The Society for Clinical Data Management (SCDM) conference landed in Orlando last week providing insights and key trends for clinical data managers from around the world. In this blog we share an infographic of some of the agenda highlights along with a more detailed overview of our Alla Muchnik's contribution to the session Study Medication Compliance: Data Collection Challenges.
This infographic summarizes some of the SCDM 17 highlights from the sessions that our team attended. Then, read on below for a dive into Alla Muchnik's session.
Cytel contribution: Study Medication Compliance: Data Collection Challenges.
Alla Muchnik is a Senior Clinical Data Manager at Cytel with a passion for building clinical databases. This session chimed particularly well with her experience acting as data manager on studies where study drug compliance is part of the protocol and has an impact on the outcomes.
The session included 3 short presentations from Megan Olberding, Cecilia Calcagno, and Alla Muchnik followed by an interactive discussion. In her presentation, Muchnik discussed the challenges of CRF design where the site is capturing such data as investigation product assignment and details; dispensation types and details; drug suspension and discontinuation reasons; and drug reconciliation.
Some of the questions considered by the group during the roundtable discussion included:
1. What approaches to Study medication data collection have you used, which modalities ( paper, electronic, smart packaging), what data are collected ( compliance dosing, non compliance dosing, pill count, combination)?
2. How does your experience mirror or differ from the speakers' experience?
3. What do you see as key data elements that require special attention for delivering quality data for study drug accountability?
4. What do you see as the three biggest road blocks to successful study medication data collection?
5. What would you recommend to be three best practices for collection of study medication data?
6. How do you feel these best practices would hold up in an inspection interview?
While opinions and experiences varied across pharma and CRO participants, everyone agreed that study drug compliance is a very challenging part of trial management. Many participants didn’t tend to capture compliance at a pill count level within the Electronic Data Capture system, instead relying on the study outcomes. On the other hand, some were able to share their experiences of devices used in capturing compliance, (for example, a bottle cap that sends a signal when it opens or a pill chip.)
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