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Are Trial Sponsors Treading On Investigators’ Toes In Decentralized Trials?

 
• By Vibha Sharma

The Danish regulator’s experience with reviewing and inspecting decentralized elements in clinical trials highlights concerns around the blurring of lines that divide the roles and responsibilities of sponsors and trial investigators.

Woman discussing with doctor through tablet PC at home
Decentralized Trials Have Grown In Popularity Since The COVID-19 Pandemic • Source: Alamy

A year after the Danish Medicines Agency became one of the first EU regulators to issue national guidance on supporting decentralized trials (DCTs), it has developed good insight into the types of challenges that companies typically face in designing and executing such studies.

A common problem with such trials is the “blurring” of the traditional division of roles between sponsors and trial investigators,...

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Swissmedic Appoints Trivigno As New Agency Head From 2026

 
• By Anabel Costa-Ferreira

Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

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• By Francesca Bruce

Expanded confidential pricing for pharmaceuticals is intended to help manage medicines expenditure, according to Amgros, the procurement agency that will negotiate the prices.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

More from Geography

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By Vibha Sharma

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.