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Early Access to Medicines Scheme: real-world data collection.
Hok Pang1, Meng Wang1, Christopher Kiff1
1Bristol-Myers Squibb Pharmaceuticals Ltd., London, UK.
Drug Discovery Today
|June 23, 2019
Summary
Real-world data (RWD) collected before drug approval can supplement clinical trial results. A robust data collection framework is essential to ensure the validity and applicability of this valuable RWD.
Area of Science:
- Pharmaceutical research
- Data science in healthcare
Background:
- Clinical trials are the cornerstone of drug approval.
- Real-world data (RWD) offers complementary insights into treatment outcomes.
- Current RWD collection methods may lack standardization for pre-approval use.
Purpose of the Study:
- To highlight the potential of pre-approval RWD.
- To emphasize the necessity of a structured data collection framework.
- To discuss ensuring the validity and applicability of RWD.
Main Methods:
- Literature review and conceptual framework development.
- Analysis of existing data collection practices.
- Discussion of best practices for RWD integration.
Main Results:
- Pre-approval RWD can provide valuable supplementary evidence.
- A standardized framework is crucial for RWD reliability.
- Methodological rigor is key for RWD applicability.
Conclusions:
- Implementing a data collection framework is vital for leveraging pre-approval RWD.
- Standardized RWD enhances its value in regulatory decision-making.
- Future research should focus on developing and validating such frameworks.
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