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Sponsored by the Office of Clinical Pharmacology
OTS, CDER, U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) will host a virtual public workshop entitled “Roadmap to 2030 for New Drug Evaluation in Older Adults” on March 23, 2021. This workshop will bring together stakeholders from academia, industry, and regulatory agencies in a virtual setting to discuss the current status of inclusion of older adults in clinical trials and strategies to ensure the safe and effective use of drugs in this population.

Date: Tuesday, March 23, 2021

Time: 10:00 am - 4:30 pm

Location: This is a virtual public workshop.

Background:

Americans are leading longer and healthier lives than ever before, but older adults often consume multiple prescription medications and may be under-represented in pre-marketing drug evaluations, leading to insufficient data on the safety and effectiveness of medications for this population. Initial pharmacokinetic/pharmacodynamic studies and later clinical trials to evaluate age-related changes often do not include typical older adults who have multiple chronic conditions and take multiple medications. This can lead to insufficient data on the safety and effectiveness of medications in this population at the time of marketing approval. Data on the safety and effectiveness for new medications likely to be prescribed in typical older adults, especially those at the oldest end of the age span, are critically needed. This workshop will discuss methods to ensure that inclusion of older adults in drug evaluations is representative of the target population for treatment and will also discuss potential strategies to ensure safe and effective drug use in older adults.  

Workshop Objectives:

• Review the current regulations and draft guidances for drug evaluation and labeling of medications for older adults
• Review the current data on the inclusion of older adults in clinical trials in selected key therapeutic areas
• Identify the gaps in regulations, guidances, and inclusion of older adults in data collection
• Explore approaches to close the existing gaps

Meeting Information and Registration:

This workshop is open to the public with no cost to attend, but registration is required. To register, please visit https://www.eventbrite.com/e/fda-roadmap-to-2030-for-new-drug-evaluation-in-older-adults-tickets-137460709683.

Meeting Information:

• Agenda (PDF - 43 KB)
• Bios (PDF - 649 KB)
• References (PDF - 52 KB)
• Older Adult Workshop, Part 1: https://youtu.be/PYyc_qS5sPc
• Older Adult Workshop, Part 2: https://youtu.be/z4JhTxIYt-4

Meeting Presentations: (to be added)

Session 1

• Slatum, Patricia - The Problem Statements (PDF - 605 KB)
• Lau, S.W. Johnny - History of FDA guidance on drug evaluation in older adult patients (PDF - 1,046 KB)
• Inouye, Sharon - Enrollment of older adults in COVID-19 trials (PDF - 482 KB)
• Cerreta, Francesca - EMA perspective on guidance on medicines for older people (PDF - 318 KB)

Session 2:

• Temple, Robert - The way forward (PDF - 208 KB)
• Madabushi, Rajanikanth - Clinical pharmacology strategies, FDA perspective (PDF - 707 KB)
• Cook, Jack & Haertter, Sebastian Pharmaceutical industry perspective (PDF - 871 KB)
• Burckart, Gilbert - Lessons learned from pediatric drug development for the older adult community (PDF - 200 KB)
• Schwartz, Janice B. - An initial step to improve representativeness of older age groups in drug development (PDF – 1,172 KB)
• Califf, Robert - What should the framework for older adults be and how to achieve that framework- clinical trials perspective (PDF – 1,475 KB)

Contact:

If you have any additional questions about this workshop, please contact [email protected].