Application of online statistical tools in industrial and clinical trials MCQs With Answer

This concise guide introduces B. Pharm students to the application of online statistical tools in industrial and clinical trials. Emphasizing sample size calculation, power analysis, randomization, blinding, p-values, confidence intervals, survival analysis, interim analysis and multiplicity adjustments, it explains how calculators and web-based platforms (G*Power, OpenEpi, GraphPad, ClinCalc, R/Shiny apps) support protocol design, data monitoring, and result interpretation. Practical use of t-tests, ANOVA, chi-square, nonparametric tests, logistic and Cox regression and sample size software is highlighted for real-world trial settings. The focus is on interpreting outputs, avoiding common pitfalls, and integrating tools into Good Clinical Practice. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which online tool is widely used for sample size and power calculations in clinical trials?

• GraphPad Prism
• G*Power
• OpenEpi
• ClinCalc

Correct Answer: G*Power

Q2. What is the primary purpose of performing a priori sample size calculation?

• To choose the best statistical test after collecting data
• To ensure sufficient power to detect a prespecified effect size
• To guarantee a statistically significant result
• To reduce study costs regardless of variability

Correct Answer: To ensure sufficient power to detect a prespecified effect size

Q3. Which statistical test is most appropriate for comparing means of two independent groups when data are normally distributed?

• Paired t-test
• Independent (unpaired) t-test
• Mann–Whitney U test
• Chi-square test

Correct Answer: Independent (unpaired) t-test

Q4. Which test should be used for comparing proportions between two independent groups?

• T-test
• Chi-square test
• ANOVA
• Kruskal–Wallis test

Correct Answer: Chi-square test

Q5. In survival analysis, which method estimates the probability of event-free survival over time?

• Logistic regression
• Cox proportional hazards model
• Kaplan–Meier estimator
• ANOVA

Correct Answer: Kaplan–Meier estimator

Q6. What does a hazard ratio (HR) less than 1 indicate in a clinical trial survival analysis?

• Increased hazard in treatment group
• No difference between groups
• Reduced hazard (risk) in treatment group
• Invalid proportional hazards assumption

Correct Answer: Reduced hazard (risk) in treatment group

Q7. Which online feature helps check assumptions for parametric tests (e.g., normality)?

• Randomization module
• Normality tests and Q-Q plots
• Interim analysis calculator
• Multiplicity correction tool

Correct Answer: Normality tests and Q-Q plots

Q8. For non-normally distributed continuous data comparing two independent groups, which test is preferred?

• Independent t-test
• Mann–Whitney U test
• Repeated measures ANOVA
• Chi-square test

Correct Answer: Mann–Whitney U test

Q9. Which online calculator is especially useful for epidemiology measures such as relative risk and odds ratio?

• G*Power
• OpenEpi
• GraphPad Prism
• R base install only

Correct Answer: OpenEpi

Q10. What is the main risk of conducting multiple hypothesis tests without adjustment?

• Increased type II error (false negatives)
• Decreased sample size requirement
• Increased type I error (false positives)
• No impact on error rates

Correct Answer: Increased type I error (false positives)

Q11. Which adjustment method is simple but conservative for multiple comparisons?

• Holm–Bonferroni method
• Benjamini–Hochberg procedure
• Bonferroni correction
• False discovery rate (FDR)

Correct Answer: Bonferroni correction

Q12. What does a p-value represent?

• Probability the null hypothesis is true
• Probability of observing data as extreme or more if the null is true
• Effect size magnitude
• Clinical importance of findings

Correct Answer: Probability of observing data as extreme or more if the null is true

Q13. Which approach analyzes participants according to initial random assignment regardless of adherence?

• Per-protocol analysis
• As-treated analysis
• Intention-to-treat analysis
• Post-hoc subgroup analysis

Correct Answer: Intention-to-treat analysis

Q14. Which type of sample size calculation is used for noninferiority trials?

