Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Clinical Trial Diversity Measures Primed For Inclusion In US FDA User Fee Legislation

Executive Summary

House subcommittee hears testimony on merits of various proposals to increase diversity of clinical trial participants; whether lawmakers ultimately favor measures that impose enforceable obligations on sponsors, or merely incentivize more diverse enrollment, remains to be seen.

You may also be interested in...



Clinical Trial Diversity Action Plans Required Under US Funding Bill

Omnibus legislation requires FDA to issue guidance documents and hold public workshops on clinical trial diversity, but it does not give the agency authority to mandate postmarketing studies if a preapproval trial falls short of demographic diversity goals.

Clinical Trial Diversity Would Benefit From Regulatory, Financial Incentives, Experts Say

Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.

Clinical Trial Diversity: User Fee Bill Wants FDA’s Assessment Of Whether It Needs More Authority

HHS is to evaluate the need for FDA authority to mandate postapproval studies or postmarket surveillance if sponsors do not meet diversity enrollment goals. By contrast, the DEPICT Act would have given the agency the authority to do so.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145875

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel