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Getting Real on Quality of Life

 
• By Michael McCaughan

Cancer drug trials seldom answer the real-life questions most important to patients. FDA’s top oncology drug regulator thinks the answer is to do prospective QoL trials

"We have failed as a community" to evaluate quality of life measures, the Food & Drug Administration's top cancer drug regulator told an Institute of Medicine forum in October.

"Many of the attempts to address this issue have been rather haphazardly added to existing clinical trials looking at survival,...

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More from Clinical Trials

Do Policy, Clinical Data, Ocaliva Exit Lend Zydus Helping Hands?

 
• By Vibha Ravi

Intercept’s Ocaliva withdrawal in the US places the spotlight on emerging PBC candidates like Zydus’s saroglitazar, a PPAR agonist that beat both Gilead’s Livdelzi and Ipsen’s Iqirvo on biochemical response in topline results. Will the withdrawal and policy developments boost Zydus’s prospects?

Blueprint For RWE: Aetion Execs Outline Real-World Data Role From Preclinical To Postmarketing

 
• By Bridget Silverman

Sponsors should systematically incorporate real-world evidence generation in all development programs, advises an epidemiology-forward “blueprint” Aetion executives developed.

Clawbacks And Clinical Trial Set Up Are Among UK’s Investment Deterrents

 
• By Francesca Bruce

In the wake of MSD’s decision not to invest $1.35bn in the UK, the Association of the British Pharmaceutical Industry has set out the county’s comparative strengths and weaknesses.

High Clicks, Low Enrollment For Decentralized Arm: Lessons From Europe’s RADIAL Trial

 
• By Vibha Sharma

Despite strong online visibility, Europe's RADIAL trial struggled to convert digital interest from potential study participants into real-world recruitment in its fully decentralized arm.

More from R&D

High Clicks, Low Enrollment For Decentralized Arm: Lessons From Europe’s RADIAL Trial

 
• By Vibha Sharma

Despite strong online visibility, Europe's RADIAL trial struggled to convert digital interest from potential study participants into real-world recruitment in its fully decentralized arm.

Korea’s New Health Minister: ‘Golden Time For The Country To Become A Biopharma Leader’

 
• By Jung Won Shin

Multiple Korean ministries, biopharma companies, and other officials convened at a bio innovation roundtable to discuss strategies to emerge as a global biopharma powerhouse.

Denmark Tackles GCP Inspection Pain Point: Lack Of Direct Access To Patient Records

 
• By Vibha Sharma

Despite being a longstanding requirement under EU and international regulations, the Danish Medicines Agency says its good clinical practice inspectors frequently encounter cases where sponsor-appointed clinical trial monitors are denied direct access to patient records.