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Adaptive Trials
Early/iterative analysis
(drug or biomarker
working?)
Stopping
rule met?
Revise allocation
per algorithm
e.g. randomize
more to Drug A
arm
Continue data
collection
Adaptive algorithm
Stop trial or
begin next
phase
Yes
No
•
Good
:
–
Pick-a-winner
–
Can adapt on drug or biomarker
–
Smaller, conserve resources
•
Bad
:
–
Interim estimates=
error risk
–
Complicated! Continuously
collecting response data
–
If biomarker-based
•
Must be validated.
•
Need real-time results
•
Cannot do discovery
Example: ISPY2 - novel biologics in
combination with chemotherapy