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1.
Estimation of treatment effects in short-term depression studies. An evaluation based on the ICH E9(R1) estimands framework.
Pharm Stat
; 21(5): 1037-1057, 2022 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-35678545
2.
EMA Review of Axicabtagene Ciloleucel (Yescarta) for the Treatment of Diffuse Large B-Cell Lymphoma.
Oncologist
; 25(10): 894-902, 2020 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-32339368
3.
Beyond "Intent-to-treat" and "Per protocol": Improving assessment of treatment effects in clinical trials through the specification of an estimand.
Br J Clin Pharmacol
; 86(7): 1235-1239, 2020 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-31883123
4.
The changing landscape of data monitoring committees-Perspectives from regulators, members, and sponsors.
Biom J
; 61(5): 1232-1241, 2019 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-30589102
5.
The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.
Br J Clin Pharmacol
; 84(5): 1013-1019, 2018 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-29370449
6.
How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.
Br J Clin Pharmacol
; 82(4): 965-73, 2016 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-27245362
7.
Protocol adherence and the progression of cardiovascular calcification in the ADVANCE study.
Nephrol Dial Transplant
; 28(1): 146-52, 2013 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-23028103
8.
Presence of valvular calcification predicts the response to cinacalcet: data from the ADVANCE study.
J Heart Valve Dis
; 22(3): 391-9, 2013 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-24151766
9.
Ultrasonographic measures of synovitis in an early phase clinical trial: a double-blind, randomised, placebo and comparator controlled phase IIa trial of GW274150 (a selective inducible nitric oxide synthase inhibitor) in rheumatoid arthritis.
Clin Exp Rheumatol
; 30(2): 254-61, 2012.
Artículo
en Inglés
| MEDLINE | ID: mdl-22409880
10.
The Impact of COVID-19 on the Initiation of Clinical Trials in Europe and the United States.
Clin Pharmacol Ther
; 111(5): 1093-1102, 2022 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-35090044
11.
Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey.
JMIR Med Inform
; 10(1): e30363, 2022 Jan 27.
Artículo
en Inglés
| MEDLINE | ID: mdl-35084343
12.
Access to patient-level trial data--a boon to drug developers.
N Engl J Med
; 369(17): 1577-9, 2013 Oct 24.
Artículo
en Inglés
| MEDLINE | ID: mdl-24144395
13.
Effectiveness of cinacalcet in patients with recurrent/persistent secondary hyperparathyroidism following parathyroidectomy: results of the ECHO study.
Nephrol Dial Transplant
; 26(6): 1956-61, 2011 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-20947534
14.
The inhaled phosphodiesterase 4 inhibitor GSK256066 reduces allergen challenge responses in asthma.
Respir Res
; 11: 26, 2010 Mar 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-20193079
15.
Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials.
Clin Pharmacol Ther
; 107(5): 1059-1067, 2020 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-32017052
16.
Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation.
Clin Pharmacol Ther
; 107(4): 773-779, 2020 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-31574163
17.
Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency.
Trials
; 19(1): 642, 2018 Nov 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-30454061
18.
Does access to clinical study reports from the European Medicines Agency reduce reporting biases? A systematic review and meta-analysis of randomized controlled trials on the effect of erythropoiesis-stimulating agents in cancer patients.
PLoS One
; 12(12): e0189309, 2017.
Artículo
en Inglés
| MEDLINE | ID: mdl-29228059
19.
Control of mild to moderate asthma over 1-year with the combination of salmeterol and fluticasone propionate.
Respir Med
; 100(1): 2-10, 2006 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-16243498
20.
Rethinking the intention-to-treat principle: one size does not fit all.
J Clin Epidemiol
; 125: 198-200, 2020 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-32380178