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Real-World Data: US FDA Gets 2 Out Of 10 In Abernethy’s Self-Assessment Of COVID Usage

 
• By Sue Sutter

But principal deputy commissioner gives FDA an ‘8 or 9 on vision’ of how to use RWD to address the pandemic and other challenges. The low ‘execution’ score is due to the large amount of effort needed to understand what datasets are available, how they can be used with confidence and what questions they can answer, Abernethy says.

Stylized measuring ruler watercolour illustration. One single object, front view, green color, cute design, 10 centimetres long. Hand painted colorful sketchy drawing, isolated clip art element.
Amy Abernethy was asked to rate the role of real-world data in combatting COVID on a scale of 1-10. • Source: Shutterstock

The COVID-19 pandemic has highlighted the importance of having real-world datasets that are fit for purpose and that regulators know how to use, Amy Abernethy, principal deputy commissioner of the US Food and Drug Administration, said on 2 September.

In a prerecorded fireside chat and live question-and-answer session at the Healthcare Analytics Summit, Abernethy said the COVID crisis has spurred a greater appreciation for the potential utility of real-world data, not only in combating the pandemic now but

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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

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Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

 
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Pharmaceutical companies need to “pressure test” their clinical development strategies early for health technology assessment purposes, particularly in light of the new EU HTA Regulation, a life sciences consultant says.

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
• By Neena Brizmohun

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 
• By Eliza Slawther

Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.

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UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
• By Vibha Sharma

The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

 
• By Eliza Slawther

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