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

Cancer Trials: Beware Of ‘Digital Exhaust’ When Planning Clinical Outcome Assessments

Executive Summary

Patient data gathered through wearables and sensors can complement traditional patient-reported outcome assessments, but continuous digital monitoring runs the risk of overburdening clinical trial participants.

You may also be interested in...



Standardization Of Patient-Focused Core Clinical Outcomes Could Enable Labeling Comparisons

US FDA’s Theresa Mullin envisions having a national catalog of standard core clinical outcomes assessment measures that could apply to every disease area.

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in PRO assessment strategies has lessened the regulatory utility of such data from cancer trials, the agency says; new draft guidance recommends systematic assessment of a core set of PROs in registrational studies using fit-for-purpose tools and includes examples of acceptable instruments.

US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios

Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS144737

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