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.
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.
- 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
Workshop Website: https://go.usa.gov/xsnrx