• Equivalence margin not required
• Calculation using a noninferiority margin
• Standard superiority sample size only
• Only descriptive statistics

Correct Answer: Calculation using a noninferiority margin

Q15. Which online tool provides interactive plotting and custom analyses via web apps often used in trials?

• Excel macros
• R/Shiny apps
• Paper calculators
• Simple calculators with no plotting

Correct Answer: R/Shiny apps

Q16. When planning a clinical trial, which parameter decreases required sample size if increased?

• Alpha (type I error)
• Effect size
• Desired power
• Outcome variance

Correct Answer: Effect size

Q17. Which method is used to compare survival curves between two groups?

• ANOVA
• Log-rank test
• T-test
• Fisher’s exact test

Correct Answer: Log-rank test

Q18. Which online concern is important when uploading trial data to web calculators?

• Only speed of calculation matters
• Data privacy and regulatory compliance
• Web calculators always provide regulatory approval
• No concern if data are anonymized

Correct Answer: Data privacy and regulatory compliance

Q19. For assessing diagnostic test accuracy, which metric combines sensitivity and specificity trade-offs?

• Kaplan–Meier curve
• ROC curve and AUC
• Pearson correlation
• Bland–Altman plot

Correct Answer: ROC curve and AUC

Q20. What is Cohen’s d used to express?

• Proportion difference
• Standardized mean effect size
• Hazard ratio
• P-value adjustment factor

Correct Answer: Standardized mean effect size

Q21. Which online test helps examine association between two categorical variables when expected counts are small?

• Chi-square test without correction
• Fisher’s exact test
• T-test
• Mann–Whitney U test

Correct Answer: Fisher’s exact test

Q22. Which analysis adjusts for baseline covariates to reduce residual variance and improve power?

• ANOVA without covariates
• ANCOVA
• Kaplan–Meier method
• Simple regression with only outcome

Correct Answer: ANCOVA

Q23. What does interim analysis primarily address in long clinical trials?

• Final sample size reduction only
• Early stopping for efficacy, harm, or futility
• Replacing lost subjects
• Increasing alpha without adjustment

Correct Answer: Early stopping for efficacy, harm, or futility

Q24. Which stopping boundary is conservative early but allows easier stopping later in interim analyses?

• Pocock boundary
• Haybittle–Peto rule
• O’Brien–Fleming boundary
• Bonferroni correction

Correct Answer: O’Brien–Fleming boundary

Q25. Which regression model is appropriate for a binary outcome in clinical trials?

• Cox proportional hazards model
• Linear regression
• Logistic regression
• Poisson regression only

Correct Answer: Logistic regression

Q26. What is censoring in survival analysis?

• Removing outliers before analysis
• Subjects lost to follow-up or without event by study end
• Adjusting p-values for multiplicity
• Transforming variables to normality

Correct Answer: Subjects lost to follow-up or without event by study end

Q27. Which measure quantifies the smallest change considered clinically important?

• Effect size only
• Minimal clinically important difference (MCID)
• P-value threshold
• Standard error

Correct Answer: Minimal clinically important difference (MCID)

Q28. Which randomization method helps ensure balance across treatment groups within strata?

• Simple randomization only
• Block randomization with stratification
• Convenience allocation
• Allocation by patient preference

Correct Answer: Block randomization with stratification

Q29. Which online tool is user-friendly for basic biostatistics and graphs commonly used in pharmaceutical research?

• GraphPad Prism
• Command-line only R with no GUI
• Text editor
• Basic calculator with no graphing

Correct Answer: GraphPad Prism

Q30. What is a key limitation when relying solely on online statistical calculators for trial analysis?

• They always produce unbiased results
• They replace need for statistical expertise
• Potential misuse due to unverified assumptions and lack of context
• They are universally accepted by regulators without documentation

Correct Answer: Potential misuse due to unverified assumptions and lack of context

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