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Creation and implementation of a historical controls database from randomized clinical trials
Jigar R Desai1, Edward A Bowen, Mark M Danielson
1Worldwide Research and Development BusinessTechnology, Pfizer, Inc., Groton, CT 06340, USA. jigar.desai2@pfizer.com
Summary
Creating a historical placebo controls database from internal clinical trial data is feasible. Such a database can supplement future clinical trials, improving drug development efficiency.
Area of Science:
- Clinical trial methodology
- Data informatics
- Drug development
Background:
- Ethical concerns and participant scarcity in clinical trials necessitate exploring historical controls.
- Previous advocacy for historical control databases lacked technical implementation details.
Purpose of the Study:
- To develop a historical placebo controls database using internal clinical trial data at Pfizer.
- Focus on patients who received placebo in randomized controlled trials.
Main Methods:
- Integrated and standardized disparate internal clinical data.
- Focused on trials in the pain therapeutic area as a pilot study.
- Extracted placebo subject data from eligible completed placebo-controlled studies.
Main Results:
- Identified 2404 completed parallel-design placebo-controlled studies from over 20,000 internal trials.
- Excluded studies before 2000 due to data standards and informed consent issues.
- Extracted placebo data from 1134 eligible studies.
Conclusions:
- Pooling placebo populations is technically feasible for a historical placebo group database.
- A large historical placebo database can supplement, not replace, placebo arms in future trials.
- An industry-wide database with universal standards could enhance clinical trial efficiency.
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