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1.
Exploring the Potential of External Control Arms created from Patient Level Data: A case study in non-small cell lung cancer.
J Biopharm Stat
; 32(1): 204-218, 2022 01 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-34986069
2.
Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis.
Lancet Oncol
; 22(11): 1573-1581, 2021 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-34656225
3.
FDA Approval Summary: Olaparib Monotherapy or in Combination with Bevacizumab for the Maintenance Treatment of Patients with Advanced Ovarian Cancer.
Oncologist
; 26(1): e164-e172, 2021 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-33017510
4.
Does Knowledge of Treatment Assignment Affect Patient Report of Symptoms, Function, and Health Status? An Evaluation Using Multiple Myeloma Trials.
Value Health
; 24(6): 822-829, 2021 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-34119080
5.
Demystifying the estimand framework: a case study using patient-reported outcomes in oncology.
Lancet Oncol
; 21(10): e488-e494, 2020 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-33002444
6.
CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis.
Lancet Oncol
; 21(2): 250-260, 2020 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-31859246
7.
Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy.
Curr Oncol Rep
; 22(11): 116, 2020 08 27.
Artículo
en Inglés
| MEDLINE | ID: mdl-32851542
8.
A Bayesian approach in design and analysis of pediatric cancer clinical trials.
Pharm Stat
; 19(6): 814-826, 2020 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-32537913
9.
US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017.
Lancet Oncol
; 20(10): e582-e589, 2019 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-31579004
10.
FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.
Oncologist
; 24(4): 563-569, 2019 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-30541754
11.
Analyzing patient-reported outcome data when completion differs between arms in open-label trials: an application of principal stratification.
Pharmacoepidemiol Drug Saf
; 28(10): 1386-1394, 2019 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-31410963
12.
Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis.
Lancet Oncol
; 19(2): 229-239, 2018 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-29361469
13.
Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.
Value Health
; 21(6): 742-747, 2018 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-29909880
14.
Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials.
Clin Trials
; 15(6): 624-630, 2018 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-30141714
15.
FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti-Angiogenic Therapy and Exploratory Predictive Biomarker Analysis.
Oncologist
; 22(3): 311-317, 2017 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-28232599
16.
FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy.
Oncologist
; 22(7): 873-878, 2017 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-28533473
17.
FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy.
Oncologist
; 22(11): 1347-1353, 2017 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-28904172
18.
Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis.
Lancet
; 384(9938): 164-72, 2014 Jul 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-24529560
19.
U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.
Oncologist
; 20(8): 960-6, 2015 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-26070917
20.
A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma.
Clin Cancer Res
; 2024 Feb 28.
Artículo
en Inglés
| MEDLINE | ID: mdl-38416426