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Clinical Trial Diversity Action Plans Required Under US Funding Bill

 
• By Sue Sutter

Omnibus legislation requires FDA to issue guidance documents and hold public workshops on clinical trial diversity, but it does not give the agency authority to mandate postmarketing studies if a preapproval trial falls short of demographic diversity goals.

Diverse hands
Clinical trial diversity efforts will get a boost from the US government funding bill. • Source: Shutterstock

In their pre-Christmas government funding bill, US lawmakers were not in a giving mood when it came to bestowing the Food and Drug Administration with a lot of extra authority to ensure drug sponsors conduct sufficiently diverse clinical trials.

However, they also declined to give industry some safe harbor protections on use of digital health technologies and remuneration to...

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More from Clinical Trials

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.

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.

More from R&D

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.

Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.