A review of patient-reported outcome labels in the United States: 2006 to 2010

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Ari GnanasakthyCatherine Copley-Merriman

Abstract

In 2004, Willke and colleagues reviewed the efficacy endpoints reported in the labels of new drugs approved in the United States from 1997 through 2002 to evaluate the use of patient-reported outcome (PRO) endpoints. Of the labels reviewed, 30% included PROs. Our study aimed to build on this work by describing the current state of PRO label claims granted for new molecular entities (and biologic license applications since February 2006 after the release of the US Food and Drug Administration (FDA) draft PRO guidance. All new molecular entities and biologic license applications approved by the FDA from January 2006 through December 2010 were identified by using the Web page of the FDA Drug Approval Reports. For all identified products, drug approval packages and approved product labels were reviewed to identify PRO endpoint status and to determine the number and type of PRO claims. Of the 116 products identified, 28 (24%) were granted PRO claims; 24 (86%) were for symptoms, and, of these, 9 (38%) claims were pain related. Of the 28 products with PRO claims, a PRO was a primary endpoint for 20 (71%), all symptom related. The FDA continues to approve PRO claims, with 24% of new molecular entities and biologic license applications ...Continue Reading

References

Nov 10, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Kathleen GondekJ Michael Woolley
Nov 13, 2007·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Jeff A SloanUNKNOWN Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group
Jun 27, 2008·Clinical Pharmacology and Therapeutics·L B BurkeA M Trentacosti
Jun 23, 2010·BMJ : British Medical Journal·Jane Speight, Shalleen M Barendse

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Citations

Jul 5, 2013·The New England Journal of Medicine·Ethan Basch
Jan 30, 2014·BMJ : British Medical Journal·Paul WicksJames Heywood
May 17, 2013·Health and Quality of Life Outcomes·Ari GnanasakthyCarla DeMuro
Jul 18, 2014·Journal of General Internal Medicine·Ethan Basch, Antonia V Bennett
Nov 26, 2015·Expert Review of Pharmacoeconomics & Outcomes Research·Alan ShieldsDenise Globe
Aug 28, 2013·Expert Review of Pharmacoeconomics & Outcomes Research·Sheri FehnelAri Gnanasakthy
Feb 19, 2016·Nature Reviews. Cardiology·Daniel B Mark
Jan 18, 2015·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Jennifer PetrilloCheryl D Coon
Oct 31, 2014·Annals of Oncology : Official Journal of the European Society for Medical Oncology·O BylickiJ Péron
Feb 14, 2014·Health and Quality of Life Outcomes·Mary C GawlickiBarbara A Brandt
Dec 3, 2014·Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver·Zobair Younossi, Linda Henry
Jun 28, 2014·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Tara SymondsLucy Abraham
Aug 8, 2015·Journal of Neurosurgery·Ranjith Babu, John H Sampson
May 3, 2015·Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology·Rícheal Ní RíordáinMichael T Brennan
Jun 21, 2015·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Ethan BaschChristine Goertz
Jun 26, 2013·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Pennifer Erickson, Richard J Willke
Jun 26, 2013·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Louis S MatzaMonika Bullinger
Jun 26, 2013·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Stephen Joel Coons
Feb 19, 2013·Contemporary Clinical Trials·Ari GnanasakthyCaroline Boulton
Jan 23, 2013·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Jeffrey M LacknerCharles Baum
Apr 2, 2013·Clinical Therapeutics·Cheryl D Coon, Lori D McLeod
Dec 12, 2013·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Carla DeMuroAri Gnanasakthy
May 7, 2016·Journal of Menopausal Medicine·Jae Hong SangSoo Ah Kim
May 14, 2016·International Orthopaedics·Lizz van der HeijdenMichiel Adrianus Josephus van de Sande
Sep 12, 2016·JACC. Heart Failure·Eldrin F Lewis
Oct 7, 2016·Expert Review of Pharmacoeconomics & Outcomes Research·Linda Henry, Zobair Younossi
Jan 27, 2017·Journal of Managed Care & Specialty Pharmacy·Andrew P BroganSusan L Hogue
Apr 14, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Ari GnanasakthyVijayveer Bonthapally
Mar 3, 2017·Nature Reviews. Disease Primers·Michael P MannsZobair Younossi
Jan 1, 2017·Journal of Patient-reported Outcomes·Louise HumphreyHelen Kitchen
Jun 22, 2017·Health Expectations : an International Journal of Public Participation in Health Care and Health Policy·Na LiuYanbo Zhang
Dec 24, 2017·Health and Quality of Life Outcomes·Murtuza BharmalMichael Schlichting
Mar 25, 2017·Circulation·Daniel E FormanUNKNOWN American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality
Sep 22, 2018·Current Opinion in Supportive and Palliative Care·Laura CannellaJohannes Giesinger
May 23, 2018·Journal of Market Access & Health Policy·Szymon JarosławskiMondher Toumi
Aug 3, 2018·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Zobair M Younossi
Nov 2, 2014·The European Respiratory Journal·Enrico M Clini, Laura Fregonese
Nov 1, 2012·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Arthur Y KimBarbara H McGovern
Dec 15, 2012·Circulation·Alan S GoUNKNOWN American Heart Association Statistics Committee and Stroke Statistics Subcommittee
Mar 18, 2019·International Journal of Epidemiology·Silvia KotonWayne D Rosamond

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