Mr. Peter Bruce is President of The Institute
for Statistics Education at Statistics.com, if you flip a coin hundreds of
times, there are sure to be points at which the proportion of heads or tails
seems high. It is this phenomenon that makes it tricky to stop a clinical trial
part way through, and claim success with statistical validity. The statistical
design protocol must allow for flexible endpoints, and this flexibility must be
paid for with more stringent alpha levels. Flexible (adaptive) designs are increasingly
popular - learn more with Vidyadhar Phadke in his online course, "Adaptive
Designs for Clinical Trials," at Statistics.com. For more details
please visit at http://www.statistics.com/adaptive/.
Classic statistical study designs have static
features (sample size, allocation scheme, etc.) that don't let you take
advantage of new information that comes in during a clinical trial. Adaptive
designs let you modify the characteristics of ongoing trials based on interim
results in the study. Adaptive designs increase the probability of success,
reduce costs and the time to market, and promote accurate drug delivery to
patients. However, they must be done properly to preserve statistical validity.
"Adaptive Designs for Clinical
Trials" will introduce the adaptive design theory and the hands-on
techniques for planning, designing, monitoring, and analyzing adaptive trials.
It covers sample-size re-estimation, drop-loser, biomarker-adaptive design, and
response-adaptive randomization designs.
Who Should Take
This Course:
Statisticians with responsibility for
designing, analyzing and reporting clinical trials.
Course Program:
Course outline: The course
is structured as follows
SESSION 1:
- General
Concept
- Fundamental
Theory
- Group
Sequential Design
- Adaptive
Interim Analysis in Clinical Trials
SESSION 2:
- Adaptive
Dose Finding Design
- Enrichment
Design for Target Clinical Trials
SESSION 3:
- Two-Stage
Adaptive Design
- Sample
size estimation/allocation
SESSION 4:
- Protocol
Amendments
- Clinical
Trial Simulation
- Efficiency
of Adaptive Design
- Case
Studies
Dr. Vidyadhar Phadke, instructor, is a Senior
Statistician with Cytel, Inc. the leading provider of clinical trial design
services and a pioneer in the area of adaptive design.
Participants can ask questions and exchange
comments with Dr. Phadke via a private discussion board throughout the period.
The course takes place online at statistics.com in a series of 4 weekly lessons
and assignments, and requires about 15 hours/week. Participate at your own
convenience; there are no set times when you are required to be online.
For Indian participants statistics.com accepts registration for its courses
at special prices in Indian Rupees through its partner, the Center for
eLearning and Training (C-eLT), Pune.
Call: 020 66009116
Websites:
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