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Repurposing historical control clinical trial data to provide safety context
Prakash Bhuyan1, Jigar Desai2, Matthew St Louis2
1Pfizer Vaccine Research, 500 Arcola Road, Collegeville, PA 19426, USA.
Drug Discovery Today
|November 3, 2015
Summary
Historical clinical trial data, though abundant, is underutilized. Aggregating this data, like in the eControls database, can improve new drug safety evaluations by providing essential context and background incidence rates.
Area of Science:
- Clinical pharmacology and drug development
- Biostatistics and data science in healthcare
- Regulatory science and drug evaluation
Background:
- Vast amounts of historical clinical trial data are archived but remain underutilized.
- Existing data holds potential for enhancing the evaluation of new medicinal products.
- Lack of context and standardized methods hinders the use of historical control data.
Purpose of the Study:
- To address the underutilization of historical clinical trial data.
- To propose a method for aggregating historical data for improved drug evaluation.
- To introduce the eControls database for leveraging control arm data.
Main Methods:
- Development of the eControls database using control arms from licensed product studies.
- Aggregation of historical study-level data.
- Analysis of challenges and solutions for applying historical data in product safety interpretation.
Main Results:
- The eControls database provides a valuable resource for historical safety and incidence rate data.
- Demonstrated the potential of aggregated historical data to offer context for new drug evaluation.
- Identified key challenges in the application of historical data.
Conclusions:
- Historical data, when properly aggregated and applied, can significantly improve the interpretation of new medicinal product safety.
- The eControls database offers a practical solution for utilizing archived control arm data.
- Further development and validation are needed to optimize the use of historical data in regulatory decision-making.
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