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Housekeeping Points
Dr Don Richards Don
Glossary about Clinical Trials
Phase One Clinical Trials for Drugs
Placebo
Costs of the Clinical Trial
Liabilities
Observational Studies
What Would You Say Are the Largest Barriers for Patients To Consider When Uh Join Your Face Rather When Joining a Clinical Trial
General Information
Discussion overview and introductions
Opening remarks from Jeffrey Drazen, editor-in-chief, NEJM Evidence
Adam Dunn: Using AI to improve the design, reporting, and synthesis of clinical trials
Qiang Zhao: Design of an AI-assisted QFR-guided CABG trial
Arnaub Chatterjee: Applications of AI to improve trial design and probability of success
panel questions (panelists: Junbo Ge, Shengxian Tu, and Yunpeng Zhu)
Introducing Sebastian Unizony, MD.
What is Giant Cell Arteritis (GCA)?
How GCA commonly presents.
Current treatments.
Questions about GCA.
Q: After being on a treatment plan for two years with no flares is there a chance of losing vision as prednisone is reduced?
Q: What is the most common diagnostic test used for monitoring ongoing disease?
Q: Are there any genetic depositions for GCA?
Audience Survey: Experience with clinical studies.
Understanding clinical trials.
Studying treatment options for GCA.
Clinical Trials 101-- A Glossary.
Ethical and scientific principles and guidelines.
Vasculitis clinical trials.
Abatacept (orenica) for GCA.
Mavrilimumab for GCA.
Ongoing study of abatacept.
Ongoing study of upadacitinib (rinvoq).
Ongoing study of guselkumab (tremfya).
GUSTO Study (Switzerland) Can we use less than six months of steroids?
Ultimate goal of clinical trials in GCA in the near future.
Three online resources.
Are newly diagnosed patients allowed to participate in clinical studies?
Why should I participate in a clinical study if my current treatment protocol is working?
Thank you and wrap up.
The long-term goal
How long are people going to participate in this trial?
Q: How many people are in the cohort study that are waiting to join the trial?
What exactly is a clinical trial protocol?
Protocol: Other Elements
Study Design
Why do we want healthy individuals for vaccine trials?
Why is it important to reach out to diverse populations?
Range of Doses
Conclusion
Terminated studies
Using filters to find studies
What is the difference between interventional and observational studies?
Example of finding a study
Estimated Enrollment and Eligibility
How to find a contact person for a study
What states are represented?
What if you don't find a contact person?
ClinicalTrialGuru Producers
Disclaimer
Steps and Stages of Approval in the Clinical Trials Process
Inclusion Criteria
History of Car T Cells
Rate of Cytokine Release Syndrome
Poll Questions
Immune Effector Cell Associated Neurotoxicity Syndrome
What Most Interests You about Card T Cell Therapy from Myasthenia Gravis
Kava 201 Trial for Generalized Myasthenia Gravis
Closing