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

Welcome To The Estimand: Patient-Reported Outcome Framework Gets Warm Response At FDA/ASCO Workshop

Executive Summary

Estimand structure is part of effort to generate standard principles and analyses for patient experience data in oncology and beyond.

You may also be interested in...



US FDA Guidance On Endpoints Incorporating Clinical Outcome Assessments Fulfills Patient-Focused Commitment

Stakeholders can weigh in during 4 May 2023 webinar as US FDA rounds out a PDUFA VI commitment with a draft of the fourth of four methodological guidances on patient-focused drug development.

Neurology At The Forefront Of US FDA Complex Innovative Trial Design Pilot

Wave’s Duchenne muscular dystrophy drug crashed, but Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.

Patient-Focused Drug Development: US FDA’s Guidance Development Effort Passes The Mid-Point

Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS140536

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