Educational Workshop: Contemporary Issues in Clinical Trials Methods

Friday, July 14, 2017
8 a.m. – 5 p.m.


This workshop will cover contemporary issues in clinical trials, which aid clinicians in selecting cost-effective trial designs. The workshop will cover: 1.) adaptive trial designs 2.) simulation and study enrichment 3.) categorical vs. continuous-time analysis model 4.) delayed start design. For each topic, lectures will start with an overview of basic concepts, followed by more advanced topics, using practical examples. The targeted audience is clinicians and statisticians. The workshop will utilize some programming languages, but the aim is for clinicians to deepen conceptual understanding, as well as to provide statisticians with available resources.

This workshop is organized by the Clinical Trials Advancement and Methods Professional Interest Area (PIA) of the Alzheimer's Association International Society to Advance Alzheimer's Research and Treatment (ISTAART).

Program Chairs


  • Time
  • Topics

8 – 8:05 a.m.

Opening Remarks

8:05 – 10:20 a.m.

SESSION I: How to Assess Outcomes/Endpoints – Continuous Time vs. Categorical Time
Michael Donohue, University of Southern California, United States

10:20 – 10:30 a.m.


10:30 – 11:50 a.m.

SESSION II, Part A: Simulation and Trial Enrichment
Jennie Leoutsakos, Johns Hopkins University, United States

11:50 a.m. – 1 p.m.

Lunch (included)

1 – 1:50 p.m.

SESSION II, Part B: Simulation and Trial Enrichment
Jennie Leoutsakos, Johns Hopkins University, United States

2 – 4:10 p.m.

SESSION III: Adaptive Trial Design
Joyce Chang, University of Pittsburgh, United States

4:10 – 4:20 p.m.


4:20 – 5 p.m.

Expedition Trial Design: Delayed Start Analyses (including Question and Answer):
Hong-Liu Seifert, Eli Lilly, United States

5 p.m.

Closing Remarks

Target Audience

This workshop can serve as a beginners’ or refresher course for established investigators, clinicians and trainees.


Educational workshops require a separate registration fee in addition to AAIC full conference registration, or may be purchased as a stand-alone event. View registration information.


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 (PIA), attend PIA Day scientific sessions (Saturday, July 15) and attend exclusive member-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 the online career center, monthly e-newsletters, networking forums and extended LOI deadlines for the Alzheimer's Association International Research Grant Program.

Non-members are encouraged to learn more and join ISTAART. Non-members may also join ISTAART during AAIC registration — select "Member +PLUS" or "Student Member +PLUS" as the AAIC registration category to purchase one year of ISTAART membership in addition to AAIC registration at the member rate. Available to new members only.


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July 16 – 20: Annual Conference
July 14 – 15: Preconferences
July 16 – 19: Exhibit Dates
London, England

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