Interagency Collaboration for Patient-Centered Antibacterial Drug Development

Area of Science:

• Infectious Diseases
• Clinical Trials
• Pharmacoeconomics

Background:

• Antibacterial drug development requires robust clinical trial endpoints.
• Existing endpoints may not fully capture patient experience or functional status.
• The Antibacterial Resistance Leadership Group (ARLG) Innovations Task Force addresses this gap.

Purpose of the Study:

• To present key advances in improving endpoints for antibacterial drug registrational trials.
• To incorporate patient-reported outcomes, including health-related quality of life.
• To ensure trial endpoints reflect patient well-being, function, and survival.

Main Methods:

• Multidisciplinary collaboration including regulatory bodies (FDA), research institutions (NIH), industry, and patient representatives.
• Focus on common acute infections.
• Development and validation of novel endpoints.

Main Results:

• Key advances in defining and implementing patient-centered endpoints have been achieved.
• Incorporation of health-related quality of life measures is progressing.
• Established a framework for meaningful endpoint selection.

Conclusions:

• The ARLG Innovations Task Force is enhancing the relevance and patient-centricity of antibacterial drug trial endpoints.
• Improved endpoints will lead to more meaningful assessments of drug efficacy and impact on patients.
• This work supports the development of better treatments for common infections.