Establishing optimal requirements for content validity: A work in progress

Value in Health

Volumn 12, Issue 8, 2009, Pages 1074-

  Fehnel, Sheri ^a  

^a RTI HEALTH SOLUTIONS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; CONSUMER ADVOCACY; CONTENT VALIDITY; DRUG APPROVAL; DRUG LABELING; EDITORIAL; FOOD AND DRUG ADMINISTRATION; PRACTICE GUIDELINE; PRIORITY JOURNAL;

EID: 70350769131     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1111/j.1524-4733.2009.00654.x     Document Type: Editorial

References (4)

1. FDA. Food and Drug Administration draft guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. Federal Register, 2006.
2. Mordin M, Clark M, Siersma C, et al. Impact of the FDA Draft Guidance on Patient Reported Outcomes (PRO) label claims for approved drug products in the US: has it made a difference? Poster presented at the International Society for Pharmacoeconomics and Outcomes Research 14th Annual International Meeting, Orlando, FL. May 2009.
3. Nunnally JC, Bernstein I. Psychometric Theory (2nd ed.). New York : McGraw-Hill Book Company, 1978.
4. Williams V, Demuro-Mercon C, Reeve B, Erder E. Implementing FDA PRO guidelines - content validity and good measurement practices: what is the right balance? Issue Panel conducted at the International Society for Pharmacoeconomics and Outcomes Research 14th Annual International Meeting, Orlando, FL. May 2009.