2018 ASA Traveling Short Course
Co-sponsored by UCSF Cancer Center Biostatistics Core
“Randomized Clinical Trials – Replacing Traditional Analyses with Better Alternatives”
Instructor: Dr. Devan V. Mehrotra, Merck Research Laboratories
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When:
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Wednesday, June 20th, 2018, 9:00 am – 3:30 pm
Sign-in at 8:45am
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Where:
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Mission Hall Room 1401 & 1402
UCSF Mission Bay Campus
550 16th Street, San Francisco, CA 94158
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Course Description:
Increased efficiency in the clinical drug development process can deliver downstream benefits to multiple stakeholders in the healthcare ecosystem including patients, prescribers, and payers. Value-added statistical contributions on that front can be made, in part, by developing and implementing analyses of randomized clinical trials that are notably better than their traditional counterparts. In this 1-day course, I will present examples of efficiency-boosting statistical approaches across all phases of clinical drug development. To appeal to a broad audience, the following six diverse topics will be covered: (i) crossover trials with baseline measurements, (ii) Thorough QT (TQT) studies and PK/QTc modeling, (iii) analyses of time-to-event endpoints with small sample sizes, (iv) pharmacogenomics to enable personalized medicine, (v) analyses of stratified trials with binary or time-to-event endpoints, and (vi) estimand-aligned primary and sensitivity analyses of continuous endpoints with missing data. For each topic, the key points will be amplified using real examples and simulations. All the methods discussed can be easily implemented using SAS and/or R code.
Course Agenda:
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8:45 – 9:00 am
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Sign-in
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9:00 – 9:10 am
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Introduction
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9:10 – 9:45 am
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Crossover trials with baseline responses
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9:45 – 10:30 am
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Thorough QT studies and PK/QTc modeling
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10:30 – 10:45 am
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Break
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10:45 – 11:15 am
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Small trials with time-to-event endpoints
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11:15 – 12:15 pm
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Pharmacogenomics in phase 2-3 trials
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12:15 – 1:15 pm
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LUNCH
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1:15 – 2:30 pm
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Stratified trials: binary and time-to-event endpoints
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2:30 – 2:45 pm
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Break
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2:45 – 3:25 pm
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Estimand-aligned primary and sensitivity analyses
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3:25 – 3:30 pm
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Wrap-up
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About the Instructor:
Dr. Devan V. Mehrotra is Associate Vice President, Clinical Biostatistics, and a Presidential Fellow at Merck Research Laboratories. Over the past 25+ years, he has made scientific and strategic contributions towards the research, development and regulatory approval of medical drugs and vaccines across a broad spectrum of therapeutic areas. He is an Adjunct Associate Professor of Biostatistics at the University of Pennsylvania, an Associate Editor for The American Statistician and Pharmaceutical Statistics, an elected Fellow of the American Statistical Association, and a 7-time winner of the best biopharmaceutical paper award at the annual Joint Statistical Meetings. Dr. Mehrotra has served as a subject matter expert for the Bill and Melinda Gates Foundation and for the US National Academy of Sciences, and he is a member of the ICH E9/R1 expert working group that has developed draft guidance on estimands and sensitivity analyses for clinical trials. His current focus areas include the use of statistical/machine learning tools and pharmacogenomics for enabling personalized/precision medicine.
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How to Register:
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Please use the following link for registration:
https://www.123signup.com/register?id=hyzpq
Please register by Friday, June 15th.
On-site registration will not be available.
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Registration Fee:
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ASA members/SFASA chapter members: $320
Students/Postdocs: $160
Non-members: $440
The registration fee includes course materials, light refreshments during coffee breaks, and a lunch box, but does not include parking.
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Parking:
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UCSF Mission Bay Campus offers multiple parking options.
1835 Owens Street Garage
Located across from the Mission Bay Hospital
1625 Owens Street/Rutter Center Garage
Located next to the Mission Bay Community Center
1650 Third Street Garage
Located just north of 16th Street
* Garage is permit only weekdays 8:00pm – 7:00am and all day on weekends and UC holidays
Opening Summer 2017: Nelson Rising Lane surface lot 1
Located on the northwest side of the UCSF Mission Bay Campus. Enter via Nelson Rising Lane
Public parking rates at Mission Bay are as follows:
· 0-1 Hours = $4
· 1-2 Hours = $8
· 2-3 Hours = $12
· 3-4 Hours = $16
· 4-5 Hours = $20 (24-hour comp sticker rate)
· 5-6 Hours = $24
· 6-7 Hours = $28
· 7-24 Hours = $32 (daily maximum)
For more information, see http://campuslifeservices.ucsf.edu/transportation/services/parking/public_parking
Meter parking is $1.50/hour (maximum time 4 hours). For event day (such as Giants Game), parking can be $7/hour.
For Mission Bay Public Transit Options (by Muni, Bart, Caltrain, etc.), see https://campuslifeservices.ucsf.edu/transportation/services/alternative_transportation/mission_bay_transit_options
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