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

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

This article was originally published in SRA

Executive Summary

A new patient-reported outcomes instrument for assessing toxicities in oncology trials ultimately could create an opportunity for comparative tolerability claims across cancer treatments.

You may also be interested in...



Cancer Trials: Patient-Reported Outcomes Should Measure Five Core Concepts, US FDA Says

Heterogeneity in PRO assessment strategies has lessened the regulatory utility of such data from cancer trials, the agency says; new draft guidance recommends systematic assessment of a core set of PROs in registrational studies using fit-for-purpose tools and includes examples of acceptable instruments.

As Aducanumab’s US FDA Review Progressed, Support Grew For Accelerated Approval

Use of expedited pathway for Biogen's Alzheimer's drug was discussed at a center director briefing in late April, where it garnered backing from several senior CDER officials, as well as CBER director Peter Marks and OCE director Richard Pazdur.

Pink Sheet Podcast: Adcoms Too Emotional, Pushing Gene Therapy Science, Congress Gets UFA Update

Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.

UsernamePublicRestriction

Register

PS118535

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