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COVID-19 Phase III Trial Design: Big Ambitions, Little Consistency

 
• By Bridget Silverman

As remdesivir’s change in primary endpoint illustrates, there are many ways to measure potential treatments. A Pink Sheet analysis of 50 Phase III clinical trial protocols found numerous different approaches. Adaptive trials seems critical for speed, but a survival endpoint seems essential for durability.

3D Coronavirus cells

The fast growth of the COVID-19 clinical pipeline has resulted in a heterogenous group of pivotal treatment trial designs and clinical endpoints, a Pink Sheet analysis of 50 Phase III clinical trial protocols found.

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More from Clinical Trials

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
• By Vibha Sharma

The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

 
• By Eliza Slawther

Pharmaceutical companies need to “pressure test” their clinical development strategies early for health technology assessment purposes, particularly in light of the new EU HTA Regulation, a life sciences consultant says.

More from R&D

Aragen’s CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

 
• By Vibha Ravi

Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an interview.

‘Come Early, Come Often,’ EMA Chief Tells Industry

 
• By Francesca Bruce

The European Medicines Agency’s chief, Emer Cooke, explained how the agency could help companies with their drug development plans, and said the EU Health Technology Assessment Regulation would help companies design clinical trials that are fit for regulators and HTA bodies.

Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

 
• By Eliza Slawther

Pharmaceutical companies need to “pressure test” their clinical development strategies early for health technology assessment purposes, particularly in light of the new EU HTA Regulation, a life sciences consultant says.