Surrogate endpoint

Results: 164



#Item
121Clinical trials / Research / Medical statistics / Medical research / Medical terms / Surrogate endpoint / Clinical endpoint / Biomarker / Randomized controlled trial / Medicine / Epidemiology / Health

Surrogate Endpoints Mark Rothmann* Minimal Residue Disease in CLL Workshop February 27, 2013 *The views expressed in this presentation are those of the presenters and do not necessarily represent those of the U.S. Food a

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Source URL: www.fda.gov

Language: English
122Research / Viral load / Surrogate endpoint / HIV / FDA Fast Track Development Program / Clinical endpoint / Food and Drug Administration / Imaging biomarker / Discovery and development of integrase inhibitors / Medicine / HIV/AIDS / Health

Predicting/Providing Substantial Evidence of Clinical Benefit for New Drug Approvals Albert Deisseroth, Division of Hematology Products February 27, 2013

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Source URL: www.fda.gov

Language: English
123Doctoral degrees / Doctor of Medicine / Higher education / Minimal residual disease / Education / Academia / Knowledge

Minimal Residual Disease (MRD) as a Surrogate Endpoint in Chronic Lymphocytic Leukemia (CLL) Workshop R. Angelo de Claro, M.D., William Wierda, M.D., Ph.D., and Gregory Reaman, M.D., Co-Chairs

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Source URL: www.fda.gov

Language: English
124Clinical trials / Epidemiology / Medical research / Medical terms / FDA Fast Track Development Program / Surrogate endpoint / Minimal residual disease / B-cell chronic lymphocytic leukemia / Center for Devices and Radiological Health / Medicine / Health / Food and Drug Administration

Transcript: Public Workshop on Minimal Residual Disease (MRD) as a Surrogate Endpoint in Chronic Lymphocytic Leukemia (CLL)

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Source URL: www.fda.gov

Language: English
125Health / Clinical trials / Clinical research / Medical research / Medical terms / Surrogate endpoint / Clinical endpoint / Biomarker / Randomized controlled trial / Medicine / Biology / Epidemiology

Statistical Considerations for Surrogate Endpoints Mark Rothmann* Minimal Residue Disease in AML Workshop March 4, 2013 *The views expressed in this presentation are those of the presenters and

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Source URL: www.fda.gov

Language: English
126Epidemiology / Medical research / Medical terms / Pharmacology / Surrogate endpoint / Biomarker / Food and Drug Administration / Acute myeloid leukemia / Minimal residual disease / Medicine / Health / Clinical trials

[removed]Federal Register / Vol. 77, No[removed]Wednesday, December 26, [removed]Notices The Food and Drug Administration (FDA) is correcting a

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Source URL: www.gpo.gov

Language: English - Date: 2012-12-22 11:14:57
127Epidemiology / Medical research / Pharmacology / Clinical trials / Medical terms / Surrogate endpoint / Biomarker / Minimal residual disease / Imaging biomarker / Medicine / Health / Research

Companion Diagnostic Guidance

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Source URL: www.fda.gov

Language: English
128Epidemiology / Medical research / Pharmacology / Clinical trials / Medical terms / Surrogate endpoint / Biomarker / Minimal residual disease / Imaging biomarker / Medicine / Health / Research

Companion Diagnostic Guidance

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Source URL: www.fda.gov

Language: English
129Research / Viral load / Surrogate endpoint / HIV / FDA Fast Track Development Program / Clinical endpoint / Food and Drug Administration / Imaging biomarker / Discovery and development of integrase inhibitors / Medicine / HIV/AIDS / Health

Predicting/Providing Substantial Evidence of Clinical Benefit for New Drug Approvals Albert Deisseroth, Division of Hematology Products March 4, 2013

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Source URL: www.fda.gov

Language: English
130

Minimal Residual Disease (MRD) as a Surrogate Endpoint in Chronic Lymphocytic Leukemia (CLL) Workshop DISCUSSION POINTS

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Source URL: www.fda.gov

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