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

When Can You Trust Real-World Evidence? Experts Point Out Pitfalls

Executive Summary

Speedy publication and data validation methods were red flags in studies retracted by Lancet and NEJM, IQIVA’s Nancy Dreyer says. Duke-Margolis and Sanofi researchers note growth in use of real-world evidence in drug applications at DIA’s annual meeting.

You may also be interested in...



Real-World Evidence Likely Untainted By COVID-19 Journal Article Debacle

Retraction of Lancet, NEJM studies does not signal doubts about the utility of RWE for evaluating drug efficacy and safety; instead, it highlights importance of transparency, validation and audit trails for real-world datasets, and lack of familiarity with RWE methods among medical journal peer reviewers, experts say.

Improper Dose In Phase II Trials Can ‘Make Or Break’ Drug Program, FDA’s Stein Says

Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.

Some US FDA Advisory Committee Meetings Likely To Remain Virtual Post-Pandemic

Peter Stein says FDA will set criteria for holding a virtual meeting and will be seeking stakeholder feedback.

Topics

Related Companies

UsernamePublicRestriction

Register

PS144696

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