EP 5 - Navigating the MRCT Center’s Long-Term Follow-Up Toolkit for Gene Therapies скачать в хорошем качестве

EP 5 - Navigating the MRCT Center’s Long-Term Follow-Up Toolkit for Gene Therapies

In this fifth episode of the MRCT Center podcast, Dr. Barbara Bierer, Faculty Director of the MRCT Center and professor of medicine at BWH and HMS, discusses the newly released Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up (LTFU) Studies for Gene Therapies with Carolyn Chapman, Leader of the Cell and Gene therapies project at the MRCT Center, Lead Investigator at BWH and member of the faculty at HMS. ⏰ TIMESTAMPS: 00:00 - Intro (Dr. Barbara Bierer) 01:15 - Understanding Long-term Follow-up Studies 02:50 - The Intended Users 03:46 - Designing the Toolkit Through Collaboration 05:40 - It’s a Timely Toolkit Because... 07:23 - Content and Structure of the Toolkit 11:05 - Goldilocks!? 13:03 - Minimizing the Burden 15:53 - Withdrawal and Patient Rights 18:01 - Return of Results 20:40 - Addressing Company Disbandment/Program Discontinuation 23:04 - Patient/Participant Resources 23:57 - Implementation of the Toolkit for ’Real’ Impact 25:42 - In Closing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Learn More: Access the full LTFU Toolkit and additional standalone resources at: https://mrctcenter.org/LTFUToolkit Subscribe & Share: LinkedIn**  / multi-regional-clinical-trials-center-of-b...   Our Website**https://mrctcenter.org/