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Real-World Evidence Challenges: Death Among Toughest Data Points To Measure

 
• By Derrick Gingery

Death typically is not included in electronic health records, and sources are disparate; Difficulties with endpoint expose potential limitation to real-world evidence use.

Data Collection - Three Arrows Hit in Red Target

Death, likely among the easiest real-world data points to measure, is proving among the more difficult to gather, illustrating that while real-world data holds great promise, there still are fundamental hurdles to overcome before its widespread use.

Researchers and regulators are hopeful that electronic health records and claims data, so-called real-world data, can be shown to correlate well with clinical trial results and eventually support regulatory decisions

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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

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EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
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