) Differentiate between Parametric and Non-Parametric Tests (CO3)

Parametric Tests:
Parametric tests are statistical tests that make assumptions about the parameters of the
population distribution from which the sample is drawn. These tests typically assume that
the data follows a normal distribution and that the data is measured at an interval or ratio
scale.

Assumptions:
- Normal distribution of data.
- Homogeneity of variances.
- Interval or ratio level of measurement.

Examples:
- t-tests (one-sample, independent, paired)
- Analysis of Variance (ANOVA)
- Pearson correlation
- Regression analysis

Advantages:
- More powerful and precise if assumptions are met.
- Allow estimation of confidence intervals.

Non-Parametric Tests:
Non-parametric tests do not assume any specific distribution. They are used when the
data does not meet the assumptions required for parametric tests, such as small sample
sizes, ordinal data, or skewed distributions.

Assumptions:
- Distribution-free (no assumptions of normality).
- Can be used on ordinal or nominal data.

Examples:
- Chi-square test
- Mann-Whitney U test
- Kruskal-Wallis test
- Wilcoxon Signed Rank test

Advantages:
- Flexible.
- Useful for non-normal data and small sample sizes.

Key Differences:

| Criteria | Parametric Tests | Non-Parametric Tests |


|--------------------------|-------------------------------------|-----------------------------------|
| Distribution Assumption | Normal distribution | No distribution assumption
|
| Data Type | Interval or ratio | Ordinal or nominal |
| Power | More powerful when assumptions met | Less powerful but robust
|
| Examples | t-test, ANOVA | Chi-square, Mann-Whitney,
Wilcoxon |
(Page 81)

b) What is SPSS and MINITAB? (CO1)

SPSS (Statistical Package for the Social Sciences):


SPSS is one of the most widely used programs for statistical analysis in social science.
Originally developed by IBM, it is now used in a wide range of disciplines, including
medical and pharmaceutical research, marketing, and health sciences.

Features:
- User-friendly graphical interface.
- Performs descriptive statistics, cross-tabulation, regression, ANOVA, and more.
- Allows importing of data from Excel, SQL databases, and other formats.
- Includes features for data visualization like bar charts, histograms, and scatterplots.

Advantages:
- Easy to use without much programming.
- Suitable for both beginners and advanced users.
- Extensive documentation and support.

MINITAB:
Minitab is another statistical software package used primarily for quality improvement,
Six Sigma, and teaching statistics. It is known for its simplicity and powerful analytical
tools.

Features:
- Tools for statistical analysis such as hypothesis testing, regression, and ANOVA.
- Quality tools like control charts, capability analysis, and process improvement.
- Graphical analysis tools including Pareto charts and boxplots.

Advantages:
- Ideal for industrial and business applications.
- Integrates well with quality management processes.
- Offers tutorials and an assistant feature for guided analysis.
(Page 133)

c) Explain in Detail Clinical Design (CO5)

Clinical design refers to the structured plan and methodology for conducting clinical
research or trials. It ensures that the collected data are reliable, unbiased, and
scientifically valid for drawing conclusions about the effectiveness or safety of a
treatment.

Key Components of Clinical Design:


1. Blinding:
- Single-blind: Participants are unaware of the treatment group.
- Double-blind: Both researchers and participants are unaware.
- Triple-blind: Patients, investigators, and analysts are unaware.

2. Randomization:
- Reduces selection bias.
- Ensures equal distribution of confounding variables.

3. Control Groups:
- Helps in comparing treatment effects.
- May use placebo or standard treatment.

4. Study Designs:
- Parallel Design: Two or more groups receive different treatments simultaneously.
- Crossover Design: Participants receive treatments in a sequential manner after a
washout period.
- Factorial Design: Examines the effects of multiple interventions in one study.
- Cluster Design: Groups rather than individuals are randomized.

Objectives of Clinical Designs:


- Minimize bias and variability.
- Improve the reliability of the results.
- Enable statistical analysis for decision-making.

Ethical Considerations:
- Informed consent.
- Ethical clearance.
- Safety monitoring.
(Pages 109–110)

d) Explain Design and Analysis of Experiments (CO5)

Design of Experiments (DOE) is a systematic method used to determine the relationship


between factors affecting a process and the output of that process. It is extensively used
in pharmaceutical and industrial research.

Key Concepts:

1. Objective of DOE:
- To find cause-and-effect relationships.
- To optimize a process or product.

2. Elements of DOE:
- Factors: Variables that are controlled or changed.
- Levels: The settings or values of factors.
- Response: The outcome or result being measured.

3. Types of Designs:
- Completely Randomized Design (CRD): Each experimental unit is randomly assigned
a treatment.
- Randomized Block Design (RBD): Blocks are formed to group similar experimental
units.
- Latin Square Design: Used when two blocking variables need to be controlled.
4. Analysis:
- Use of ANOVA to assess whether the factor has a significant effect.
- Post-hoc tests to compare means.
- Regression analysis for modeling relationships.

5. Benefits:
- Improves quality and productivity.
- Reduces variation.
- Enables prediction and optimization.
(Pages 117–120)

e) Describe Experimental and Observational Studies (CO5)

Experimental Studies:
In these studies, the researcher manipulates one or more variables (independent variables)
to determine their effect on an outcome (dependent variable). These are also known as
interventional studies.

Features:
- Random assignment to groups.
- Presence of a control group.
- Often uses blinding and randomization.

Example: A clinical trial where patients are given a new drug vs. placebo.

Observational Studies:
In observational studies, the researcher does not intervene but merely observes the
relationship between variables.

Types:
- Cohort Study: Follows a group over time to assess outcomes.
- Case-Control Study: Compares patients with a condition (cases) to those without
(controls).
- Cross-Sectional Study: Data is collected at a single point in time.

Features:
- No manipulation or intervention.
- Less costly and time-consuming.
- Prone to bias and confounding factors.
Comparison:

| Aspect | Experimental Study | Observational Study |


|---------------------|--------------------------|--------------------------|
| Intervention | Yes | No |
| Randomization | Yes | Usually No |
| Bias | Reduced | Higher risk |
| Time and Cost | More | Less |
| Causality | Strong evidence | Association only |
(Pages 106–108)

f) Enlist Clinical Trial Software and Explain Any Two (CO1)

List of Clinical Trial Software:


- SPSS
- MINITAB
- R Programming
- SAS
- GraphPad Prism
- OpenClinica
- Medidata
- Clintrial

Explanation of Two:

1. OpenClinica:
- Open-source clinical trial software used for electronic data capture (EDC).
- Used by research organizations and hospitals to design case report forms (CRFs),
manage subject data, and monitor trial progress.
- Features include audit trails, data validation, and secure login.
- Complies with regulatory standards like FDA 21 CFR Part 11.

2. GraphPad Prism:
- Combines scientific graphing, comprehensive curve fitting, and statistical analysis.
- User-friendly for life sciences researchers.
- Offers pre-set templates and step-by-step analysis guides.
- Used in pharmacology, physiology, and biochemistry studies.
(Page 133)

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