COA Educational Resources and Publications of Interest
The Science of Clinical Outcome Assessment (COA) in Medical Product Development - An Intensive Online Educational Series
This online educational series introduces COA fundamentals to those seeking greater knowledge and skills in the emerging science of COA. Professionals can earn CEUs or take as a non-credit course.
Recommended Publications: Content Validity
- Content Validity – Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 1 – Eliciting Concepts for a New PRO Instrument, Donald L. Patrick, PhD, MSPH1, et al.
- Content Validity – Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report, Part II – Assessing Respondent Understanding, Donald L. Patrick, PhD, MSPH1, et al.
- Use of Existing Patient-Reported Outcome (PRO) Instruments and Their Modification: The ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification Pro Task Force Report, Margaret Rothman, PhD, et al.
Recommended Publications: Translation and Cultural Adaption
- Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation, Diane Wild, MSc, et al.
- Multinational Trials – Recommendations on the Translations Required Approaches to Using the Same language in Different Countries, and the Approaches to Support Pooling the Data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report, Diane Wild, MSc, et al.
Other Recommended Publications
- Incorporating the Patient’s Perspective into Drug Development and Communication: An Ad Hoc Task Force Report of the Patient-Reported Outcomes (PRO) Harmonization Group Meeting at the Food and Drug Administration, February 16, 2001. Catherine Acquadro, MD, et al.
- Patient-Reported Outcomes to Support Medical Product Labeling Claims: FDA Perspective, Donald L. Patrick, PhD, MSPH1, et al.
- Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-Based Patient-Reported Outcome (PRO) Measures: ISPOR ePRO Good Research Practices Task Force Report, Stephen Coons, PhD, et al.
- Pediatric Patient- Reported Outcome Instruments for Research to Support Medical Product Labeling: Report of ISPOR PRO Good Research Practices for the Assessment of Children and Adolescents Task Force, Louis S. Matza, PhD, et al.
- Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report, Katy Benjamin, PhD, SM, et al.
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