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]