Help Industry With Clinical Trial Design

Overview

Your patient group can draw from your patient registries, natural history databases, patient preference studies, and clinical site networks to help industry partners (Sponsors) design clinical trials in terms of subject and site selection, patient-reported outcome and other clinical outcome measures, and study procedures that will be well tolerated by the patients and capture meaningful data. When you and your patient group are involved in clinical trial design, you may improve recruitment, retention, endpoint selection, and study completion.

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)