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
UsernamePublicRestriction

Patient-Reported Outcomes in Oncology: The Jakafi and Zytiga Exceptions

This article was originally published in RPM Report

Executive Summary

Oncology is the biggest area of biopharmaceutical R&D where patient-reported outcomes are not routinely collected during clinical trials. There are some good reasons why. Jakafi and Zytiga remain outliers oncology treatment with a PRO in the approved label.

You may also be interested in...



Oncology PROs: Limited Use Due To Small Trials, Fast Drug Development

Patient-reported outcomes in oncology clinical trials remain an infrequently used tool, despite acknowledgement by sponsors that the patient experience is important to measure – and encouragement from FDA officials to do so. The lack of PROs in oncology may be a byproduct of the fast pace of cancer drugs are developed in the U.S.: small trials and accelerated pathways.

Oncology Patient-Reported Outcomes Tool May Lead To Comparative Tolerability Claims

New trial designs would be needed to support labeling claim using National Cancer Institute's PRO-CTCAE instrument.

PRO-ving Ground: FDA Review Teams Commit to Patient-Reported Outcomes

FDA recently announced a significant step in furthering the development of patient-reported outcomes: the planned creation of a web-based compendium of clinical outcomes assessments, including PROs. But an even more significant sign that FDA is committed to developing new patient-reported endpoints came directly from reviewers – including some divisions that have not historically been out front on the issue.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS079766

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