Framework for modeling a clinical trial study using a cross-over treatment design

A non-transitory computer readable storage medium configured to store program instructions that, when executed on a processor, are configured to cause the processor to:

• generate a data model object and storing the data model object in a memory, wherein the data model object comprising
• a treatment entity identifying a plurality of treatments for a clinical trial study, wherein
• each of the plurality of treatments is based on a first subset of the operational parameters;
• a sequence entity identifying a plurality of sequences for the clinical trial study, wherein
• each of the plurality of sequences is based on a second subset of the operational parameters, wherein the second subset comprises a washout period parameter representing a washout period associated with each of the sequences, and
• each sequence of the plurality of sequences comprises a combination of ones of the plurality of treatments;
• assign, by the processor using the data model object, a plurality of subject groups to each of the plurality of sequences, wherein
• one subject group of the plurality of subject groups is respectively assigned to one sequence of the plurality of sequences,
• the one sequence is scheduled to be administered to subjects of the one subject group during the clinical trial study, and
• the one sequence is determined, at least in part, based on the washout period parameter associated with the one sequence;
• generate in a data structure, by the processor, a subject visit schedule for the plurality of sequences and the assigned subject groups, wherein the subject visit schedule indicates a plurality of subject visits scheduled for the one subject group assigned to the one sequence;
• and
• transmit, by the processor via network communication, the data structure including the subject visit schedule to a user interface to display the subject visit schedule on a device to assist a user to schedule the plurality of treatments according to the subject visit schedule.

An apparatus comprising:

• a computer including at least a processor for executing instructions;
• and
• a memory coupled to the processor and configured with stored instructions executable by the processor to:
• generate a data model object and storing the data model object in the memory, wherein the data model object comprising
• a treatment entity identifying a plurality of treatments for a clinical trial study, wherein each of the plurality of treatments is based on a first subset of the operational parameters;
• a sequence entity identifying a plurality of sequences for the clinical trial study, wherein
• each of the plurality of sequences is based on a second subset of the operational parameters, wherein the second subset comprises a washout period parameter representing a washout period associated with each of the sequences, and
• each sequence of the plurality of sequences comprises a combination of ones of the plurality of treatments;
• use the data model to assign a plurality of subject groups to each of the plurality of sequences, wherein
• one subject group of the plurality of subject groups is respectively assigned to one sequence of the plurality of sequences,
• the one sequence is scheduled to be administered to subjects of the one subject group during the clinical trial study, and
• the one sequence is determined, at least in part, based on the washout period parameter associated with the one sequence;
• generate in a data structure, by the processor, a subject visit schedule for the plurality of sequences and the assigned subject groups, wherein the subject visit schedule indicates a plurality of subject visits scheduled for the one subject group assigned to the one sequence;
• and
• transmit, by the processor via network communication, the data structure including the subject visit schedule to a user interface to display the subject visit schedule on a device to assist a user to schedule the plurality of treatments according to the subject visit schedule.