Medtech Insight 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

FDA Guidance Directs Researchers On Use Of Patient Advocates

Executive Summary

A new guidance document from the US agency offers advice on how sponsors can use patient advocates to improve and streamline device clinical trials.

You may also be interested in...



Want Better Clinical Trial Design? Get Early Patient Input, Says FDA

A new guidance document from the US regulatory agency reasons that getting early feedback from patient advocates in the trial-design process could improve enrollment, trial completion and data quality.

Medtech Companies Need To Do Better At Patient Engagement, Expert Says

A top clinical research expert says the medical device industry is lagging behind the pharmaceutical industry when it comes to engaging patients. While industry groups are pushing for more patient preference be factored in in regulatory decisions, John Lewis of patient advocacy group Heart Valve Voice says medtech companies themselves are not investing enough in this area.

Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation

Patients and patient advocacy groups at the US FDA's inaugural Patient Engagement Advisory Committee meeting said they need sponsors to minimize the burdens and augment the comforts of trial participation, and get reports on outcomes along the way. Meanwhile, industry groups worried about revealing too much confidential business information, and biasing trial outcomes.

Topics

Latest News
UsernamePublicRestriction

Register

MT125672

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