'Clinical trial design' diaporamas de présentation

WHY BAYES? INNOVATIONS IN CLINICAL TRIAL DESIGN & ANALYSIS

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The Regulation of Drug and Biological Products Introduction to the Principles and Practice of Clinical Research

The Regulation of Drug and Biological Products Introduction to the Principles and Practice of Clinical Research. Kathryn C. Zoon, Ph.D Deputy Director Planning and Development DIR/NIAID January 11, 2005. Food and Drug Administration. Office of the Commissioner

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Critical Path Initiative: What it means for pharmaceutical industry statisticians

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Conducting Cost-Effectiveness Analyses of Behavioral Interventions

Conducting Cost-Effectiveness Analyses of Behavioral Interventions. Todd H. Wagner, Ph.D. Mary K. Goldstein, M.D. Acknowledgements. Partial funding was through a grant from the National Cancer Institute (2PO1 CA 55112-05A1).

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Conducting Cost-Effectiveness Analyses of Behavioral Interventions

Conducting Cost-Effectiveness Analyses of Behavioral Interventions. Todd H. Wagner, Ph.D. Mary K. Goldstein, M.D. Acknowledgements. Partial funding was through a grant from the National Cancer Institute (2PO1 CA 55112-05A1).

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Webinar Host

Webinar Host. HOSTED BY: Ronan Fitzpatrick. Webinar Overview. Design Challenges Overview Accounting for Design Constraints Statistical Design Challenges Value of Flexible Design. Worked Examples Overview. Worked Examples. Two Means Group Sequential Trial Unblinded SSR Example

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Cancer Clinical Trials:

Cancer Clinical Trials:. In-Depth Information. The Drug Development and Approval Process. 1. Early research and preclinical testing 2. IND application filed with FDA 3. Clinical trials (phases 1, 2, and 3) 4. NDA filed with FDA 5. FDA validates claim and approves drug.

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Clinical Trial Preparation for Molecularly Based Agents

Clinical Trial Preparation for Molecularly Based Agents. Edward A. Sausville, M.D., Ph.D on behalf of Dr. Louise Grochow Chief, Investigational Drug Branch Cancer Therapy Evaluation Program National Cancer Institute. T. C. EP. T HEORY TO T HERAPY.

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ACC & i2 summit, March 15th 2010, Atlanta, Georgia

CILON-T Late Breaking Trial : Randomized prospective trial of dual vs. triple antiplatelet therapy after DES implantation. ACC & i2 summit, March 15th 2010, Atlanta, Georgia. Hyo-Soo Kim, MD, PhD Seoul National University Hospital Seoul, Korea. Nothing to disclose. CILON-T trial.

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Use of Archived Tissue in Evaluating the Medical Utility of Prognostic & Predictive Biomarkers

Use of Archived Tissue in Evaluating the Medical Utility of Prognostic & Predictive Biomarkers. Richard Simon, D.Sc. Chief, Biometric Research Branch National Cancer Institute http://brb.nci.nih.gov. Prognostic & Predictive Biomarkers.

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Lessons learned from CB1 blockers: did we try to crack a nut with a sledgehammer ?

Lessons learned from CB1 blockers: did we try to crack a nut with a sledgehammer ? . Prof. Renger F. Witkamp Nutrition and Pharmacology . Lancet, 2007. Clearly , these side- effects were not expected , but.... Where did it go wrong (if at all) ? Could (should) we have foreseen this ?

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Pediatric Psychopharmacology

Pediatric Psychopharmacology. National Institute of Mental Health. Child and Adolescent Treatment and Preventive Intervention Research Branch . Mission:

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Presented by Gregory Downing, Ph.D. at the Nonclinical Studies Subcommittee of the Advisory Committee for Pharmaceutica

Presented by Gregory Downing, Ph.D. at the Nonclinical Studies Subcommittee of the Advisory Committee for Pharmaceutical Science March 9, 2000. NIH Research Activities - Biomarkers and Surrogate Endpoints. BIOMARKERS NIH RESEARCH INTERESTS. Emerging bottlenecks in drug discovery

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Clinical Trial Design and other Statistical Issues

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When Should a Clinical Trial Design with Pre-Stratification be Used?

When Should a Clinical Trial Design with Pre-Stratification be Used?. Group 1. Stratification. Why? Achieve balance between groups on factors associated with the response (prognostic variables) How? Strata created based on prognostic factors Pre-Stratification

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Clinical Trial Design, Biostatistics, Ethics, and Recruitment

Clinical Trial Design, Biostatistics, Ethics, and Recruitment. Clinical Trial Design Anthony J. Murgo, MD.,MS; NCI/DCTD Biostatistics Larry Rubinstein, PhD; NCI/DCTD/BRB Ethical Considerations Holly Taylor, PhD,MPH; JHU Berman Bioethics Instit. David Wendler, PhD; NIH Clinical Center

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Stanford Program in Biodesign

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