Diversity & Inclusion

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
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A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
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HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
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The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.


What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
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A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
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The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials, Andrea Manfrin, tells the Pink Sheet what sponsors can expect from the new regulation.


Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
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The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

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

 

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’

 
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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

 
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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

 

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.

US FDA’s Trump Transition Relatively Smooth, Except For Diversity, Equity Work

 

Several critical FDA drug activities can skirt early Trump administration directives, but trial diversity and health equity work may be hobbled.

EU’s €66.8M Project To ‘Transform Clinical Studies’ By Boosting Diversity

 

A six-year project aiming to establish a “less fragmented and more democratic” approach to clinical studies has commenced in the EU.

Science and Politics May Collide As US FDA Offers More Precise Definitions Of Sex And Gender

 

The draft guidance clarifies that sex and gender are not interchangeable, but could be vulnerable in the Trump Administration as Republicans have argued against transgender medical care and that sex and gender must be congruent.


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

 
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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.

UK's Clinical Trials Diversity Draft Gets Over 200 Stakeholder Responses

 
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As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.

Califf: Sponsors Should Go Beyond Letter Of Law With Trial Diversity Plans

 

The FDA Commissioner wants sponsors to incorporate diversity into their development programs prior to Phase III.