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FDA Panel Looks Beyond Xarelto’s Missing Data Problems To Broader Reforms

 
• By Sue Sutter

Despite the agency’s decision to limit discussion about missing data to the ATLAS pivotal trial of rivaroxaban, Cardio-Renal advisory committee members suggested reforms that sponsors should consider to prevent the kinds of problems seen in ATLAS.

FDA advisory committee members weighing use of Johnson & Johnson/Bayer HealthCare AG’s Xarelto (rivaroxaban) for acute coronary syndromes took the opportunity to look beyond the sNDA, and the problems resulting from missing data in the ATLAS pivotal study, to consider how best to prevent clinical study participants and their outcomes from going missing in the first place.

Reforms suggested by Cardiovascular and Renal Drugs Advisory Committee members included bolstering consent procedures so that participants can make better...

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New UK Network Targets Speed And Inclusion For Commercial Clinical Trials

 
• By Vibha Sharma

The UK government expects that its new nation-wide network will enable companies to set up clinical trials more quickly and expand access to diverse patient populations across the National Health Service.

Oncology: Plan Ahead To Rule Out Harm When Survival Not The Endpoint, US FDA Says

 
• By Michael McCaughan

The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.

Selective Safety Data Collection In Clinical Trials: Adoption Lags Despite Benefits, US FDA Says

 
• By Manas Mishra

Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.

US Policy Shift Sparks German Contingency Plans For Accessing ClinicalTrials.gov, PubMed

 
• By Francesca Bruce

IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.

More from R&D

US Policy Shift Sparks German Contingency Plans For Accessing ClinicalTrials.gov, PubMed

 
• By Francesca Bruce

IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.

Results Reporting: UK Registry To Offer More Flexibility Than US-Based ClinicalTrials.gov

 
• By Vibha Sharma

ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.

UK Tests Risk-Proportionate Review Of Substantial Clinical Trial Amendments

 
• By Vibha Sharma

Sponsors running clinical trials in the UK can get a decision on their applications to make substantial but low-risk amendments to their studies within 14 days under a pilot that is testing a streamlined pathway ahead of new clinical trial regulations coming into force in April 2026.