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Related Experiment Videos

Assessing general side effects in clinical trials: reference data from the general population.

Winfried Rief¹, Arthur J Barsky, Julia A Glombiewski

¹University of Marburg, Germany. rief@staff.uni-marburg.de

Pharmacoepidemiology and Drug Safety

|March 29, 2011

Summary

A new structured method, the General Assessment of Side Effects (GASE), improves the detection of drug side effects. It provides population data to better interpret clinical trial results on adverse events.

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Area of Science:

Pharmacovigilance
Clinical Trial Methodology
Patient-Reported Outcomes

Background:

Clinical trials often assess side effects using unstructured methods lacking clear quality standards.
This can lead to underpowered studies and difficulties in interpreting adverse event data.

Purpose of the Study:

To introduce and validate a structured approach for assessing general side effects in clinical trials, termed the General Assessment of Side Effects (GASE).
To provide base rates and reference data from the general population for improved interpretation of clinical trial side effect assessments.

Main Methods:

Development of a screener for common subjective side effects based on FDA statistics and other sources.
Evaluation of the screener in a general population survey of 2512 participants, with 1276 individuals reporting drug use.

Main Results:

Reference data for the general population were established to aid in comparing clinical trial results.
Users of psychopharmacological drugs reported the highest side effect scores, followed by users of antihypertensives, lipid-lowering drugs, pain killers, and antidiabetics.
Polypharmacy (use of multiple drugs) was associated with a higher incidence of reported side effects, confirming GASE's validity.

Conclusions:

A structured, patient-based assessment of general side effects can enhance the detection of drug-induced adverse events.
Implementing reliable approaches like GASE can mitigate the issue of clinical studies being underpowered for side effect detection.
The study advocates for sophisticated methods for expected side effects, systematic screening for general side effects, and open methods for spontaneous reports.