Type of adaptive designs |
Type of adaptive designs |
Type of adaptive designs |
Definition |
Definition |
Definition |
Group sequential |
Group sequential |
Group sequential |
It allows for 1
or more prospectively planned interim analyses of comparative data with
prespecified criteria for stopping the trial [5] |
It allows for 1
or more prospectively planned interim analyses of comparative data with
prespecified criteria for stopping the trial [5] |
It allows for 1
or more prospectively planned interim analyses of comparative data with
prespecified criteria for stopping the trial [5] |
Adaptations to the sample size |
Adaptations to the sample size |
Adaptations to the sample size |
It prospectively planned modifications
to the sample size based on interim estimates of nuisance parameters
from analyses that use treatment assignment information [5] |
It
prospectively planned modifications to the sample size based on interim
estimates of nuisance parameters from analyses that use treatment
assignment information [5] |
It prospectively planned modifications
to the sample size based on interim estimates of nuisance parameters
from analyses that use treatment assignment information
[5] |
Sample size re-estimation |
Sample size re-estimation |
Sample size
re-estimation |
It prospectively planned modifications to the sample
size based on comparative interim results (incorporating information
about treatment assignment) or noncomparative data (without including
treatment assignment) [5] |
It prospectively planned modifications
to the sample size based on comparative interim results (incorporating
information about treatment assignment) or noncomparative data (without
including treatment assignment) [5] |
It prospectively planned
modifications to the sample size based on comparative interim results
(incorporating information about treatment assignment) or noncomparative
data (without including treatment assignment) [5] |
Adaptations to the patient population (e.g., adaptive enrichment) |
Adaptations to the patient population (e.g., adaptive enrichment) |
Adaptations to the patient population (e.g., adaptive enrichment) |
It
allows adaptive modifications to the patient population based on
comparative interim results; for example, a trial might enroll
participants from the overall trial population up through an interim
analysis, at which time a decision will be made based on prespecified
criteria whether to continue enrollment in the overall population or to
restrict future enrollment to the targeted subpopulation [5] |
It
allows adaptive modifications to the patient population based on
comparative interim results; for example, a trial might enroll
participants from the overall trial population up through an interim
analysis, at which time a decision will be made based on prespecified
criteria whether to continue enrollment in the overall population or to
restrict future enrollment to the targeted subpopulation [5] |
It
allows adaptive modifications to the patient population based on
comparative interim results; for example, a trial might enroll
participants from the overall trial population up through an interim
analysis, at which time a decision will be made based on prespecified
criteria whether to continue enrollment in the overall population or to
restrict future enrollment to the targeted subpopulation
[5] |
Adaptive dose-ranging |
Adaptive dose-ranging |
Adaptive dose-ranging |
It begins with several doses and incorporates interim analyses based on
comparative data to select doses for continued evaluation, with the goal
of providing an improved characterization of the dose–response
relationship relative to a nonadaptive design and allowing the selection
of an optimal dose or doses for evaluation in future confirmatory trials
[5] |
It begins with several doses and incorporates interim analyses
based on comparative data to select doses for continued evaluation, with
the goal of providing an improved characterization of the dose–response
relationship relative to a nonadaptive design and allowing the selection
of an optimal dose or doses for evaluation in future confirmatory trials
[5] |
It begins with several doses and incorporates interim analyses
based on comparative data to select doses for continued evaluation, with
the goal of providing an improved characterization of the dose–response
relationship relative to a nonadaptive design and allowing the selection
of an optimal dose or doses for evaluation in future confirmatory trials
[5] |
Adaptations to treatment arm selection |
Adaptations to treatment arm
selection |
Adaptations to treatment arm selection |
It prospectively
planned modifications to the treatment arms included in the clinical
trial based on comparative interim results; modifications could include
adding or terminating arms [5] |
It prospectively planned
modifications to the treatment arms included in the clinical trial based
on comparative interim results; modifications could include adding or
terminating arms [5] |
It prospectively planned modifications to the
treatment arms included in the clinical trial based on comparative
interim results; modifications could include adding or terminating arms
[5] |
Seamless design |
It addresses study objectives within a single trial
that are normally achieved through separate trials in clinical
development [8] |
It addresses study objectives within a single
trial that are normally achieved through separate trials in clinical
development [8] |
It addresses study objectives within a single
trial that are normally achieved through separate trials in clinical
development [8] |
|
|
Enrichment design |
Enrichment design |
Enrichment design |
The
procedure of screening out of a subpopulation from the general
population for an experimental study is called enrichment [9] |
The
procedure of screening out of a subpopulation from the general
population for an experimental study is called enrichment [9] |
The
procedure of screening out of a subpopulation from the general
population for an experimental study is called enrichment
[9] |
Basket study |
Basket study |
Basket study |
A study involves a single
investigational drug or drug combination that is studied across multiple
cancer populations defined by disease stage, histology, number of prior
therapies, genetic or other biomarkers, or demographic characteristics
[10] |
A study involves a single investigational drug or drug
combination that is studied across multiple cancer populations defined
by disease stage, histology, number of prior therapies, genetic or other
biomarkers, or demographic characteristics [10] |
A study involves a
single investigational drug or drug combination that is studied across
multiple cancer populations defined by disease stage, histology, number
of prior therapies, genetic or other biomarkers, or demographic
characteristics [10] |