Peer-Reviewed Publications

    Intention-to-treat analysis but for treatment intention: How should consumer product randomized controlled trials be analyzed?

    Weitkunat, R.; Baker, G.; Lüdicke, F.
    Published
    Jun 2, 2016
    DOI
    10.6000/1929-6029.2016.05.02.3
    Link to publication
    Topic
    Summary

    Background: Experimental study design, randomization, blinding, control, and the analysis of such data according to the intention-to-treat (ITT) principle are de-facto “gold standards” in pharmacotherapy research. While external treatment allocation under conditions of medical practice is conceptually reflected by in-study randomization in randomized controlled trials (RCTs) of therapeutic drugs, actual product use is based on self-selection in a consumer product setting. Discussion: With in-market product allocation being consumer-internal, there is no standard against which protocol adherence can be attuned, and the question arises, as to whether compliance-based analysis concepts reflect the real-world effects of consumer products. Summary: The lack of correspondence between RCTs and consumer market conditions becomes evident by the fact that even if, theoretically, all data would be available from all members of the real-world target population, it would be impossible to calculate either an ITT or a per-protocol effect. This renders the calculation of such estimates meaningless in consumer product research contexts.

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