Why do pilot trials face obstacles in providing reliable safety and tolerability

Question

Why do pilot trials face obstacles in providing reliable safety and tolerability data?

The 95% confidence interval is too stringent in a pilot.

Participants in a pilot may neglect to report an adverse event or a tolerability concern.

Adverse events that are rare may go undetected because of small sample size.

Systems to detect adverse events are less likely to be in place than in a full-scale trial.

The 95% confidence interval is too stringent in a pilot.

Participants in a pilot may neglect to report an adverse event or a tolerability concern.

Adverse events that are rare may go undetected because of small sample size.

Systems to detect adverse events are less likely to be in place than in a full-scale trial.

Explanation / Answer

Pilot studies represent a fundamental phase of the research process. The purpose of conducting a pilot study is to examine the feasibility of an approach that is intended to be used in a larger scale study.

A pilot study is not a hypothesis testing study. Contrary to tradition, a pilot study does not provide a meaningful effect size estimate for planning subsequent studies due to the imprecision inherent in data from small samples. Adverse events undetected, primarily due to the small sample size involved, the short du ration of these pilot studies.

Correct option: C. Adverse events that are rare may go undetected because of small sample size.

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