Analysis of Multiple End Points in Consumer Research in Support of Switching Drugs From Prescription to Over-the-Counter Status: The Concept of End-Point Hierarchies

Clinical and regulatory decision making concerning over‐the‐counter (OTC) drugs requires research designed to understand how consumers will self‐manage treatment using the candidate OTC drug. Consumer research for an OTC drug may include studies of label comprehension, self‐selection, and actual use...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Clinical pharmacology and therapeutics 2009-04, Vol.85 (4), p.369-374
Hauptverfasser: Brass, EP, Shay, LE, Leonard‐Segal, A
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung:Clinical and regulatory decision making concerning over‐the‐counter (OTC) drugs requires research designed to understand how consumers will self‐manage treatment using the candidate OTC drug. Consumer research for an OTC drug may include studies of label comprehension, self‐selection, and actual use. Definition and analysis of end points for these trials have varied in the absence of consensus on optimal approaches. Research programs should prospectively prioritize the importance of label messages based on their roles in the safe and effective use of the drug. The assessment of messages for which failure to heed warnings will expose the consumer to increased risk or clinically relevant treatment failure should receive the highest priority as study end points. Based on the consequences of unheeded warnings, message‐specific targets for appropriate response rates can be predefined. This prospective, hierarchical approach to end‐point definition, combined with prespecification of targeted correct‐response rates, has the potential to increase the scientific rigor and regulatory utility of these important research studies. Clinical Pharmacology & Therapeutics (2009); 85, 4, 369–374 doi:10.1038/clpt.2008.254
ISSN:0009-9236
1532-6535
DOI:10.1038/clpt.2008.254