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Clinical Research Coordinator Analysis

Factor Concentrate Usage Data Collection

Finding: The requirement for participants to record detailed factor concentrate usage (type, dose, lot number, date/time of administration, reason for use) in a daily electronic bleeding log/diary for all breakthrough bleeds, while essential for efficacy endpoints (Section 7.2.1), poses a significant data accuracy and completeness challenge. Participants treating at home may struggle with consistently capturing all details, especially lot numbers from product packaging that may be discarded, leading to potential missing data or recall bias, and subsequently increasing site burden for data reconciliation and queries. Recommendation: To enhance the quality and completeness of factor concentrate usage data, we propose the following site-level operational strategies:

1. Supplement the electronic diary with a physical "Factor Usage Wallet Card" or small, pre-printed paper logs. These can be provided to participants to quickly jot down essential details like lot numbers and doses immediately post-administration, especially if access to the e-diary is not immediate. Vial labels could potentially be affixed to these cards/logs.

2. Intensify training during the Screening visit on the critical importance of capturing all specified details for each factor administration, particularly lot numbers. Provide practical tips, such as encouraging participants to take a photograph of the factor vial/box with their smartphone or to retain all used factor packaging until their next site visit for verification.

3. Develop a standardized site checklist for CRCs to utilize during each visit when reviewing factor usage. This checklist should prompt specific questions about any treatments since the last visit, aiding participant recall and ensuring all protocol-required data fields for factor usage are comprehensively addressed for CRF entry.

4. If feasible, communicate with the Sponsor/e-diary vendor about the possibility of incorporating features like barcode scanning for lot numbers (if factor products commonly have scannable barcodes containing this information) or a simple photo upload capability for vial labels directly into the e-diary application.

Rationale: Implementing these strategies will proactively improve the accuracy and completeness of critical efficacy endpoint data related to factor concentrate usage. It aims to reduce participant reporting burden through simplified capture methods and reinforced training, while also streamlining site data verification processes, ultimately minimizing data queries and enhancing overall data integrity.