Quality in Clinical Trials

Pros (Improved Quality and Adherence)

Improved Data Quality: Reduces measurement error and bias related to subject self-reporting, leading to a more accurate dose-response assessment and stronger evidence for drug efficacy and safety.

Enhanced Internal Validity: If a drug appears ineffective, objective adherence data can distinguish between true drug failure and subject non-adherence. This is crucial for regulatory decisions.

Targeted Intervention: Provides real-time or near real-time data, allowing research teams to identify non-adherent subjects early and offer targeted support or counseling, thereby genuinely improving adherence during the trial.

Smaller Sample Sizes: Higher quality, less-variable data may require smaller sample sizes to achieve the necessary statistical power, potentially reducing the cost and duration of the trial.

Sample Answer

Yes, I believe that increasing compliance monitoring and accurately detecting drug intake using objective methods is an appropriate tool to improve the quality of data and subject adherence in clinical trials.

This is primarily because it addresses the significant issue of information bias and enhances the internal validity of the study results.

🔬 Explanation and Rationale

Subject self-reporting of medication adherence (e.g., using diaries or questionnaires) is notoriously unreliable due to recall bias and the desire for subjects to be perceived as compliant (social desirability bias). Using objective tools provides a more precise and verifiable measure of the independent variable (drug exposure), which is essential for determining the true effect of the drug (the dependent variable).