'Surrogate endpoints' presentation slideshows

Curtis Meinert Keynote Lecture Society of Clinical Trials, 2019

Curtis Meinert Keynote Lecture Society of Clinical Trials, 2019. Striving to Achieve & Protect the Integrity of Clinical Trials May 20, 2019 Thomas R. Fleming, Ph.D. Professor, Dept. of Biostatistics University of Washington. Design, Conduct & Analysis of Clinical Trials:

531 views • 52 slides

Risk Management Programs

Risk Management Programs. FDA Experience and Evolving Guidances on Risk Management Practices . Anne Trontell, M.D., M.P.H. Deputy Director CDER Office of Drug Safety. Anesthetic & Life Support Drugs Advisory Committee September 9, 2003. FDA and Risk Management .

1.58k views • 50 slides

Statistical issues in the validation of surrogate endpoints

Statistical issues in the validation of surrogate endpoints. Stuart G. Baker, Sc.D. sb16i@nih.gov. Surrogate endpoint: definition. used to make conclusions about the effect of intervention on true endpoint obtained sooner, at less cost, or less invasively than the true endpoint. Outline.

362 views • 34 slides

Biomarkers and Subparts Rules and Exceptions

Biomarkers and Subparts Rules and Exceptions. James Witter MD, PhD Analgesic, Anti-inflammatory, and Ophthalmologic Drug Products HFD-550/ODEV/CDER/FDA. FDA and Medical Care. The FDA approves drug and biologic therapeutics for interstate commerce The FDA does not regulate medical care

605 views • 30 slides

Obstructive Sleep Apnea and Cardiovascular Disease: A Tale of Two Unhappy Bedfellows

Obstructive Sleep Apnea and Cardiovascular Disease: A Tale of Two Unhappy Bedfellows. Najib Ayas MD MPH Associate Professor of Medicine Sleep Disorders Program Critical Care and Respiratory Divisions University of British Columbia.

456 views • 23 slides

Surrogat - endepunkter: Teori og empiri

415 views • 22 slides

Economic evaluation of outcomes: long term primary and surrogate endpoints

Economic evaluation of outcomes: long term primary and surrogate endpoints. Dr. Giampiero Favato presented at the University Program in Health Economics Ragusa, 26-28 June 2008. Measuring health and disease. Many measures are used to assess health outcomes, ranging from:

302 views • 15 slides

Batten Disease

1.22k views • 14 slides

Translating Biomarker Discovery to Clinical Application

Translating Biomarker Discovery to Clinical Application. Sudhir Srivastava, Ph.D., M.P.H. Cancer Biomarkers Research Group. GOALS. Discover, develop and validate biomarkers for cancer detection, diagnosis and risk assessment

586 views • 13 slides

End-points utilized in breast cancer clinical trials - Discussion

Novartis Oncology. End-points utilized in breast cancer clinical trials - Discussion. Discussant - Arunava Chakravartty Stat4Onc Symposium , Hartford, CT Apr-26, 2019. Disclaimer.

260 views • 10 slides

European Statistical meeting on Oncology Thursday 24 th , June 2010

European Statistical meeting on Oncology Thursday 24 th , June 2010. Introduction - Challenges in development in Oncology H.U. Burger, Hoffmann-La Roche. Some challenges in Oncology. Early developments: Dose determination for safety and/or efficacy Proof of concept study designs

138 views • 10 slides