Clinical Trials Course Online
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Instructions to Access Content
- Click here and click on Clinical Trials for Immunologic Disease.
- Click Add to Basket on the right side of the page.
- Click on the Clinical Trials course.
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- Choose if you would like access to the content only, or if you would like to claim CME credit.
- After submitting the order, click on Continue to My Content.
- Select the video to watch and pause to complete the pre-test.
- Click on Submit Credit at any point to print your CME certificate. Before you can print the certificate, you will be asked to complete the post-test and evaluation.
This is a basic course in clinical trial methodology, particularly as it relates to immunologic disease. It reviews the key elements of clinical trials, including types of trials, designing feasible trials, statistical issues, and surrogate markers that might be used. It discusses strategies for entering into the funding stream. A practicum is offered to participants using a model scenario in order to work through the issues one faces in developing a clinical trial.
The content of this webinar was captured during the live Clinical Trials for Immunologic Disease course, June 23, 2012 in Vancouver, Canada. The estimated time to complete this activity is 6 hours.
Date of Release
This activity was released on August 15, 2012. It is available for CME credit until August 15, 2015.
Upon completion of this activity, the participant should be able to:
- Discuss the key elements of clinical trials, including the essential components and regulatory overview.
- Identify the different stages of drug development, including the phases of clinical trials.
- Analyze the feasibility of proposed clinical trials.
- Define the common statistical issues in clinical trials, including but not limited to Type I and Type II errors.
- Recognize the importance of surrogate markers in immunologic monitoring.
- Welcome & Overview - Robert B. Nussenblatt, MD, National Eye Institute/National Institutes of Health
- Key Elements of Clinical Trials - Anne S. Lindblad, PhD, EMMES Corportation
- Types of Clinical Trials - Robert B. Nussenblatt, MD, National Eye Institute/National Institutes of Health
- Designing Phase I and Phase II Clinical Trials - Carla J. Greenbaum, MD, Benaroya Research Institute
- Surrogate Markers in Immunology - Laurence Turka, MD, Immune Tolerance Network
- Practical Statistical Issues in Clinical Trial Management - Darby Thompson, PhD, EMMES Corporation
- The Research Subject: Designing Feasible Trials - Carla J. Greenbaum, MD, Benaroya Research Institute
- Entering the Funding Stream: Writing and Getting Clinical Grants - Daniel Rotrosen, MD, National Institute of Allergy and Infectious Diseases/National Institutes of HealthP
- Participant Practicum with Mentors
- Discussion of Studies Proposed - Participants and Faculty
- Closing Remarks - Scott Plevy, MD, University of North Carolina at Chapel Hill
The Federation of Clinical Immunology Societies is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education credits for physicians.
The Federation of Clinical Immunology Societies designates this educational activity for a maximum of 6 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
- Anne Lindblad - Part owner of the EMMES Corporation
- Scott Plevy, MD - Abbott Immunology, Biomodels, Inc., CalciMedica, Inc., Drais Pharmaceuticals, enGene, Inc., Genentech, Human Genome Sciences, Janssen Biotech, Novartis, Novo Nordisk, NPS Pharmaceuticals, Pfizer, Protagonist Therapeutics, Inc., Receptos, Shire, Synergy Pharmaceuticals, Takeda Pharmaceuticals, Vertex Pharmaceuticals, TransTech Pharmaceuticals, Prometheus Laboratories: Consulting fees; Prometheus Laboratories: Royalties, grant support; Abbott Immunology, Janssen Biotech, Inc., Salix Pharmaceuticals, Inc., UCB: Honoraria; Abbott, Janssen Biotech: Trainee salary support
This course was supported by unrestricted educational grants from Abbott, Amgen, Boehringer Ingelheim, Genentech, National Institutes of Health, Pfizer and UCB.
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