Three ways to work with the FDA for better patient-focused trials

Putting patients at the center of drug development allows us to design more efficient clinical trials that yield better data about a product’s risks and benefits. Companies that collaborate with the FDA can get direct feedback on their methodology and help build consensus on patient-relevant outcomes that might be accepted as proof of efficacy and safety.

This article covers three useful practices for getting the most out of your collaboration.


Open PDF

Return to Insights Center

Related Insights

Report

New Medicines, Novel Insights: Advancing rare disease drug development

May 22, 2023

Blog

Breaking through complex regulations and science speak – thinking “patients first” in lay language summary development

Jun 22, 2021

Blog

Celebrating 40 Years of Rare Disease Progress: WODC Highlights

Jun 6, 2023

Video

Part 2: Risk-based Quality Management Video (RBQM) Series

Nov 11, 2021

Report

New Medicines, Novel Insights: Accelerating development of cell and gene therapies

May 22, 2023

Article

Six top tips to prepare for the new EU Clinical Trial Regulation

Apr 13, 2021

Blog

U.S. drug price reform of 2022: What does the Inflation Reduction Act mean for drug manufacturers?

Aug 17, 2022

Podcast

RBQM Podcast Series | Episode 3: Staying within the Guardrails: How to Push the Boundaries in a Highly Regulated Industry

Jun 16, 2022

Blog

Parexel names first Patient Ambassador

Jun 17, 2022

Article

8 things you need to know about eCTDs in China

Jul 1, 2022

Video

Ensuring Diversity & Inclusion for Clinical Trials

Jul 8, 2022

Blog

Preparing for the New Era of Hybrid Regulatory Inspections

Jul 11, 2022