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

Randomized Study Objectives Should Drive Choice Of Real-World Data Sources, Experts Say

Executive Summary

Start with the trial’s primary objective and then figure out which RWD sources could help inform that outcome, experts say at Duke-Margolis meeting; however, design and underlying objectives of Novo Nordisk’s real-world use of trial of Ozempic have the FDA’s Robert Temple suggesting success will be a ‘longshot.’

You may also be interested in...



US FDA's Temple On Real-World Evidence: 'I Find The Whole Thing Very Frustrating'

CDER deputy director for clinical science reiterates his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims.

Efficacy Studies Not Enough? Consider GSK's Salford Lung Study As New Model

Full results from asthma patients included in the Salford Lung Study provide powerful support for the use of “real world” effectiveness studies as a more relevant form of evidence to inform prescribing choices and improve patient outcomes, particularly in what turned out to be a general population of asthmatics that were still suffering symptoms under usual care.

Real-World Evidence: Lessons From GSK's Salford Lung Study

The Salford Lung Study is pioneering in the emerging field of gathering real-world evidence. David Leather, Global Medical Affairs Leader in the Respiratory Franchise at GSK, led the UK-based study and talked to the Pink Sheet about why it was important for GSK and what may come next.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS140510

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