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

Real-World Data Could Get Boost From Trial Replication Project

Executive Summary

Effort to replicate clinical trial results with real-world data could eventually allow for increased use in drug development.

You may also be interested in...



FDA’s Real-World Evidence Project Finds That Pragmatic Clinical Trials Are Easier To DUPLICATE

Results from the US Food and Drug Administration’s RCT DUPLICATE demonstration are in. The findings both legitimize certain real-world evidence studies and also highlight the challenges involved in using RWE to replicate randomized clinical trials.

Tocilizumab COVID-19 Study Shows Bias Against Observational Studies, Harvard Prof Says

Study showing Roche’s Actemra decreased mortality in COVID-19 patients in ICUs by almost 10% was initially rejected by journal editors and then ignored by guideline writers and regulators. FDA officials and industry reps discuss what needs to be done to advance use of real-world evidence from observational studies.

RWE: Comparators, Therapeutic Area May Be Key For Trial Replication

It may be easier to use observational study data to replicate randomized controlled trial results in certain therapeutic areas or where drugs were studied against each other instead of placebo, the US FDA’s David Martin says; the agency-funded DUPLICATE real-world evidence demonstration project has completed replication work on the first five trials, all of which are diabetes drug cardiovascular outcomes studies.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS122984

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