Pesquisa | Biblioteca Virtual em Saúde

1.

U.S. Food and Drug Administration Reasoning in Approval Decisions When Efficacy Evidence Is Borderline, 2013-2018.

Janiaud, Perrine; Irony, Telba; Russek-Cohen, Estelle; Goodman, Steven N.

Ann Intern Med ; 174(11): 1603-1611, 2021 11.

Artigo em Inglês | MEDLINE | ID: mdl-34543584

2.

Comparing clotting factors attributes across different methods of preference elicitation in haemophilia patients.

Tegenge, Million A; Belov, Artur; Moncur, Megan; Forshee, Richard; Irony, Telba.

Haemophilia ; 26(5): 817-825, 2020 Sep.

Artigo em Inglês | MEDLINE | ID: mdl-32842165

3.

Incorporation of stochastic engineering models as prior information in Bayesian medical device trials.

Haddad, Tarek; Himes, Adam; Thompson, Laura; Irony, Telba; Nair, Rajesh.

J Biopharm Stat ; 27(6): 1089-1103, 2017.

Artigo em Inglês | MEDLINE | ID: mdl-28281931

4.

Incorporating patient-preference evidence into regulatory decision making.

Ho, Martin P; Gonzalez, Juan Marcos; Lerner, Herbert P; Neuland, Carolyn Y; Whang, Joyce M; McMurry-Heath, Michelle; Hauber, A Brett; Irony, Telba.

Surg Endosc ; 29(10): 2984-93, 2015 Oct.

Artigo em Inglês | MEDLINE | ID: mdl-25552232

5.

Case-Control Studies-Reply.

Irony, Telba Z.

JAMA ; 321(8): 807, 2019 02 26.

Artigo em Inglês | MEDLINE | ID: mdl-30806687

6.

Case-Control Studies: Using "Real-world" Evidence to Assess Association.

Irony, Telba Z.

JAMA ; 320(10): 1027-1028, 2018 Sep 11.

Artigo em Inglês | MEDLINE | ID: mdl-30422270

7.

Bayesian Statistics for Medical Devices: Progress Since 2010.

Campbell, Gregory; Irony, Telba; Pennello, Gene; Thompson, Laura.

Ther Innov Regul Sci ; 57(3): 453-463, 2023 05.

Artigo em Inglês | MEDLINE | ID: mdl-36869194

8.

Application of Bayesian approaches in drug development: starting a virtuous cycle.

Ruberg, Stephen J; Beckers, Francois; Hemmings, Rob; Honig, Peter; Irony, Telba; LaVange, Lisa; Lieberman, Grazyna; Mayne, James; Moscicki, Richard.

Nat Rev Drug Discov ; 22(3): 235-250, 2023 03.

Artigo em Inglês | MEDLINE | ID: mdl-36792750

9.

Adaptation of the WOMAC for Use in a Patient Preference Study.

Stothers Rosenberg, Sarah; Ng, Xinyi; Mansfield, Carol; Poulos, Christine; Peay, Holly; Lee, Ting-Hsuan; Irony, Telba; Ho, Martin.

Ther Innov Regul Sci ; 57(4): 702-711, 2023 07.

Artigo em Inglês | MEDLINE | ID: mdl-37061632

10.

Preferences for potential benefits and risks for gene therapy in the treatment of sickle cell disease.

Gonzalez Sepulveda, Juan Marcos; Yang, Jui-Chen; Reed, Shelby D; Lee, Ting-Hsuan; Ng, Xinyi; Stothers, Sarah; Irony, Telba; Ho, Martin; Rothman, Jennifer A; Badawy, Sherif; Rowley, Carolyn; Little, Jane; Shah, Nirmish R; Li, Kaiwen; Telen, Marilyn J.

Blood Adv ; 7(23): 7371-7381, 2023 12 12.

Artigo em Inglês | MEDLINE | ID: mdl-37905989

11.

The "Utility" in Composite Outcome Measures: Measuring What Is Important to Patients.

Irony, Telba Z.

JAMA ; 318(18): 1820-1821, 2017 Nov 14.

Artigo em Inglês | MEDLINE | ID: mdl-29136430

12.

Preferences for Risks and Benefits of Islet Cell Transplantation for Persons With Type 1 Diabetes With History of Episodes of Severe Hypoglycemia: A Discrete-Choice Experiment to Inform Regulatory Decisions.

Wilson, Leslie; Kwok, Tiffany; Ma, Yanlei; Wong, Jenise; Ho, Martin; Ionova, Yelena; McGrath, Maureen; Mueller, Monica M; Gitelman, Stephen E; Irony, Telba.

Transplantation ; 106(8): e368-e379, 2022 08 01.

Artigo em Inglês | MEDLINE | ID: mdl-35655355

13.

Bayesian approaches in medical device clinical trials: a discussion with examples in the regulatory setting.

