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The purpose of Trial Design datasets is to represent a brief, clear description of the overall plan and design of a trial or study. Trial Design datasets
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contain study-level, rather than subject-level
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, information. Implementation of Trial Design datasets requires the explicit statement of certain decision rules that may not be addressed or may not be as explicit in the textual description of a study plan such as an approved study protocol
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Trial Design Concepts
A nonclinical study is a scientific experiment, typically involving animal subjects, which is intended to address certain scientific questions that are the objectives of the study.
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Branch:
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or
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Element:
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An Element is a basic building block in the study design. All Elements are related to the administration of planned interventions, which may involve treatment or no treatment, during a period of time. Elements for which the planned intervention does not involve treatment would include screening, washout, and recovery.
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Epoch:
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study
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Treatments:
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The word "treatment" may be used in connection with Epochs or Elements, but has somewhat different meanings in each context:
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Trial Arm: | A Trial Arm is a planned path through the study based upon a planned sequence of Elements. This path covers the entire time of the study. Each sponsor-defined protocol group may contain subjects from several Arms, one Arm, or part of an Arm. Each subject is assigned to one and only one planned Arm. |
Trial Design: | The design of a study is a plan outlining the activities subjects will experience and what data will be collected during the course of the study in order to address the study's objectives. |
Trial Group: | A group describes the sponsor-defined protocol structure commonly used in nonclinical studies, where study subjects are allocated to study groups within the study protocol. These groups may be defined for a variety of experimental purposes. Groups are frequently defined to separate subjects receiving different treatments, but there may be other considerations involved in the design of any particular study. For purposes of SEND, a Trial Group is a collection of subjects which have been designated with the same sponsor-defined protocol group code. A Trial Group consists of one or more Trial Sets. |
Trial Set: | A Trial Set is a collection of subjects that have a common set of parameters defined in the protocol, where those parameters include experimental parameters (such as diet restriction), treatment parameters, and/or sponsor-defined attributes (such as control group designation). There should be no planned parameters of interest that could further subdivide a Trial Set. Each subject must be assigned to one and only one Trial Set. Each Trial Set should be assigned to a single Group. Each Set should be assigned to a single Trial Arm. |
Trial Summary: | As part of the Trial Design datasets, Trial Summary provides important or key study-level information. |
SDTM
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plan
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- Because epochs cut across arms, an epoch treatment is at a high level that does not specify anything that differs between arms. For example, in a 3-period crossover study of 3 doses of drug X, each treatment epoch is associated with drug X, but not with a specific dose.
- A study cell treatment is specific to a particular arm. For example, a parallel trial might have study cell treatments placebo and drug X, without any additional detail (e.g., dose, frequency, route of administration) being specified. A study cell treatment is at a relatively high level, the level at which treatments might be planned in an early conceptual draft of the trial, or in the title or objectives of the trial.
- An element treatment may be fairly detailed. For example, for an element representing a cycle of chemotherapy, element treatment might specify 5 daily 100 mg doses of drug X.
The distinctions between these levels are not rigid, and depend on the objectives of the trial. For example, route is generally a detail of dosing, but in a bioequivalence trial comparing IV and oral administration of drug X, route is clearly part of study cell treatment.
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