Display event - SCT 2021 Virtual Annual Meeting

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SCT 2021 Virtual Annual Meeting

When

5/17/2021 - 5/20/2021

Where

Virtual

Select programs by

Monday, 17 May 2021


Click "Add" If You Are a First Time Attendee Time 5/17/2021 10:00 AM - 5/20/2021 3:00 PM 10:00 AM
W-1 Biomarker Driven Trials for Precision Medicine Presenter(s): Halabi, Susan (Duke University); Redman, Mary (Fred Hutch). Goals of session: This workshop will provide a basic exposition of the methods involved in the design of biomarker-driven trials. At the end of the workshop participants will: understand the different types of biomarkers, be able to choose the optimal design for different biomarkers, consider which population to study, identify which endpoint is reasonable, consider different schemes on how allocate the type I error rate and learn how to analyze and best present the results. Time 1:00 PM - 3:00 PM 1:00 PM

Click "Add" If You Are a First Time Attendee

Time

5/17/2021 10:00 AM - 5/20/2021 3:00 PM

10:00 AM

W-1 Biomarker Driven Trials for Precision Medicine

Presenter(s): Halabi, Susan (Duke University); Redman, Mary (Fred Hutch). Goals of session: This workshop will provide a basic exposition of the methods involved in the design of biomarker-driven trials. At the end of the workshop participants will: understand the different types of biomarkers, be able to choose the optimal design for different biomarkers, consider which population to study, identify which endpoint is reasonable, consider different schemes on how allocate the type I error rate and learn how to analyze and best present the results.

Time

1:00 PM - 3:00 PM

1:00 PM

Tuesday, 18 May 2021


W-2 Designing Clinical Trials With Multiple Endpoints Presenter(s): Luo, Sheng (Duke University); Yuan, Ying (University of Texas MD Anderson Cancer Center). Goals of session: The core goal is to introduce state-of-the-art methods to design clinical trials with multiple endpoints and their applications using high-profile pivotal trials (e.g., Impassion 130, IMbrave 150, IMpower 133) published in New England Journal of Medicine. By the end of the session, participants will be able to: (1) understand the features and challenges of multiple endpoints; (2) master statistical methods to address the challenges of multiple endpoints; and (3) apply the introduced methods to design phase II and III trials with multiple endpoints. Time 1:00 PM - 3:00 PM 1:00 PM

W-2 Designing Clinical Trials With Multiple Endpoints

Presenter(s): Luo, Sheng (Duke University); Yuan, Ying (University of Texas MD Anderson Cancer Center). Goals of session: The core goal is to introduce state-of-the-art methods to design clinical trials with multiple endpoints and their applications using high-profile pivotal trials (e.g., Impassion 130, IMbrave 150, IMpower 133) published in New England Journal of Medicine. By the end of the session, participants will be able to: (1) understand the features and challenges of multiple endpoints; (2) master statistical methods to address the challenges of multiple endpoints; and (3) apply the introduced methods to design phase II and III trials with multiple endpoints.

Time

1:00 PM - 3:00 PM

1:00 PM

Wednesday, 19 May 2021


W-3 Designing Clinical Research Using Value of Information Presenter(s): Heath, Anna (The Hospital for Sick Children); Kunst, Natalia (Harvard Medical School); Jalal, Hawre (University of Pittsburgh); Welton, Nicky (University of Bristol). Goals of session: This course will introduce VoI measures and their use in research prioritisation and trial design. By the end of the course, participants will be able to (a) understand how VoI analysis can be used to determine research priorities and design clinical research, (b) interpret four key VoI measures, the Expected Value of Perfect Information (EVPI), the Expected Value of Perfect Partial Information (EVPPI), the Expected Value of Sample Information (EVSI) and the Expected Net Benefit of Sampling (ENBS), (c) discuss key assumptions that impact a VoI analysis, (d) explore the results of a VoI analysis using graphical displays. Time 10:00 AM - 12:00 PM 10:00 AM
W-4 Essentials of Clinical Trials Presenter(s): Rosenberg, Yves (NHLBI/NIH); Ecklund, Dixie (University of Iowa); Qidwai, Julie (Veristat); Coffey, Christopher (University of Iowa). Goals of session: Attendees should be able to describe the rationale and key design elements of a clinical trial, the essential principles of data management and quality control, as well as the essential ethical concepts and regulatory issues related to the design and conduct of clinical trials, including trials performed during a pandemic, and use this knowledge to successfully contribute as a researcher or collaborator in the one or more stage of a clinical trial. Time 1:00 PM - 3:00 PM 1:00 PM