Bonangelino, Pablo; Irony, Telba; Liang, Shengde; Li, Xuefeng; Mukhi, Vandana; Ruan, Shiling; Xu, Yunling; Yang, Xiting; Wang, Chenguang.

J Biopharm Stat ; 21(5): 938-53, 2011 Sep.

Artigo em Inglês | MEDLINE | ID: mdl-21830924

14.

Patient-centered clinical trials.

Chaudhuri, Shomesh E; Ho, Martin P; Irony, Telba; Sheldon, Murray; Lo, Andrew W.

Drug Discov Today ; 23(2): 395-401, 2018 02.

Artigo em Inglês | MEDLINE | ID: mdl-28987287

15.

Advancing the science of patient input throughout the regulatory decision-making process.

Tegenge, Million A; Moncur, Megan M; Sokolic, Robert; Forshee, Richard A; Irony, Telba.

Learn Health Syst ; 1(3): e10032, 2017 Jul.

Artigo em Inglês | MEDLINE | ID: mdl-31245564

16.

Joint Estimation of Treatment and Placebo Effects in Clinical Trials with Longitudinal Blinding Assessments.

Liu, Wei; Zhang, Zhiwei; Schroeder, R Jason; Ho, Martin; Zhang, Bo; Long, Cynthia; Zhang, Hui; Irony, Telba Z.

J Am Stat Assoc ; 111(514): 538-548, 2016.

Artigo em Inglês | MEDLINE | ID: mdl-27110045

17.

Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism.

Morales, Jose Pablo; Li, Xuefeng; Irony, Telba Z; Ibrahim, Nicole G; Moynahan, Megan; Cavanaugh, Kenneth J.

J Vasc Surg Venous Lymphat Disord ; 1(4): 376-84, 2013 Oct.

Artigo em Inglês | MEDLINE | ID: mdl-26992759

18.

Erratum to: Inaugural Conference on Incorporating Patient-Reported Outcomes and Patient Preference Information into Clinical Research, Clinical Care, and Risk-Benefit Assessments for Neurodegenerative Diseases.

Purks, Jennifer L; Wilhelm, Erin E; Shoulson, Ira; Creveling, John; Dorsey, E Ray; Irony, Telba; LoCastro, Tara M; Pagan, Fernando; Ravina, Bernard; Simuni, Tanya; Sterling, MaryAnne; Tariot, Pierre; Anderson, Karen E.

Patient ; 10(5): 667-668, 2017 10.

Artigo em Inglês | MEDLINE | ID: mdl-28766071

19.

Inaugural Conference on Incorporating Patient-Reported Outcomes and Patient Preference Information into Clinical Research, Clinical Care, and Risk-Benefit Assessments for Neurodegenerative Diseases.

Purks, Jennifer L; Wilhelm, Erin E; Shoulson, Ira; Creveling, John; Dorsey, E Ray; Irony, Telba; LoCastro, Tara M; Pagan, Fernando; Ravina, Bernard; Simuni, Tanya; Sterling, MaryAnne; Tariot, Pierre; Anderson, Karen E.

Patient ; 10(5): 541-544, 2017 10.

Artigo em Inglês | MEDLINE | ID: mdl-28688021

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U.S. Food and Drug Administration Reasoning in Approval Decisions When Efficacy Evidence Is Borderline, 2013-2018.

Comparing clotting factors attributes across different methods of preference elicitation in haemophilia patients.

Incorporation of stochastic engineering models as prior information in Bayesian medical device trials.

Incorporating patient-preference evidence into regulatory decision making.

Case-Control Studies-Reply.

Case-Control Studies: Using "Real-world" Evidence to Assess Association.

Bayesian Statistics for Medical Devices: Progress Since 2010.

Application of Bayesian approaches in drug development: starting a virtuous cycle.

Adaptation of the WOMAC for Use in a Patient Preference Study.

Preferences for potential benefits and risks for gene therapy in the treatment of sickle cell disease.

The "Utility" in Composite Outcome Measures: Measuring What Is Important to Patients.

Preferences for Risks and Benefits of Islet Cell Transplantation for Persons With Type 1 Diabetes With History of Episodes of Severe Hypoglycemia: A Discrete-Choice Experiment to Inform Regulatory Decisions.

Bayesian approaches in medical device clinical trials: a discussion with examples in the regulatory setting.

Patient-centered clinical trials.

Advancing the science of patient input throughout the regulatory decision-making process.

Joint Estimation of Treatment and Placebo Effects in Clinical Trials with Longitudinal Blinding Assessments.

Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism.

Erratum to: Inaugural Conference on Incorporating Patient-Reported Outcomes and Patient Preference Information into Clinical Research, Clinical Care, and Risk-Benefit Assessments for Neurodegenerative Diseases.

Inaugural Conference on Incorporating Patient-Reported Outcomes and Patient Preference Information into Clinical Research, Clinical Care, and Risk-Benefit Assessments for Neurodegenerative Diseases.