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US FDA’s Pazdur On When And Why US Patients Must Satisfy Trial Diversity Requirements

 
• By Sarah Karlin-Smith

Flexibility on the geographic location of clinical trial participants will depend on the underlying reasons the FDA wants diversity in the study, the agency’s Oncology Center of Excellence Director said.

earth surrounded by lots of arms in different colors reaching toward it.
The FDA's Richard Pazdur offered advice on meeting diversity requirements with global trials during a 16 October meeting. (Shutterstock)

Drug sponsors should consider why a clinical trial requires a diverse patient population when determining whether US Food and Drug Administration diversity requirements must be met with US-based participants, FDA’s Oncology Center of Excellence Director Richard Pazdur said.

More from Diversity & Inclusion

Makary Signals Some Interest In US FDA Staff Cuts, Fighting Patent Thickets

 
• By Sarah Karlin-Smith

The FDA Commissioner nominee also commented on trial diversity, the role of public comment and expedited biosimilar reviews during his Senate confirmation hearing.

US FDA Says Restored Webpages Do Not Reflect ‘Biological Reality’

 
• By Sue Sutter

Clinical trial draft guidance webpages are back online following a court order, but with new language disclaiming any information promoting gender ideology as "extremely inaccurate."

CRO Group Picks Seven US Sites To Reap Big Gains In Trial Diversity

 
• By Vibha Sharma

The Association of Clinical Research Organizations has awarded “seed funding” to seven US-based community clinical trial sites to demonstrate proof-of-concept projects aimed at increasing diversity in clinical trials.

Kennedy Would Issue Trial Diversity Guidance, But Not Necessarily Roll Back All Anti-DEI Actions

 
• By Sarah Karlin-Smith

The US Health and Human Services Secretary nominee’s commitment should be a positive sign for those who want to ensure Americans can access adequate data on drugs in all populations that could use them.

More from R&D

Japan Expands Priority R&D List For Regular Vaccinations

 
• By Lisa Takagi

Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.

German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 
• By Eliza Slawther

Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.

EU Clinical Trials Regulation Failing To Harmonize Requirements, But UK Has ‘Great Opportunity’

 
• By Eliza Slawther

The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.