Conference for Innovative Designs of Clinical Trials and Related Topics
June 19-20, 2009
Freidenrich Auditorium
Lucile Packard Children's Hospital
Stanford
Overview
This conference is being organized by the Division of Biostatistics and the
Center for Innovative Study Design of the School of Medicine at Stanford.
It will be held June 19-20 at Lucile Packard Children's Hospital.
The organizing committee consists of
Tze Leung Lai, Philip Lavori, Richard Olshen, and
Mei-Chiung Shih (Chair).
The conference features speakers from academia, industry, and the regulatory
agency. Its goal is the exchange of ideas between clinical researchers and
biostatisticians concerning the development, planning, execution, and
statistical analyses of innovative designs in clinical trials to meet
emerging needs in the prevention and treatment of human disease.
Preliminary Program
(printable version)
Friday, June 19, 2009
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| 09:15 | Philip Lavori |
Stanford |
Opening Remarks |
Session I (Chair: Richard Olshen) |
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| 09:20 | Robert Negrin |
Stanford |
Regulatory T cells from the bench to the clinic |
10:00 |
Sandy Srinivas |
Stanford |
Challenges in clinical trial designs in prostate cancer |
10:40 |
Tyler Martin |
Dynavax |
Innovative and accelerated development of an improved therapeutic for cystic fibrosis: Tobramycin inhalation powder |
11:20 |
Philip Lavori |
Stanford |
Effectiveness Experiments: challenges and new
directions |
12:00 |
Lunch |
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Session II (Chair: Corry Dekker) |
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01:50 |
Anne-Marie Duliege |
Affymax |
Safety assessment during the development of new drugs: new challenges and statistical considerations |
02:30 |
Joseph Heyse |
Merck |
Application of sequential stopping boundaries in vaccine safety trials |
03:10 |
Bruce Fireman |
Kaiser Permanente |
Influenza vaccination and mortality: a novel approach to differentiating vaccine effects from bias |
03:50 |
Break |
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Session III (Chair: Philip Lavori) |
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04:00 |
Corry Dekker |
Stanford |
Influenza A/H1N1 (Swine flu) |
04:40 |
Balasubramanian Narasimhan |
Stanford |
Statistical software for designing Phase I/II cancer studies |
Saturday, June 20, 2009 |
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Session IV (Chair: Ying Lu)
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08:15 |
Sue-Jane Wang |
FDA |
How might adaptive design be useful to learn biomarker predictivity versus to test treatment effect potentially predicted by genomic biomarker classifier? |
08:55 |
Ray Zhu |
Eisai |
Using regret concept in planning of clinical development of new drugs |
09:35 |
Mei-Chiung Shih |
Stanford |
A strategic approach to designing Phase II cancer studies |
10:15 |
Break |
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Session V (Chair: Mei-Chiung Shih) |
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10:30 |
Janet Wittes |
Statistics Collaborative |
Adaptive designs: Gaming the system |
11:10 |
Gordon Lan |
Johnson & Johnson |
The use of conditional power and predictive power in clinical trials |
11:50 |
Eric Holmgren |
Genentech |
Extending a study beyond its "final" analysis |
12:30 |
Lunch |
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Session VI (Panel Discussion)
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1:30 - 3:00 |
Emerging issues in the design and analysis of clinical trials |
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Dan Anbar |
DANA Pharmaceutical Consulting |
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| Agnes Hsiung | NHRI, Taiwan |
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Tze Leung Lai |
Stanford |
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Registration
Attendance is limited, and early registration is encouraged. The registration
fee is $70 for non-Stanford individuals. Non-Stanford attendees
should register by mail by June 5, 2009.
Complete registration instructions are found on the
Registration Form (in pdf format).
For Stanford faculty, staff and students, please send email to
to register. Please also indicate the date(s)
that you are attending.
Accommodation
Summer is a busy time of year in Palo Alto, and we encourage you to plan
your lodging accordingly. Accommodation information can be found at:
http://www.stanford.edu/dept/rde/chs/general/hotel.html
Transportation
Stanford is accessible easily from anywhere in the San Francisco Bay area.
A printable visitor map can be found at
http://www.stanford.edu/dept/visitorinfo/plan/maps.html.
San Francisco International Airport (SFO) and San Jose International
Airport (SJC) are both within 25 miles of Palo Alto. Together, they
are served by all major airlines. Major car rental companies are
available at both airports, and other transportation can be found
on the following websites:
SFO:
http://www.flysfo.com/web/page/tofrom/transp-serv/to-sb/
SJO:
http://www.sjc.org/travelers/public.html
Post-conference Symposium
ICSA 2009 Applied Statistics Symposium
June 21-24, San Francisco, CA
For additional information, contact:
Bonnie Chung
Email: bchung@stanford.edu
Phone: (650) 723-5301
Fax: (650) 725-6951
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