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US FDA ‘Project Post COVIDity’ Will Track Infection Impact On Cancer Patients Using Real-World Data

 
• By Grace Moser

Oncology Center of Excellence program will use the Evidence Accelerator to examine COVID’s impact on treatment initiation, regimen selection and therapeutic utilization, potential adverse sequalae, and outcomes.

shutterstock 52899094 Walking crab
Tracking the impact of COVID infections on cancer patients using real-world data is among the new projects launched by the US FDA’s Oncology Center of Excellence. • Source: Shutterstock

The US Food & Drug Administration’s COVID-19 Evidence Accelerator is evaluating the effects of COVID-19 infection on cancer patients via a new Oncology Center of Excellence initiative dubbed “Project Post COVIDity.”

The initial focus will be on understanding how COVID infection impacts cancer patients “on active treatment and associated immunotherapy,” the Oncology Center of Excellence describes in its 2020 annual

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UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.

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

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

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

 
• By Eliza Slawther

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.

More from Clinical Trials

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.