W-3 Designing Clinical Research Using Value of Information

Presenter(s): Heath, Anna (The Hospital for Sick Children); Kunst, Natalia (Harvard Medical School); Jalal, Hawre (University of Pittsburgh); Welton, Nicky (University of Bristol). Goals of session: This course will introduce VoI measures and their use in research prioritisation and trial design. By the end of the course, participants will be able to (a) understand how VoI analysis can be used to determine research priorities and design clinical research, (b) interpret four key VoI measures, the Expected Value of Perfect Information (EVPI), the Expected Value of Perfect Partial Information (EVPPI), the Expected Value of Sample Information (EVSI) and the Expected Net Benefit of Sampling (ENBS), (c) discuss key assumptions that impact a VoI analysis, (d) explore the results of a VoI analysis using graphical displays.

Time

10:00 AM - 12:00 PM

10:00 AM

W-4 Essentials of Clinical Trials

Presenter(s): Rosenberg, Yves (NHLBI/NIH); Ecklund, Dixie (University of Iowa); Qidwai, Julie (Veristat); Coffey, Christopher (University of Iowa). Goals of session: Attendees should be able to describe the rationale and key design elements of a clinical trial, the essential principles of data management and quality control, as well as the essential ethical concepts and regulatory issues related to the design and conduct of clinical trials, including trials performed during a pandemic, and use this knowledge to successfully contribute as a researcher or collaborator in the one or more stage of a clinical trial.

Time

1:00 PM - 3:00 PM

1:00 PM

Thursday, 20 May 2021


W-5 The Estimand Addendum to the ICH E9 Guideline Presenter(s): Englert, Stefan (AbbVie Inc.); Siegel, Jonathan (Bayer); Liu, Feng (AstraZeneca); Sun, Steven (Johnson & Johnson). Goals of session: The goal of this session is to bring all disciplines together and maximize awareness of the ICH E9 addendum as well as demonstrate how it helps interdisciplinary teams to formulate clinical trial objectives, design, conduct, primary, secondary, and sensitivity analyses, as well as conclusions. Time 1:00 PM - 2:30 PM 1:00 PM
W-6 Accelerating Evidence Generation Thru Quality By Design Presenter(s): Hallinan, Zachary (CTTI). Goals of session: Bring forward a new way of designing better protocols. Time 1:00 PM - 2:30 PM 1:00 PM

W-5 The Estimand Addendum to the ICH E9 Guideline

Presenter(s): Englert, Stefan (AbbVie Inc.); Siegel, Jonathan (Bayer); Liu, Feng (AstraZeneca); Sun, Steven (Johnson & Johnson). Goals of session: The goal of this session is to bring all disciplines together and maximize awareness of the ICH E9 addendum as well as demonstrate how it helps interdisciplinary teams to formulate clinical trial objectives, design, conduct, primary, secondary, and sensitivity analyses, as well as conclusions.

Time

1:00 PM - 2:30 PM

1:00 PM

W-6 Accelerating Evidence Generation Thru Quality By Design

Presenter(s): Hallinan, Zachary (CTTI). Goals of session: Bring forward a new way of designing better protocols.

Time

1:00 PM - 2:30 PM

1:00 PM

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