Practical difficulties in research MCQs With Answer

Practical difficulties in research MCQs With Answer

This quiz set focuses on practical challenges commonly encountered in pharmaceutical research and clinical studies, tailored for M.Pharm students. It covers real-world issues such as recruitment barriers, ethical and regulatory delays, measurement challenges, data management, instrument calibration, adherence and follow-up problems, multicenter variability, and statistical consequences of practical constraints. Each question is designed to deepen understanding of how operational difficulties affect study validity, bias, power, and interpretation, and to highlight practical mitigation strategies. Use these MCQs to test readiness for designing, conducting, and troubleshooting rigorous pharmacological and clinical research projects.

Q1. Which of the following practical problems most directly causes a study to become underpowered despite correct sample size calculation?

• Small expected effect size assumed during planning
• Low participant recruitment resulting in insufficient sample size
• Use of an unreliable measurement instrument
• Presence of confounding variables

Correct Answer: Low participant recruitment resulting in insufficient sample size

Q2. When many participants are illiterate, the ethically appropriate practical approach to obtain informed consent is:

• Proceed with implied consent without documentation
• Obtain a witnessed oral consent with documentation or audio-recording
• Use a short consent form without explanation
• Skip consent if the study is low risk

Correct Answer: Obtain a witnessed oral consent with documentation or audio-recording

Q3. High loss to follow-up in a longitudinal drug trial most commonly introduces which type of bias?

• Selection bias
• Attrition bias
• Observer bias
• Publication bias

Correct Answer: Attrition bias

Q4. Repeated measurements that produce inconsistent results reflect a problem of:

• Validity
• Reliability
• Sensitivity
• Specificity

Correct Answer: Reliability

Q5. A common practical consequence of prolonged ethics committee and regulatory approvals is:

• Improved study quality due to extra review time
• Reduced recruitment period and possible budget overruns
• Guaranteed increase in sample size
• Automatic extension of study timelines without cost

Correct Answer: Reduced recruitment period and possible budget overruns

Q6. In trials where blinding is not feasible (e.g., surgery vs. drug), the primary risk introduced is:

• Selection bias
• Performance bias
• Detection bias
• Reporting bias

Correct Answer: Performance bias

Q7. To account for systematic differences among participating centers in a multicenter trial, the appropriate analytic approach is:

• A fixed-effects model ignoring center variation
• A mixed-effects (random-effects) model accounting for center variability
• Pooling data without adjustment
• Simple subgroup analysis only

Correct Answer: A mixed-effects (random-effects) model accounting for center variability

Q8. If the probability that a data value is missing depends only on observed data and not on the missing value itself, the missingness mechanism is called:

• Missing completely at random (MCAR)
• Missing at random (MAR)
• Missing not at random (MNAR)
• Deterministic missingness

Correct Answer: Missing at random (MAR)

Q9. When many assay results fall below the laboratory limit of detection, the common statistical description for such censoring is:

• Right-censoring
• Left-censoring
• Interval-censoring
• No censoring

Correct Answer: Left-censoring

Q10. The principal purpose of conducting a pilot study before a full-scale clinical trial is to:

• Test the primary hypothesis definitively
• Estimate feasibility, recruitment rates, and refine the protocol
• Replace the need for a larger trial
• Obtain regulatory approval in place of the main study

Correct Answer: Estimate feasibility, recruitment rates, and refine the protocol

Q11. The best practical step to protect participant confidentiality when sharing study data is to:

• Publish the dataset without identifiers
• Use de-identification and strong encryption with controlled access
• Remove only names but keep other direct identifiers
• Rely on participant trust without technical safeguards

Correct Answer: Use de-identification and strong encryption with controlled access

Q12. When should investigators disclose financial conflicts of interest to minimize practical problems in research conduct?

• Only at the time of manuscript submission
• Only during participant recruitment
• At funding application and again during manuscript submission
• No disclosure is necessary if managed internally

Correct Answer: At funding application and again during manuscript submission

Q13. Instrument calibration drift that causes systematic measurement error is best prevented by which routine practice?

• Calibration only at initial installation
• Periodic calibration and routine quality control (QC) checks
• Recalibration only when values look implausible
• Ignoring minor drifts because they average out

Correct Answer: Periodic calibration and routine quality control (QC) checks

Q14. To overcome cultural and language barriers in patient-reported outcome measures, the recommended approach is:

• Administer the original language version only
• Translate and back-translate the instrument and pilot test the translation
• Use ad hoc verbal translation at the site without validation
• Exclude non-native speakers from the study

Correct Answer: Translate and back-translate the instrument and pilot test the translation

Q15. In randomized controlled trials with non-adherence, which analysis strategy best preserves the benefits of randomization?

• Per-protocol analysis
• As-treated analysis
• Intention-to-treat (ITT) analysis
• Subgroup analysis of adherent participants only

Correct Answer: Intention-to-treat (ITT) analysis

Q16. If budget constraints threaten planned sample size during a trial, a practical mitigation strategy is to:

• Reduce monitoring and quality control to save costs
• Use adaptive sample size re-estimation or seek additional funding
• Change the primary endpoint after data collection starts
• Exclude difficult-to-recruit subgroups permanently

Correct Answer: Use adaptive sample size re-estimation or seek additional funding

Q17. A frequent practical regulatory challenge in multinational drug trials is:

• Uniform IRB timelines across all countries
• Differences in national regulatory requirements and approval processes
• Too few regulatory authorities to review large trials
• Identical informed consent requirements everywhere

Correct Answer: Differences in national regulatory requirements and approval processes

Q18. When individual-level contamination between treatment arms is likely (e.g., patients exchange medication), the trial design change to minimize contamination is:

• Increase blinding only
• Adopt cluster randomization by site or group
• Switch to a crossover design
• Use smaller sample size

Correct Answer: Adopt cluster randomization by site or group

Q19. The most effective practical data-entry method to reduce transcription errors in clinical trial datasets is:

• Single manual data entry without checks
• Double data entry with discrepancy resolution and validation checks
• Entering data directly from paper without verification
• Using spreadsheets without data validation rules

Correct Answer: Double data entry with discrepancy resolution and validation checks

Q20. When a study tests multiple secondary outcomes without adjustment, the major statistical risk is increased chance of:

• Type II error (false negatives)
• Type I error (false positives) due to multiplicity
• Measurement bias
• Loss of external validity

Correct Answer: Type I error (false positives) due to multiplicity

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