Fighting against age discrimination in clinical trials

Area of Science:

• Geriatric Medicine
• Clinical Pharmacology
• Regulatory Science

Background:

• Historically, regulatory agencies have promoted older adult inclusion in clinical trials since the late 1980s.
• Bias against including older participants, especially those with multiple comorbidities, remains a significant issue.
• Discrimination in clinical trials hinders effective drug evaluation for the elderly population.

Purpose of the Study:

• To review the participation of older adults in clinical trials.
• To identify barriers and biases hindering the inclusion of elderly individuals in research.
• To foster collaboration between geriatric societies and regulatory agencies to address these challenges.

Main Methods:

• A roundtable discussion was held at the American Geriatrics Society 2008 Annual Meeting.
• Representatives from geriatric societies (European Union Geriatric Medicine Societies, American Geriatrics Society) and regulatory agencies (U.S. Food and Drug Administration, European Medicine Agency) participated.
• Key issues concerning older adult participation in clinical trials were discussed and summarized.

Main Results:

• The discussion highlighted historical efforts and ongoing challenges in including older adults in clinical trials.
• Identification of the causes of delay and bias against older participants with multiple comorbidities was emphasized.
• The need for collaborative solutions involving geriatric societies and regulatory bodies was recognized.

Conclusions:

• Geriatric societies and regulatory agencies must work together to overcome age discrimination in clinical trials.
• New definitions, study designs, and technologies are needed to improve drug evaluation in older people with multiple comorbidities and polypharmacy.
• Collaborative efforts are crucial for ensuring equitable and effective clinical research for the aging population.