Educational Workshop: Contemporary Issues in Clinical Trials Methods

Friday, July 12, 2019
8 a.m. – 5 p.m.
Los Angeles, USA

Overview

This workshop will discuss contemporary issues in clinical trials, which aid clinicians in selecting cost-effective trial designs. Topics include simulation concept and trial enrichment, Bayesian thinking and adaptive trial designs and multiple comparisons and related topics. Instructors from both industry and academia will present. For each topic, lectures will start with an overview of basic concepts, followed by more advanced topics, using practical examples. Each year, examples using new data by different instructors are provided so that repeat attendees have the opportunity to gain new knowledge.

This workshop was organized by the ISTAART Clinical Trials Advancement and Methods PIA.

Organizing Committee


Agenda
  • Time
  • Topics

8 a.m.

Opening Remarks
Hiroko Dodge, University of Michigan and Oregon Health & Science University


8:10 a.m.

Simulation Concept and Enrichment
Jeannie Leoutsakos, Johns Hopkins Bloomberg School of Public Health


9:50 a.m.

Bayesian Thinking and Adaptive Trial Designs: Using Real-World Examples
Jian Zhou, Takeda


11:50 a.m.

Lunch (included)


1 p.m.

Multiple Comparisons and Related Topics
Jason Hsu, Emeritus Professor, Ohio State University

  1. Why do we need multiple comparison adjustments?
  2. Concepts of error rates: Per comparison, familywise, per family, FDR
  3. Endpoints: Alternative primary, co-primary, secondary, exploratory
  4. Principles and methods: Closed testing (Holm, Hochberg, etc.), partitioning, graphical approach
  5. FDA and EMA guidelines
  6. Observational studies versus randomized clinical trials (current issue with estimands)
  7. Biomarkers, targeted therapy, subgroups, GWAS


4 p.m.

Introduction of Graphical User Interface (GUI) Software Developed by Critical Path for Alzheimer's Disease (CPAD)
Daniella Conrad, CPAD


5 p.m.

Closing Remarks


Target Audience

Clinicians and statisticians. Behavioral interventionists are also encouraged to attend.

Registration

Educational workshops come with separate registration fees in addition to AAIC full conference registration. Workshops can also be purchased as stand-alone events. Registration for this workshop will open in February.

About ISTAART

ISTAART logoThe Alzheimer's Association International Society to Advance Alzheimer's Research and Treatment (ISTAART) is a professional society for individuals interested in Alzheimer's and dementia science — including scientists, physicians and other professionals involved in the causes and treatments of Alzheimer's disease and other dementias.

ISTAART membership makes AAIC even better: Receive discounted registration, participate in Professional Interest Areas (PIAs), attend PIA Day scientific sessions before AAIC begins and get access to exclusive members-only scientific and networking events. Members also receive ongoing benefits throughout the year, including an online monthly subscription to Alzheimer's & Dementia®: The Journal of the Alzheimer's Association, free online access to Neurobiology of Aging, access to an online career center, monthly e-newsletters, networking forums and extended LOI deadlines for the Alzheimer's Association International Research Grant Program.

Learn more and join ISTAART. New members can also join ISTAART during AAIC registration: Select “ISTAART Membership + AAIC Registration” as the AAIC registration category to purchase one year of ISTAART membership in addition to AAIC registration at the member rate.

Join the Conversation #AAIC19

Follow

Exhibitors

Exhibitors

Sponsors

Sponsorship

> 1200px
lg
> 992px
md
> 768px
sm
< 767px
xs