2018 ASA Traveling Short Course
Co-sponsored by UCSF Cancer Center Biostatistics Core
ÒRandomized Clinical Trials –
Replacing Traditional Analyses with Better AlternativesÓ
Instructor: Dr. Devan V. Mehrotra, Merck Research Laboratories
When: |
Wednesday, June 20th, 2018, 9:00 am – 3:30 pm Sign-in at 8:45am |
Where: |
Mission Hall Room 1401 & 1402 UCSF Mission Bay Campus 550 16th Street, San Francisco, CA 94158 |
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:
8:45 –
9:00 am |
Sign-in |
9:00 – 9:10 am |
Introduction |
9:10 – 9:45 am |
Crossover trials with baseline responses |
9:45 – 10:30 am |
Thorough QT studies and PK/QTc modeling |
10:30 –
10:45 am |
Break |
10:45 – 11:15 am |
Small trials with time-to-event endpoints |
11:15 – 12:15 pm |
Pharmacogenomics in phase 2-3 trials |
12:15 –
1:15 pm |
LUNCH |
1:15 – 2:30 pm |
Stratified trials: binary and time-to-event
endpoints |
2:30 – 2:45
pm |
Break |
2:45 – 3:25 pm |
Estimand-aligned primary and sensitivity analyses |
3:25 – 3:30 pm |
Wrap-up |
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.
How to
Register: |
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. |
Registration
Fee: |
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. |
Parking: |
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: á
0-1 Hours = $4 á
1-2 Hours = $8 á
2-3 Hours = $12 á
3-4 Hours = $16 á
4-5 Hours = $20 (24-hour comp sticker rate) á
5-6 Hours = $24 á
6-7 Hours = $28 á
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 |