July 2020 Webinar:

Introduction of U-Design v1.3Laiya Consulting, Inc.

July 22, 2020

https://udesign.laiyaconsulting.com

Agenda

• 11:00-11:05 Opening remarks

--- Meng Lan

• 11:05-12:05 Presentation

--- Dr. Yuan Ji

• 12:05-12:30 Q&A

2

Meng Lan, CTO

• Extensive experiences in software development, especially in the field of healthcare IT

• Assumed technical leadership roles in healthcare consulting projects and healthcare institutions in US

• Co-founded a healthcare startups as CTO in China

• Graduated from Baylor University with a master in computer science degree and holds a MBA from University of Texas

Speaker: Yuan Ji, Ph.D

• Founder of Laiya Consulting, Inc.

• Professor of Biostatistics (with tenure) at the University of Chicago

• Prolific researchers with over 140 papers on top biomedical and statistical journals

• Created many original innovative Bayesian adaptive designs such as the mTPI and i3+3 designs

• Early pioneers in the development of interval-based designs for dose-finding trials

• Elected fellow of the American Statistical Association.

U-Design – The best SaaS for trial designs

• U-Design key features:

• Head-to-head comparison of trial designs based on massive simulations (unique)

• Operating characteristics presented by advanced and interactive visualization

• Intelligent reports for submission packets and trial protocols

• Comprehensive user manual with in-depth descriptions of the statistical models

• New features in version 1.3:

• A brand new module for Bayesian basket trial designs

• Improved user manuals for the single-agent & dual-agents cohort-based dose finding designs

modules.

• Improved and intelligent reports for the single-agent cohort-based dose finding designs

module.

New Features in U-Design v1.3 (continued)

• Interface Enhancements:

• Termination of submitted simulations;

• Sorting multiple running simulations by launch time;

• Deletion of old simulation results;

• Automatic refreshment of simulation history to pull in new simulation results and better

display of messages showing the completion status of simulations;

• System Improvements:

• Magnitude faster computing speed with hardware upgrade and performance tunings

• Enhanced security for users, such as account lockdown for failed login, enabling secure and

http only cookies, scanning system periodically for security vulnerabilities, etc.

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Dose-finding designs over time

•

1989 1990 2007 2010 2013 2015

3+3 CRM TPI,CCD mTPI BOIN

2017

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Interval Designs

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ova

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l. (J

SPI)

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nes

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SIM

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BLRM

2008 2019

i3+3

Rule-BasedDesigns

Non-intervalDesigns

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JBS)

Yan

et

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CC

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Model-Based Designs

1989 3+3

CRM

mTPI-2

mTPI

TPI CCD

BOIN

i3+32019

Rules

Complex

Models

Simplified

Models

1990

2007

2010

2015

2017

EWOC1998

BLRM2008

Time

Sp

ira

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vo

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n

7

Master protocols

Ran

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miz

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Control

HE

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# HistologiesK1

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R2 Ib

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Time

# Tr

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1 2-arm RCT

1 Umbrella trial

K Basket trial

K Platform trial

8

Examples: A Basket

Trial

9

Basket Trial Designs (1)

10

Borrowing information

11

MUCE – next-generation Bayesian

designs for multi-arm trials

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https://arxiv.org/abs/2006.07785

Demo time

Thank you!