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Sponsors’ Use Of Adaptive Designs Appears To Be Growing

 
• By Cathy Dombrowski

A Drug Information Association working group survey found 477 studies between Jan. 1, 2008 and Sept. 1, 2011 utilized some type of adaptive design.

Pharmaceutical companies are increasingly considering adaptive designs for their clinical trials, particularly in the exploratory phase, the Drug Information Association Adaptive Design Scientific Working Group reports.

The DIA working group defines an adaptive design as “a clinical study design that uses accumulating data to decide whether and how to modify aspects of the study as it...

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UK And US Regulators In Sync On RWD External Control Arms

 
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The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
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Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

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ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

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ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
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The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
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Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.