Table 3
Open in new tab

Principles surrounding the collection and analysis of adherence for valid statistical analysis

  • Pre-specify the definition of adherence

  • Determine if adherence information will be collected in a static (at follow-up visits only) or in a dynamic fashion (throughout the study duration)

  • Profile occurrences of medication discontinuation at a minimum by:

    • Underlying reason;

    • Duration;

  • Pre-specify analytic plan for adherence

    • Sample size/power considerations

    • Must take into account primary trial hypothesis (efficacy vs. safety)

  • Pre-specify the different analytic sets, in particular the per-protocol population

  • Pre-specify the definition of adherence

  • Determine if adherence information will be collected in a static (at follow-up visits only) or in a dynamic fashion (throughout the study duration)

  • Profile occurrences of medication discontinuation at a minimum by:

    • Underlying reason;

    • Duration;

  • Pre-specify analytic plan for adherence

    • Sample size/power considerations

    • Must take into account primary trial hypothesis (efficacy vs. safety)

  • Pre-specify the different analytic sets, in particular the per-protocol population

Table 3
Open in new tab

Principles surrounding the collection and analysis of adherence for valid statistical analysis

  • Pre-specify the definition of adherence

  • Determine if adherence information will be collected in a static (at follow-up visits only) or in a dynamic fashion (throughout the study duration)

  • Profile occurrences of medication discontinuation at a minimum by:

    • Underlying reason;

    • Duration;

  • Pre-specify analytic plan for adherence

    • Sample size/power considerations

    • Must take into account primary trial hypothesis (efficacy vs. safety)

  • Pre-specify the different analytic sets, in particular the per-protocol population

  • Pre-specify the definition of adherence

  • Determine if adherence information will be collected in a static (at follow-up visits only) or in a dynamic fashion (throughout the study duration)

  • Profile occurrences of medication discontinuation at a minimum by:

    • Underlying reason;

    • Duration;

  • Pre-specify analytic plan for adherence

    • Sample size/power considerations

    • Must take into account primary trial hypothesis (efficacy vs. safety)

  • Pre-specify the different analytic sets, in particular the per-protocol population

Close
This Feature Is Available To Subscribers Only

Sign In or Create an Account

Close

This PDF is available to Subscribers Only

View Article Abstract & Purchase Options

For full access to this pdf, sign in to an existing account, or purchase an annual subscription.

Close