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

ODAC Chairman Rebukes Pfizer, Data Monitoring Committee Over Sutent Trial Conduct

Executive Summary

The actions by Pfizer and its independent Data Monitoring Committee in terminating a Sutent clinical trial may have benefitted the study’s placebo subjects, but were a disservice to the larger community of patients with pancreatic neuroendocrine tumors, the chairman of FDA’s Oncologic Drugs Advisory Committee said April 12.

You may also be interested in...



Sutent Pancreatic Tumor Study Shows Regulatory Pitfalls Of Stopping Early

Pfizer’s development of Sutent (sunitinib) for treatment of pancreatic tumors shows the potential pitfalls sponsors face when they decide to terminate clinical trials early due to positive results.

US FDA Drugs Center Launches Clinical Trial Innovation Hub With Demonstration Projects

CDER’s Center for Clinical Trial Innovation (C3TI) will support innovative clinical trial approaches designed to improve the quality and efficiency of drug development and regulatory decision-making. The initiative includes demonstration projects on Bayesian analyses, selective safety data collection and point-of-care trials.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS053311

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