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

Published on: Jul 29, 2021

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

Video

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

Nov 11, 2021

Blog

Celebrating 40 Years of Rare Disease Progress: WODC Highlights

Jun 6, 2023

Report

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

May 22, 2023

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

Webinar

Accelerate global drug development: Leveraging China regulatory changes

Aug 15, 2025

Blog

Population variability: important considerations in vaccine development

Jun 14, 2023

Webinar

Assessing appropriate use of ECAs in clinical trials

May 28, 2023

Webinar

Adaptive strategies for more efficient, data-rich and patient-friendly trials

May 28, 2023

Playbook

Mitigating risk, protecting potential: Practical strategies that position cell and gene therapy development for success

Mar 28, 2023

Whitepaper

The Chinese Pharmaceutical Market: Size, R&D, Regulations, Market Access and Innovations

Mar 9, 2023

Article

Implementing patient-centric decentralized clinical trials in Japan

Mar 16, 2023

Related Insights

Video

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

Nov 11, 2021

Blog

Celebrating 40 Years of Rare Disease Progress: WODC Highlights

Jun 6, 2023

Report

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

May 22, 2023

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

Webinar

Accelerate global drug development: Leveraging China regulatory changes

Aug 15, 2025

Show more