Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices

Area of Science:

• Clinical Research
• Health Outcomes Research
• Regulatory Science

Background:

• Patient-Reported Outcome (PRO) measures are crucial for clinical trials and regulatory submissions.
• The U.S. Food and Drug Administration (FDA) requires rigorous validation for PRO measures used in product labeling.
• The PRO Consortium developed novel PRO measures necessitating a standardized translation process.

Purpose of the Study:

• To describe the rationale and goals of the PRO Consortium's instrument translation process.
• To establish a standardized and rigorous linguistic validation (LV) process for PRO measures.
• To ensure translations meet regulatory and pharmaceutical industry expectations.

Main Methods:

• A consensus process involving 13 translation companies with LV expertise.
• Consolidation of best practices to generate a proposed translation process.
• Iterative feedback from translation companies and PRO Consortium members through two review rounds.

Main Results:

• Development of a 12-step consensus-driven translation process.
• The process includes universal and country-specific translation approaches.
• It addresses both new translations and adaptations of existing ones.

Conclusions:

• The PRO Consortium's translation process ensures the validity of PRO data.
• It standardizes linguistic validation, meeting regulatory and industry standards.
• This process supports consistent and reliable use of PRO measures across studies.