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Clinical Trials: US Diversity Action Plans Could Benefit From EQBMED Pilot Program

 
• By Sue Sutter

The Equitable Breakthroughs in Medicine Development initiative, funded with a PhRMA grant, provides sites in historically under-represented communities with support to conduct clinical research. In an interview, EQBMED’s Tesheia Johnson Harris talks about the local sites selected, therapeutic areas for research, and learnings to date.

Communities of color
EQBMED is identifying community-facing clinical trial sites in historically under-represented communities of color. (Shutterstock)

The Equitable Breakthroughs in Medicine Development (EQBMED) pilot program’s lessons for bringing clinical trials to underserved areas could help inform sponsors’ trial diversity actions, which are expected to be required by the US Food and Drug Administration starting in late 2025.

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Cross-Atlantic Alliance Sets Sights On First HTA Methods Recommendations

 
• By Francesca Bruce

A new collaboration of health technology appraisal bodies in the US, England and Canada could lead to better alignment on HTA methodology in the future.

PICO Exercises: A Glimpse Into Future Joint Clinical Assessments Under EU HTA Regulation

 
• By Eliza Slawther

The European Commission has released three exercises to help pharma companies prepare for joint clinical assessments under the new EU Health Technology Assessment Regulation. Experts explain how manufacturers should interpret these and what their limitations are.

Navigating the Unknown: EU HTA Regulation’s Impact On Commercial Confidentiality

 
• By Eliza Slawther

Company dossiers submitted for EU-level joint clinical assessments under the Health Technology Assessment Regulation will be made public. This could conflict with other strategic business decisions and should be planned for in advance, experts say.

Retiring CDER Deputy Director: Misconception That US FDA Regulators Cannot Change

 
• By Sarah Karlin-Smith

Retiring CDER Deputy Director Douglas Throckmorton spoke to the Pink Sheet ahead of his early 2025 retirement about regulatory flexibility, AI and other topics.

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Industry Urged To Respond To EU Expectations On Using Animal Testing Alternatives

 
• By Eliza Slawther

The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.

Industry Benefits As EU CTIS Hits Global Data Sharing Milestone

 
• By Neena Brizmohun

The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.