Clinical Trial Transparency To Move Up A Notch In UK

HRA To Build Sanctions Into Its Study Approvals Process

The UK Health Research Authority has adopted a new strategy to give more teeth to its statutory objective of driving improvements in research transparency.

Clinical trials
HRA Plans To Measure Transparency Performance Of Individual Sponsors • Source: Shutterstock

The Health Research Authority has unveiled its much-awaited strategy on how it plans to improve clinical trial transparency in the UK with provisions that will introduce “fair consequences for those who don’t take transparency seriously.”

More from United Kingdom

England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.

England’s NICE To ‘Explore’ Severity Modifier Changes As Cost-Effectiveness Threshold Branded ‘Ridiculous’

 

Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.

Branded Pharma And Generics Industries At Odds Over UK VPAG Framework

 

The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning “as intended” and opposes any changes.

More from Europe

European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

 

Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.

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

 
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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.

German Ordinance To Implement HTA Reg Leaves Room For Doubt

 

A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.