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: ‘How Much More Evidence Do We Need To Move Forward?’

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA seeks research ideas and plans to include demographic subgroup analyses in review templates as some stakeholders call for bolder action to change how companies conduct clinical trials.

You may also be interested in...



FDA Carrots And Sticks Are Best Way To Get Subgroup Data, Advocates Say

Stakeholders tell FDA it should force sponsors to recruit more diverse populations for its clinical trials by refusing to approve applications with inadequate data or expediting those with the necessary information.

PhRMA’s “I’m In” Campaign Looks To Connect Minorities To Studies

Extension of the Clinical Trial Engagement Network is aimed at increased diversity in clinical trials, which is becoming increasingly important as more drugs are targeted at specific groups.

Poziotinib Fails To Get FDA Panel Support Though Members Not As Dubious As Agency

Agency’s recent approval of Enhertu, which has better response rate, sways some panel members to vote against Spectrum’s NSCLC drug. FDA’s Pazdur compares poziotinib’s dosing uncertainty to ‘building a house on quicksand.’

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS078197

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