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Clinical Research Coordinator Analysis

Rescue Medication Adherence and Reporting

Finding: The protocol's guidelines for rescue medication (Section 5.2.1), particularly the nuanced conditions for initiating different potencies of topical corticosteroids (TCS) based on body area, symptom severity ("worsening" vs. "intolerable"), and treatment duration (after 2 weeks on study drug, with a 14-day limit for medium/high potency TCS), combined with the daily diary requirement to meticulously record type, location, and duration of application (Section 5.4.5), poses a significant challenge for participant understanding and consistent, accurate reporting. This complexity increases the risk of inadvertent protocol deviations in rescue medication use and compromises the integrity of concomitant medication data. Recommendation: To mitigate these risks, we recommend the development and provision of highly simplified, participant-friendly educational aids. These could include a laminated quick-reference card or a visual guide illustrating permitted rescue medications, application areas, and usage restrictions. CRCs should allocate dedicated time during initial and subsequent visits for thorough training on these rules and precise diary completion, using teach-back methods to confirm understanding. Furthermore, the subject diary design should incorporate highly structured fields for rescue medication entries to prompt for all required details systematically. Rationale: This proactive approach will enhance participant comprehension and compliance with the complex rescue medication regimen, leading to more accurate data collection on concomitant therapies, reducing protocol deviations, minimizing data queries, and ultimately strengthening the reliability of the study's efficacy and safety assessments.