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Real-World Evidence Uptake Is “Silver Lining” Of COVID-19 Response, USFDA’s Abernethy Says

 
• By Kate Rawson

The coronavirus pandemic highlights the work that is still needed on real-world evidence, agency's principal deputy commissioner says.

Real world data
Sponsors, regulators and patients have criteria that must be met for RWE technology to advance after the pandemic, Abernethy said. • Source: Shutterstock

Drug development during COVID-19 has forced the US Food and Drug Administration and sponsors to accelerate their understanding and adoption of real-world evidence, given the challenges in conducting clinical trials under social distancing guidelines, FDA principal deputy commissioner Amy Abernethy said during a Friends of Cancer Research meeting 22 September.

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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.

Canada’s New Rare Disease Registry Guidance To Assist Regulatory And HTA Decision Making

 
• By Francesca Bruce

Canada’s new guidance on rare disease registries is based on international guidelines, but in some areas there remains work to ensure that implementation of some recommendations is feasible in the Canadian context.

Ad/Promo: Improved Adherence Claim For Dexcel’s Hemady Not Supported, US FDA Says

 
• By Sue Sutter

A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.

More from Clinical Trials

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.

E6(R3) Introduces Flexibility And Challenges To Clinical Trial Documentation

 
• By Vibha Sharma

The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.

EMA’s Newly Qualified AI Tool To Boost MASH Market Dynamics

 
• By Neena Brizmohun

The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.