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COVID-19: Global Agencies Step Up Focus On Real-World Data

International Clinical Cohorts Proposed To Share Expertise

 
• By Ian Schofield

There is much talk around the importance of clinical trials in finding new treatments and vaccines for COVID-19 patients, but observational studies in clinical practice also have a vital role to play, including the impact on pregnant women. 

Coronavirus
Regulatory agencies around the world are stepping up their coronavirus cooperation • Source: Shutterstock

International regulators have agreed to increase their cooperation in three areas where observational studies of real-world data could be useful in the fight against the coronavirus pandemic, including research on the impact on pregnant women of the coronavirus itself and any treatments taken, as well as vaccine safety and efficacy monitoring.

“High-quality observational research is an important complement to the evidence on the safety and effectiveness of vaccines and treatments for...

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More from Europe

Project Orbis: Annual UK Approvals Down Since 2022, But MHRA Touts Advantages

 
• By Eliza Slawther

The UK MHRA has emphasized the merits of the Project Orbis scheme, which has resulted in 12 new drug approvals and 14 indication extensions in the country so far. However, overall annual approval figures were lower in 2023 and 2024 than in the years prior.

US Policy Shift Sparks German Contingency Plans For Accessing ClinicalTrials.gov, PubMed

IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.

UK Must Pay ‘A Little Bit More, A Little Bit Earlier’ For Gene Therapies – CGT Catapult Chief

 
• By Eliza Slawther

If the UK is to become a top three country in the cell and gene therapy space, it must overcome the current political “stumbling block” around making changes that recognize the value of these therapies, Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, tells the Pink Sheet.

Results Reporting: UK Registry To Offer More Flexibility Than US-Based ClinicalTrials.gov

 
• By Vibha Sharma

ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.

More from Geography

Indegene Exec On DTP Distribution As A ‘Tactical Solution’, Feasibility Of MFN Model

 
• By Anju Ghangurde

Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US, including potentially introducing new intermediaries into the system. Questions on MFN's feasibility and why it may be “catastrophic” to biopharma were also part of the discussion

Best Laid Plans: A Chronology Of Post-Pandemic COVID-19 Vaccines

 
• By Bridget Silverman

Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.

Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions

 
• By Sarah Karlin-Smith

The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.