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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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Kiji CEO On EU HTA Regulation, Hospital Exemption And The Future Of ATMPs

 
• By Eliza Slawther

Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

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.

More from R&D

Industry Keen On ‘Stepwise’ PIPs, But Future Hinges On EU Pharma Legislation Reform

 
• By Eliza Slawther

Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.

EMA Initiative To Address Information Overload In CTIS Training Materials

 
• By Vibha Sharma

The European Medicines Agency has launched a phased initiative to consolidate the wide array of training materials for the Clinical Trials Information System, aiming to eliminate duplication, ensure consistency, improve accessibility and enhance user-friendliness.

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.