Clinical endpoint

Results: 228



#Item
131Clinical trials / Epidemiology / Medical research / Medical terms / Chemical pathology / Biomarker / Surrogate endpoint / Imaging biomarker / Medicine / Biology / Health

Biomarkers, Surrogates & Qualification MRD in Acute Lymphoblastic Leukemia Workshop White Oak, April 2011 Marc K Walton MD, PhD

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Source URL: www.fda.gov

Language: English
132Health / Pharmacology / Clinical research / Drug safety / Pharmacy / New Drug Application / Pharmaceutical industry / FDA Fast Track Development Program / Surrogate endpoint / Food and Drug Administration / Pharmaceutical sciences / Medicine

RESTRICTED I MARKETING UNDER ACCELERATED

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Source URL: www.fda.gov

Language: English - Date: 2000-06-26 03:45:46
133Research / Clinical research / Epidemiology / Interventional radiology / Angioplasty / Clinical trials / Clinical endpoint / Surrogate endpoint / Medicine / Health / Medical statistics

The Detrimental Impact of Chronic Renal Insufficiency

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Source URL: www.pmda.go.jp

Language: English - Date: 2012-06-18 00:45:41
134Laboratory techniques / Biomarkers / Biotechnology / Chemical pathology / Assay / Clinical endpoint / Multiplex / Medicine / Biology / Chemistry

Study Checklist for CTEP-Supported Early Phase Trials with BIOMARKER ASSAYS INSTRUCTIONS: For INTEGRAL assay, respond to Items 1-7. For INTEGRATED assay, respond to Items 1-3 and[removed]In lieu of completing items 5-6

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Source URL: ctep.cancer.gov

Language: English - Date: 2014-04-15 10:11:05
135Phenols / Clinical research / Cystic fibrosis / Pediatrics / Ivacaftor / Vertex Pharmaceuticals / Placebo / Statin / Health / Medicine / Biology

June 24, 2014 Two 24-Week Phase 3 Studies of Lumacaftor in Combination with Ivacaftor Met Primary Endpoint with Statistically Significant Improvements in Lung Function (FEV1) in People with Cystic Fibrosis who have Two

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Source URL: files.shareholder.com

Language: English
136

Supplemental analyses Additional analyses were done to assess the robustness of the results in the Clinical Success endpoint. Those analyses assessed the poolability of the data across treatment sites and any bias result

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Source URL: www.fda.gov

Language: English
    137Medical statistics / Research / Clinical trials / Clinical research / Medical terms / Surrogate endpoint / Biomarker / Heart failure / Medicine / Health / Epidemiology

    CVCT Forum 2012 HEART FAILURE TRIALISTS WORKSHOP Learning from Recent Trials and Shaping the Future of Heart Failure Japanese Regulatory Viewpoint

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    Source URL: www.pmda.go.jp

    Language: English - Date: 2013-02-17 21:53:36
    138Health / Nursing research / Pharmaceutical industry / Clinical Data Management / National Institutes of Health / National Institute of Allergy and Infectious Diseases / Clinical trial / Good Clinical Practice / Clinical Data Interchange Standards Consortium / Research / Clinical research / Medicine

    Expanded distribution of clinical research endpoint data

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    Source URL: www.niaid.nih.gov

    Language: English - Date: 2013-04-26 13:28:48
    139Clinical research / Research / Scientific method / Epidemiology / Evaluation methods / Clinical trial / Clinical study design / Clinical endpoint / Design of experiments / Science / Medical statistics

    MPCC SEMINAR SERIES April 6, 2010 An Overview of the FDA Draft Guidance on Adaptive Design Clinical Trials Henry S. Hsu, Ph.D., M.P.H.

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    Source URL: www.fda.gov

    Language: English
    140Clinical research / Epidemiology / Medical statistics / Food and Drug Administration / United States Public Health Service / Clinical trial / Clinical endpoint / Research / Pharmaceutical sciences / Pharmacology

    FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) Meeting FDA White Oak Campus, Building 31, The Great Room (Rm. 1503)

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    Source URL: www.fda.gov

    Language: English
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