SECTION TITLEANALYTICAL


data standards and frameworks to ensure data quality. Optimizing PRO qualification is a nexus objective for patient-focused drug development, involving and benefiting patients, drug sponsors, and regulators. The continued coordinated efforts of each of these stakeholders will be needed to expand the catalogue of qualified PROs and other drug development tools.


Conclusion


Biopharmaceutical development is entering a new era of patient-centered drug develop- ment. The formerly disparate efforts of regulators, individual companies, and patient groups are coalescing around common goals and objectives. Patient empowerment, technological advances, astute regulatory policy, and remarkable drug development successes have provided some of the inspiration for this progress. Going forward, continuing to ensure that the patient voice is prominent both in the industry development activities and in regulatory benefit-risk decisions will remain key to the ongoing success of the innovative biopharmaceutical industry.


References


1. US Food and Drug Administration. The Voice of the Patient: A Series of Reports from FDA's Patient-Focused Drug Development Initiative. Available at: http://www. fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ ucm368342.htm. Accessed January 12, 2015.


2. US Food And Drug Administration. Prescription Drug User Fee Act (PDUFA). Available at: http://www.fda. gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ UCM2005475.htm. Accessed January 12, 2015.


3. US Food And Drug Administration. Enhancing Benefit- Risk Assessment in Regulatory Decision-Making. Available at: http://www.fda.gov/ForIndustry/UserFees/ PrescriptionDrugUserFee/ucm326192.htm. Accessed January 11, 2015.


4. US Food and Drug Administration. Clinical Outcome Assessment (COA): Glossary of Terms. Available at: http:// www.fda.gov/Drugs/DevelopmentApprovalProcess/ DrugDevelopmentToolsQualificationProgram/ ucm370262.htm#pro. Accessed January 11, 2015.


5. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD. Reporting of Patient Reported Outcomes in Randomized Clinical Trials: The CONSORT PRO Extension. JAMA. 2013;309(8):814-833.


6. Scoggins JF, Patrick DL. The Use of Patient Reported Outcome Instruments In Registered Clinical Trials; Evidence From ClinTrials.gov. Contemp Clin Trials. 2009;30(4): 289-292.


7. US Food and Drug Administration. Drug Development Tools (DDT) Qualification Programs. Available at: http:// www.fda.gov/Drugs/DevelopmentApprovalProcess/ DrugDevelopmentToolsQualificationProgram/. Accessed January 12, 2015.


8. Critical Path Institute. Patient-Reported Outcome Consortium. Available at: http://c-path.org/programs/ pro/. Accessed January 12, 2015.


9. US Food and Drug Administration. Clinical Outcome Assessment Qualification Program. Available at: http:// www.fda.gov/Drugs/DevelopmentApprovalProcess/ DrugDevelopmentToolsQualificationProgram/ ucm284077.htm. Accessed January 12, 2015.


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10. US Food and Drug Administration. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. December 2009. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ UCM193282.pdf. Accessed January 12, 2015.


J. Michael Maher, MS, MBA, is currently Executive Director, U.S. Regulatory Policy at Pfizer, Inc. In this role he works with internal and external partners to


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