Clinical Trial Measure

A Clinical Trial Measure is a measure that is related to the quantification or classification of a test subject's clinical response to a medical intervention/treatment.

• Example(s):
  • a Clinical Trial Safety Measure (a clinical safety measure).
  • a Clinical Trial Efficacy Measure (a clinical efficacy measure).
  • a Clinical Trial Effectiveness Measure (a clinical effectiveness measure).
  • a Clinical Trial Therapeutic Adherence Measure (a therapeutic adherence measure) with clinical trial therapeutic adherence values, such as: underdosing.
  • a Clinical Trial Protocol Compliance Measure, such as an PRO compliance measure.
  • …
• Counter-Example(s):
  • Clinical Outcome Assessment (COA) Measure.
• See: Human Clinical Trial, Clinical Trial Phase, Adverse Event, Side Effect.

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References

2014

• (Vrijens & Urquhart, 2014) ⇒ Bernard Vrijens, and John Urquhart. (2014). “Methods for Measuring, Enhancing, and Accounting for Medication Adherence in Clinical Trials.” Clinical Pharmacology & Therapeutics 95, no. 6
  • ABSTRACT: Adherence to rationally prescribed medications is essential for effective pharmacotherapy. However, widely variable adherence to protocol-specified dosing regimens is prevalent among participants in ambulatory drug trials, mostly manifested in the form of underdosing. Drug actions are inherently dose and time dependent, and as a result, variable underdosing diminishes the actions of trial medications by various degrees. The ensuing combination of increased variability and decreased magnitude of trial drug actions reduces statistical power to discern between-group differences in drug actions. Variable underdosing has many adverse consequences, some of which can be mitigated by the combination of reliable measurements of ambulatory patients’ adherence to trial and nontrial medications, measurement-guided management of adherence, statistically and pharmacometrically sound analyses, and modifications in trial design. Although nonadherence is prevalent across all therapeutic areas in which the patients are responsible for treatment administration, the significance of the adverse consequences depends on the characteristics of both the disease and the medications.

2007

• (Lee et al., 2007) ⇒ Jeannie K. Lee, Karen A. Grace, Terri G. Foster, Monica J. Crawley, Goldina I. Erowele, Hazel J. Sun, Phuong T. Turner, Lance E. Sullenberger, and Allen J. Taylor. (2007). “[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2374934/

How Should We Measure Medication Adherence in Clinical Trials and Practice?]. ” Therapeutics and clinical risk management 3, no. 4 

• • QUOTE:
    • Objective:

      To determine if simple adherence measures, such as twenty-four hour recall and refill history, are accurate for routine use, compared to more time-consuming measures such as pill counts.

    • Main outcome measures:

      Adherence was measured by pill counts, twenty-four hour recall by patient, and refill history per computer record. Temporal changes in these adherence measures were assessed using general linear models for repeated measures.

    • Results

      Adherence was consistently greater for the experimental agent than for the statin therapy (n = 148). Mean pill count adherence for statin drug was 78.7 ± 25.2% compared to 93.5 ± 11.6% (P < 0.001) for the study agent. Refill history and twenty-four hour recall inaccurately measured adherence when compared to pill counts. Adherence, as determined by pill count, for both experimental (P = 0.029) and statin therapy (P = 0.015) showed significant variability across time in general linear models. Neither refill history nor twenty-four hour recall was sensitive to temporal changes.

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