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

Compliance Concerns Slow Industry Uptake Of Cancer Patient-Reported Outcomes Tool

Executive Summary

Potential need to reconcile physician-reported adverse event data with patient reports of symptom side effects is a concern for Merck; AstraZeneca’s experience using the PRO-CTCAE instrument in cancer trials shows the importance of educating study sites about the value of patient experience data.

You may also be interested in...



Build Patient-Reported Outcomes Into Cancer Drug Dose Optimization, US FDA Says

In exploratory FDA analyses, PRO data appeared more sensitive at detecting an exposure-toxicity relationship for an oral small molecule cancer drug than clinician-reported data; Project Optimus representative dispels industry concerns that FDA wants firms to find the 'mythical' optimal dose.

Patient-Reported Outcomes In Pediatric Cancer Trials Endorsed By US FDA Advisory Committee

Incorporation of the Ped-PRO-CTCAE instrument would help inform short-term tolerability and long-term effects of treatment, particularly newer immunotherapy agents, but there are logistical and operational challenges to overcome, advisory committee members said.

Patient-Reported Outcomes For Organ Transplant Drugs Could Learn From Other Fields

US FDA staff suggest that oncology and rheumatology instruments could be leveraged or supplemented to make them fit for purpose in assessing toxicity of immunosuppressive regimens in transplant recipients.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS120511

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