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EU Addresses Complex Clinical Trial Designs In New Guideline

 
• By Vibha Sharma

The advent of precision medicine has prompted sponsors to experiment with complex clinical trial designs, which can involve increased operational complexity. A new EU-wide guidance has been issued on the subject to pave the way for a harmonized approach.

Clinical trial
Complex trials are more commonly used in oncology • Source: Shutterstock

An EU group has issued long-awaited guidance on the key aspects that drug companies should consider when initiating and conducting complex clinical trials, which are fast gaining ground as a way to support the development of personalized medicines. The guideline explains the different approaches that sponsors should follow when filing a clinical trial application or requesting substantial amendments for a complex trial as compared to a conventional trial.

The guideline has been issued by the Clinical Trials Facilitation and Coordination Group (CTFG), which functions under the aegis of...

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EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

 
• By Eliza Slawther

There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

More from Geography

EU CHMP Opinions And MAA Updates

 
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Crosstalk On Drug Pricing: Conflicts In Trump Team Rhetoric And Policy

 
• By Michael McCaughan

The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.

Price Inflation Rebates: Biden Policies Add Teeth To Trump’s Pharma Tariff Threat

 
• By Cathy Kelly

Companies with significant exposure to Medicare and Medicaid have fewer options for passing along higher costs to consumers because of price controls in the programs.