Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Woodcock Warns Research Apparatus Could Be Overwhelmed If Coronavirus Trials Don’t Use Master Protocols

Executive Summary

CDER Director Janet Woodcock says researchers need to embrace pragmatic trial designs and compare multiple treatments at the same time rather than employ separate development programs.

You may also be interested in...



Better Late Than Never? US FDA’s Oddly Timed COVID Master Protocol Guidance

COVID has unequivocally shown the advantages of a ‘master protocol’ approach to providing definitive evidence about the benefits (or lack thereof) for repurposed therapies to treat a novel infection. Unfortunately, in the US, the proof has been in the failure of scores of separate studies to generate useful evidence. Can FDA change that before the next pandemic?

US FDA’s COVID Master Protocol Guidance To Maintain Influence Post-Pandemic

Agency seeking comment on document intended to replace the just-issued guidance on COVID-19 treatment development as FDA stresses the value of master protocols for developing clinical knowledge.

Pfizer COVID Vaccine Trial Proved Remote Monitoring, Other Innovations Work, ICON CEO Says

Steve Cutler, head of the CRO that conducted Pfizer’s study, tells the Pink Sheet that starting clinical trials in weeks, as opposed to months, should be possible post-pandemic.

Related Content

Topics

UsernamePublicRestriction

Register

PS142080

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