Healthy Skepticism Library item: 11858

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Rock EP, Scott JA, Kennedy DL, Sridhara R, Pazdur R, Burke LB.
Challenges to use of health-related quality of life for food and drug administration approval of anticancer products.
J Natl Cancer Inst Monogr 2007 Oct; (37):27-30
http://jncimono.oxfordjournals.org/cgi/content/abstract/2007/37/27

Abstract:

The U.S. Food and Drug Administration (FDA) approves labeling claims of drug efficacy based on substantial evidence of clinical benefit demonstrated in adequate and well-controlled investigations. Patient-reported outcomes (PROs) may support marketing claims of clinical benefit, either alone or with other study endpoints. Health-related quality of life (HRQL) is a PRO that comprehensively measures patients’ reported health status. We present an overview of why HRQL-based efficacy claims have not to date been accepted by the FDA for inclusion in anticancer product labels. Persistent challenges to allowance of such claims include shortcomings in randomization and blinding of clinical trials, missing data, statistical multiplicity, and unclear intrinsic meaning of selected HRQL findings.

laurie.burke@fda.hhs.gov

Keywords:
PMID: 17951228 [PubMed - in process]