Literature review and study design in preclinical research MCQs With Answer

Introduction

Effective preclinical research requires a solid literature review and robust study design. A focused literature review (systematic or narrative) identifies knowledge gaps, defines PICO, and informs choice of experimental models, controls, and endpoints. Strong study design covers randomization, blinding, sample size and power calculation, appropriate animal or in vitro models, ARRIVE guidelines, ethical approval and measures to reduce bias and improve reproducibility. Understanding statistical assumptions, effect size, replication, and data reporting enhances translational success and regulatory compliance for B. Pharm students preparing research projects. These concepts are essential for designing reliable experiments and critically appraising literature. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which type of literature review uses a predefined protocol, exhaustive search, and explicit inclusion criteria to minimize bias?

• Scoping review
• Systematic review
• Narrative review
• Integrative review

Correct Answer: Systematic review

Q2. In preclinical PICO frameworks, the ‘I’ most commonly stands for which element?

• Inclusion criteria
• Intervention
• In vivo model
• Independent variable

Correct Answer: Intervention

Q3. Which guideline specifically aims to improve reporting of animal research to enhance reproducibility?

• CONSORT
• PRISMA
• ARRIVE
• STROBE

Correct Answer: ARRIVE

Q4. What is the main purpose of randomization in preclinical experiments?

• Increase sample size
• Reduce selection bias and balance confounders
• Ensure blinding of investigators
• Standardize outcome measures

Correct Answer: Reduce selection bias and balance confounders

Q5. Which study design feature directly reduces observer-expectancy bias?

• Randomization
• Blinding
• Stratification
• Replication

Correct Answer: Blinding

Q6. The minimal experimental unit for statistical analysis in an animal study is:

• The individual animal or cage depending on allocation
• The technician performing the experiment
• The laboratory where the study is done
• The total number of observations

Correct Answer: The individual animal or cage depending on allocation

Q7. Which method is appropriate to calculate the number of animals needed to detect a predefined effect with acceptable power?

• Post hoc power analysis
• Sample size calculation using effect size, alpha, and power
• Using historical averages without calculation
• Selecting an arbitrary round number

Correct Answer: Sample size calculation using effect size, alpha, and power

Q8. In literature searches for preclinical reviews, which database is most commonly used for biomedical animal studies?

• PubMed/MEDLINE
• ERIC
• Scopus for humanities
• IEEE Xplore

Correct Answer: PubMed/MEDLINE

Q9. What does PRISMA primarily provide guidance on?

• Preclinical ethical approvals
• Reporting items for systematic reviews and meta-analyses
• Randomization techniques in animal studies
• Laboratory safety procedures

Correct Answer: Reporting items for systematic reviews and meta-analyses

Q10. Which control is used to demonstrate that the experimental system can detect a known effect?

• Negative control
• Vehicle control
• Positive control
• Sham control

Correct Answer: Positive control

Q11. Which is a primary ethical principle in animal research summarized by the “3Rs”?

• Randomize, Report, Reproduce
• Reduce, Replace, Refine
• Review, Register, Replicate
• Request, Release, Reuse

Correct Answer: Reduce, Replace, Refine

Q12. A narrative review differs from a systematic review mainly because it:

• Includes only randomized trials
• Uses a structured protocol to minimize bias
• Is more flexible and may lack an explicit search strategy
• Always includes meta-analysis

Correct Answer: Is more flexible and may lack an explicit search strategy

Q13. Which design is most efficient to study two factors and their interaction in a single preclinical experiment?

• Parallel group design
• Factorial design
• Crossover design
• Case-control design

Correct Answer: Factorial design

Q14. What is publication bias?

• Bias introduced by improper lab protocols
• Tendency to publish only positive or significant results
• Errors in statistical calculations
• Bias from not randomizing animals

Correct Answer: Tendency to publish only positive or significant results

Q15. Pre-registration of preclinical study protocols primarily helps to:

• Increase the number of animals used
• Prevent selective outcome reporting and increase transparency
• Replace the need for ethical approval
• Guarantee positive findings

Correct Answer: Prevent selective outcome reporting and increase transparency

Q16. Which is an example of an objective outcome measure in preclinical pharmacology?

• Investigator’s overall impression
• Biomarker concentration measured by ELISA
• Subjective pain score without scale
• Unstandardized behavioral note

Correct Answer: Biomarker concentration measured by ELISA

Q17. What does “internal validity” refer to in experimental studies?

• Generalizability to other species
• Accuracy of causal inference within the study
• Quality of external reporting
• Number of citations the study receives

Correct Answer: Accuracy of causal inference within the study

Q18. Which technique helps control for known confounders before treatment allocation?

• Blinding
• Stratified randomization
• Post hoc subgroup analysis
• Ignoring covariates

Correct Answer: Stratified randomization

Q19. A pilot study in preclinical research is primarily used to:

• Replace the main study
• Estimate parameters and feasibility to inform sample size
• Confirm definitive hypotheses
• Increase publication bias

Correct Answer: Estimate parameters and feasibility to inform sample size

Q20. Replication that repeats an experiment in a different lab to test generalizability is called:

• Direct replication
• Conceptual replication
• Internal replication
• Statistical replication

Correct Answer: Conceptual replication

Q21. Which statistical concept is the probability of correctly rejecting a false null hypothesis?

• Type I error (alpha)
• Confidence interval
• Power (1 – beta)
• P-value

Correct Answer: Power (1 – beta)

Q22. In preclinical meta-analysis, heterogeneity between studies is commonly quantified by:

• p-value only
• I-squared statistic
• Standard deviation of a single study
• Median effect

Correct Answer: I-squared statistic

Q23. Which factor is NOT typically part of assessing risk of bias in animal studies?

• Random sequence generation
• Blinding of outcome assessment
• Selective reporting of outcomes
• Color of the laboratory walls

Correct Answer: Color of the laboratory walls

Q24. Which outcome is most likely to improve external validity of preclinical findings?

• Using a single inbred strain under highly controlled conditions
• Testing across multiple species or strains
• Reducing variability by excluding males
• Only publishing significant results

Correct Answer: Testing across multiple species or strains

Q25. During data extraction for a systematic review, which piece of information is essential?

• Authors’ favorite color
• Outcome measures and numerical results
• Number of page references
• Journal impact factor only

Correct Answer: Outcome measures and numerical results

Q26. Which technique minimizes variability by grouping similar experimental units before randomization?

• Blocking
• Simple random sampling
• Convenience sampling
• Open-label assignment

Correct Answer: Blocking

Q27. A vehicle control in pharmacology experiments is used to:

• Test the active compound
• Control for effects of the solvent or delivery medium
• Replace positive control
• Blind the animals

Correct Answer: Control for effects of the solvent or delivery medium

Q28. Which reporting practice helps other researchers reproduce a preclinical experiment?

• Providing precise methods, reagents, and raw data
• Omitting negative results
• Describing methods only in general terms
• Sharing only summarized graphs

Correct Answer: Providing precise methods, reagents, and raw data

Q29. Confounding occurs when:

• An extraneous variable is associated with both exposure and outcome
• Randomization is perfectly executed
• Sample size is very large
• Only objective measures are used

Correct Answer: An extraneous variable is associated with both exposure and outcome

Q30. Which element is critical when choosing an in vitro model for translational preclinical research?

• Model relevance to human biology and the mechanism under study
• Cost only
• Availability of colorful reagents
• Using the simplest cell line regardless of relevance

Correct Answer: Model relevance to human biology and the mechanism under study

Download