Drugs

Workshop on Including Older Adults in Trials

FDA has announced a 3/23 virtual public workshop entitled “Roadmap to 2030 for New Drug Evaluation in Older Adults” to discuss the current status of including older adults in clinical trials and strategies to ensure safe and effective drug use in the elderly. FDA says it is concerned about older adults, who often take multiple prescription medications, and their under-representation in pre-marketing drug evaluations.

“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,” FDA says. “This can lead to insufficient data on the safety and effectiveness of medications in this population at the time of marketing approval.”

The workshop is designed to:

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

To register, visit https://www.eventbrite.com/e/fda-roadmap-to-2030-for-new-drug-evaluation-in-older-adults-tickets-137460709683

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