Detalhe da pesquisa
1.
Critical Comments by Food and Drug Administration Reviewers on Patient-Reported Outcomes in Food and Drug Administration Regulatory Submissions (2018-2021).
Value Health
; 2024 Mar 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-38458563
2.
Assessment of Patient-Reported Outcomes in Industry-Sponsored Phase I Oncology Studies: Considerations for Translating Theory Into Practice.
Value Health
; 26(10): 1440-1443, 2023 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-37353056
3.
A Review of Labeling Based on Patient-Reported Outcome Endpoints for New Oncology Drugs Approved by the European Medicines Agency (2017-2021).
Value Health
; 26(6): 893-901, 2023 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-36746305
4.
A Review of Patient-Reported Outcome Labeling of FDA-Approved New Drugs (2016-2020): Counts, Categories, and Comprehensibility.
Value Health
; 25(4): 647-655, 2022 04.
Artigo
em Inglês
| MEDLINE | ID: mdl-35365309
5.
Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.
JAMA
; 327(19): 1910-1919, 2022 05 17.
Artigo
em Inglês
| MEDLINE | ID: mdl-35579638
6.
Use of Patient and Investigator Global Impression Scales: A Review of Food and Drug Administration-Approved Labeling, 2009 to 2019.
Value Health
; 24(7): 1016-1023, 2021 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-34243825
7.
Quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: The TOURMALINE-MM3 trial.
Eur J Haematol
; 104(5): 443-458, 2020 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-31880006
8.
A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016).
Value Health
; 22(2): 203-209, 2019 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-30711065
9.
A Review of Patient-Reported Outcome Labeling in the United States (2011-2015).
Value Health
; 20(3): 420-429, 2017 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-28292487
10.
Secukinumab sustains early patient-reported outcome benefits through 1 year: Results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept.
J Am Acad Dermatol
; 76(4): 655-661, 2017 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-28087133
11.
Development of the sporadic inclusion body myositis physical functioning assessment.
Muscle Nerve
; 54(4): 653-7, 2016 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-26872556
12.
Psychometric validation of a patient-reported measure of physical functioning in sporadic inclusion body myositis.
Muscle Nerve
; 54(4): 658-65, 2016 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-26872636
13.
Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds.
Health Qual Life Outcomes
; 12: 31, 2014 Mar 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-24597620
14.
Recommendations to address respondent burden associated with patient-reported outcome assessment.
Nat Med
; 30(3): 650-659, 2024 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-38424214
15.
Assessment of PRO label claims granted by the FDA as compared to the EMA (2006-2010).
Value Health
; 16(8): 1150-5, 2013 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-24326168
16.
Potential of patient-reported outcomes as nonprimary endpoints in clinical trials.
Health Qual Life Outcomes
; 11: 83, 2013 May 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-23675876
17.
A Review of Patient-Reported Outcome Considerations in Oncologic Drugs Advisory Committee Meetings (2016-2021).
JCO Oncol Pract
; 19(5): e745-e762, 2023 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-36854073
18.
Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet-Biedl syndrome: phase 3 trial results.
Orphanet J Rare Dis
; 18(1): 12, 2023 01 16.
Artigo
em Inglês
| MEDLINE | ID: mdl-36647077
19.
A review of patient-reported outcome labels in the United States: 2006 to 2010.
Value Health
; 15(3): 437-42, 2012 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-22583453
20.
Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and biologic license applications, 2006-2010.
Value Health
; 15(3): 443-8, 2012 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-22583454