What is a group sequential design?

Group sequential design is an example of a statistical approach in clinical trial design. It means that the sample size of the trial is not fixed in advance, and data is sequentially evaluated as it is collected. This is known as interim analysis, and might be carried out at several points in time.

What is group sequential testing?

Group sequential trials are used in clinical trials. A group sequential design is a type of adaptive design where the number of patients isn’t set in advance. Patients are divided into an equal number of groups and data is analyzed at pre-determined points in the trial.

What are sequential methods?

The sequential method is used to allocate the cost of service departments to other departments within an organization. Under this approach, the cost of each service department is allocated one department at a time. Because this method involves a one-way cost allocation, it is not entirely theoretically correct.

What is futility boundary?

A futility boundary (futility stopping boundary, rarely futility limit) is a statistical decision boundary used in sequential testing such as an AGILE A/B test. It is built in such a way that it maintains the type II error probability (beta β) larger than a specified level, on average.

What is parallel group design?

A parallel group design is an experimental study design in which each subject is randomized to one of two or more distinct treatment/intervention groups. Those who are assigned to the same treatment are referred to as a treatment group.

Bayesian designs According to FDA guidelines, an adaptive Bayesian clinical trial can involve: Interim looks to stop or to adjust patient accrual. Interim looks to assess stopping the trial early either for success, futility or harm. Reversing the hypothesis of non-inferiority to superiority or vice versa.

What is sequential A B testing?

Sequential testing is the practice of making decision during an A/B test by sequentially monitoring the data as it accrues. Sequential testing employs optional stopping rules (error-spending functions) that guarantee the overall type I error rate of the procedure.

What is sequential experiment?

A series of tests, referred to as sequential experimentation, is a recommended practice that can be best planned, at least in terms of a general strategy, prior to test. The information gained at each stage of experimentation is invaluable in considering how to continue the investigation.

How do you use sequential method?

In the sequential method, a company allocates service costs one department at a time. The company allocates these costs to other service departments and to production departments. Once accountants allocate a service department’s costs, the department doesn’t receive any costs from other service departments.

What is a sequential study design?

Sequential research designs include elements of both longitudinal and cross-sectional research designs. Similar to longitudinal designs, sequential research features participants who are followed over time; similar to cross-sectional designs, sequential research includes participants of different ages.

What is futility index?

One method of sequential analysis that has intuitive appeal for many medical investigators is based on the calculation of what we have termed the futility index, defined as the conditional probability that the trial will fail to demonstrate the superiority of the innovation given the results already observed [24,25].

What is a futility test?

The term ‘futility’ is used to refer to the inability of a clinical trial to achieve its objectives. In particular, stopping a clinical trial when the interim results suggest that it is unlikely to achieve statistical significance can save resources that could be used on more promising research.

What do you need to know about group sequential design?

A group sequential design provides detailed specifications for a group sequential trial. In addition to the usual specifications, it provides the total number of stages (the number of interim stages plus a final stage) and a stopping criterion to either reject or accept the null hypothesis at each interim stage.

What do you need to know about SAS sequential design?

In addition to the usual specifications, it provides the total number of stages (the number of interim stages plus a final stage) and a stopping criterion to either reject or accept the null hypothesis at each interim stage. It also provides critical values and the sample size at each stage for the trial.

When to stop for futility in group sequential designs?

In the context of group sequential designs, it can generally be differentiated between binding and non-binding stopping for futility rules, compare also Bretz et al [ 26 ]. ‘Binding’ means that stopping for futility at the interim analysis is obligatory whenever the futility criteria are met.

What is the purpose of group sequential testing?

A group-sequential testing stage is a point in the accumulation of the data where an interim analysis occurs, either by design or by necessity. At each stage, a test statistic is computed with all the accumulated data, and it is determined whether a boundary (efficacy or futility) is crossed.

What is a group sequential design? Group sequential design is an example of a statistical approach in clinical trial design. It means that the sample size of the trial is not fixed in advance, and data is sequentially evaluated as it is collected. This is known as interim analysis, and might be carried out at…