Help Industry With Clinical Trial Design

Resources

Clinical Outcome Assessments

Clinical Outcome Assessment (COA) Qualification Program U. S. Food and Drug Administration (FDA) (link)

Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims U. S. Food and Drug Administration (FDA) (link)

Clinical Outcome Assessment Compendium U. S. Food and Drug Administration (FDA) (link)

The Science of Clinical Outcome Assessment (COA) in Medical Product Development - An Intensive Online Educational Series University of Maryland School of Pharmacy (link)

Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry U. S. Food and Drug Administration (FDA) (link)

Tips for Success

Patient's Role in Designing Clinical Trials Global Genes (link)

Effective Engagement with Patient Groups Around Clinical Trials Clinical Trials Transformation Initiative (CTTI) (link)

Guiding Principles for Interaction with Patient Advocacy Organizations Biotechnology Innovation Organization (BIO) (link)

Rare Diseases: Common Issues in Drug Development Guidance for Industry U. S. Food and Drug Administration (FDA) (link)