An assessment of patient-reported outcomes for men with erectile dysfunction: Pfizer's perspective

Author:

Cappelleri J C,Stecher V J

Publisher

Springer Science and Business Media LLC

Subject

Urology

Reference56 articles.

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2. Acquadro C, Berzon R, Dubois D, Leidy NK, Marquis P, Revicki D et al. 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. Value Health 2003; 6: 522–531.

3. Fairclough DL . Patient reported outcomes as endpoints in medical research. Stat Methods Med Res 2004; 13: 115–138.

4. Wiklund I . Assessment of patient-reported outcomes in clinical trials: the example of health-related quality of life. Fundam Clin Pharmacol 2004; 18: 351–363.

5. U.S. Food and Drug Administration. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (DRAFT). U.S. Department of Health and Human Services, Food and Drug Administration: Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH).February 2006. Available at http://www.fda.gov/cder/guidance/5460dft.htm .[accessed 6 January 2008].

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