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

Project Pragmatica: US FDA’s OCE Initiative Aims To Encourage Simple Clinical Trials

Executive Summary

OCE Director Richard Pazdur says idea for the latest initiative stemmed from a clinical trial in lung cancer that he thought only needed to measure the impact on overall survival.

You may also be interested in...



US FDA’s Project Site Selector Kicks Off With A Look At Why Cancer Trials Go Overseas

Speed, logistics and global regulatory demands are all reasons why sponsors increasingly look outside the US to enroll cancer trials, industry reps say during the inaugural event for the Oncology Center of Excellence's new initiative; OCE director Pazdur says multiregional trials can help provide patients access to important new drugs quickly in the US or worldwide.

Cancer And Accelerated Approval: FDA To Crack Down On Single-Arm Trials, Refractory Disease Focus

US FDA cancer chief Rick Pazdur plans to send industry to ‘rehab’ with Project Frontrunner, which will push for development of cancer drugs in randomized controlled trials in earlier disease. Goal is to reduce time of uncertainty between accelerated approval and confirmatory evidence.

US FDA Calls For Clinical Trial Diversity Plan ‘As Soon As Practicable’ In Product Development

Draft guidance outlines Race and Diversity Plan that would reify some of FDA’s efforts to increase racial and ethnic diversity in clinical trials with a mechanism that is applicable from IND through approval.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS147348

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