Educational Workshop: Contemporary Issues in Clinical Trials Methods

Friday, July 12, 2019
8 a.m. – 5 p.m.
Intercontinental Los Angeles Downtown Hotel, Silver Lake


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

  • 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 University, School of Medicine and Bloomberg School of Public Health

9:50 a.m.

Bayesian Thinking and Adaptive Trial Designs: Using Real-World Examples
Jian Zhu, 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 the Critical Path for Alzheimer's Disease Consortium (Quantitative Medicine, Critical Path Institute, CPAD)
Jackson Burton and Klaus Romero

5 p.m.

Closing Remarks

Target Audience

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


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 opened in February.


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.

Call for Abstracts

Our Scientific Program Committee is accepting abstracts for poster presentations, oral sessions and featured research sessions until January 27. Need more time? Become an ISTAART member and extend your deadline until January 31.


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