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Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates
Beth Harper1, Zachary Smith2, Jane Snowdon3
1Clinical Performance Partners, Aurora, IL, USA.
Therapeutic Innovation & Regulatory Science
|May 8, 2021
Summary
Mid-study database updates in clinical trials are disruptive and time-intensive. Managing these challenges is crucial for improving efficiency as data volume and complexity grow.
Area of Science:
- Clinical data management
- Drug development operations
Background:
- Evaluated causes, degree, and disruptive nature of mid-study database updates.
- Assessed clinical data management's response to increasing data volume and diversity.
Purpose of the Study:
- To understand the impact of mid-study database updates.
- To identify challenges in managing clinical trial data.
Main Methods:
- Conducted a global online survey (September-October 2020) in collaboration with IBM Watson Health.
- Analyzed 194 verified responses from clinical trial professionals.
Main Results:
- Mid-study database updates (planned and unplanned) are the primary challenges.
- An average of 4.1 planned and 3.7 unplanned updates occurred per trial.
- Management of these updates was found to be time-intensive.
Conclusions:
- Mid-study database updates significantly disrupt clinical trial processes.
- Addressing these disruptions offers a key opportunity to enhance efficiency and accelerate cycle times.
- Increasing protocol flexibility and data diversity necessitate improved data management strategies.
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