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Pink Sheet Podcast: Clinical Trial Diversity, Off-Label Standard Of Care Issues, In-Person US FDA Adcomms

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams’ views on how the FDA can better ensure clinical trial diversity, questions about approving a new drug that would be used with a standard of care regimen that is off-label, and the agency beginning to schedule fully in-person advisory committee meetings.

Pink Sheet podcast
Will advisory committee meetings change upon their return to fully in-person sessions? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss former US Surgeon General Jerome Adams’ view that additional regulation is necessary to ensure industry complies with clinical trial diversity requirements (:27), as well as questions about the US Food and Drug Administration potentially approving Zevra Denmark A/S’ arimoclomol in Niemann-Pick disease type C, but with an unapproved standard-of-care regimen (15:00). They also consider any adjustments sponsors and others may encounter when the FDA returns to fully in-person advisory committee meetings in September (24:03).

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Clinical trial draft guidance webpages are back online following a court order, but with new language disclaiming any information promoting gender ideology as "extremely inaccurate."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

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.

Last Chance For Pharma To Respond To EU Strategy For Reforming Ecosystem For SMEs

 
• By Eliza Slawther

Companies have until 17 March to respond to an EU consultation on a new strategy that will seek to simplify the regulatory framework and make it easier for innovative small and medium-sized enterprises to “access the capital they need” to scale up in the bloc.