Design assistance for clinical trial protocols

Abstract

Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements in the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. After all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.

1 . A method of developing a clinical trial protocol for a clinical trial, the method comprising:
 selecting, using a computing device, at least one task from a historical database that stores a plurality of tasks associated with previous clinical trial protocols;   defining, using the computing device, an event schedule that comprises at least one event in connection with performance of the at least one task; and   associating, using the computing device, in the clinical trial protocol the at least one task to the at least one event of the event schedule.   
     
     
         2 . The method of  claim 1 , wherein selecting the at least one task comprises:
 querying the historical database using a filtering criteria;   retrieving a subset of tasks from the plurality of individual tasks based on the filtering criteria, the subset comprising one or more tasks; and   selecting the at least one task from the subset of tasks retrieved.   
     
     
         3 . The method of  claim 2 , wherein the filtering criteria comprise at least one of a clinical indication, a trial phase and a past time window associated with the previous clinical trial protocols. 
     
     
         4 . The method of  claim 3 , wherein the filtering criteria comprise the clinical indication and a task in the subset of tasks retrieved is for a clinical trial protocol associated with a past protocol date within the past time window. 
     
     
         5 . The method of  claim 3 , wherein the filtering criteria comprise the clinical indication and a task in the subset of tasks has at least a predetermined strength of association to previous clinical trial protocols for the clinical indication. 
     
     
         6 . The method of  claim 3 , wherein, the filtering criteria comprise the trial phase and a task in the subset of tasks has at least a predetermined strength of association to previous clinical trial protocols for the trial phase. 
     
     
         7 . The method of  claim 2 , wherein the filtering criteria comprises text-based search criteria and a task in the subset of tasks retrieved is for a clinical trial protocol that comprises the text-based search criteria. 
     
     
         8 . The method of  claim 1 , wherein the method further comprises generating a structured protocol modeling database in connection with the clinical trial protocol. 
     
     
         9 . The method according to  claim 1 , wherein the method further comprises scheduling a task of the at least one task for performance in at least one event of the clinical trial protocol. 
     
     
         10 . The method according to  claim 1 , wherein the method further comprises entering a purpose for performing the task scheduled for performance in the at least one event. 
     
     
         11 . The method according to  claim 10 , wherein entering the purpose comprises selecting the purpose from a list of offered purposes. 
     
     
         12 . The method according to  claim 10 , wherein the purpose is one of efficacy, screening, regulatory, safety, and outcome of the clinical trial. 
     
     
         13 . The method according to  claim 10 , wherein entering the purpose comprises linking the purpose with a task-event linkage that links a task and an event. 
     
     
         14 . The method according to  claim 2 , wherein retrieving the subset of tasks includes retrieving a cost estimate for the tasks in the subset. 
     
     
         15 . The method according to  claim 14 , wherein the cost estimate is retrieved in dependence upon a historical database that includes task costs. 
     
     
         16 . The method according to  claim 14 , wherein the cost estimate is per purpose. 
     
     
         17 . The method according to  claim 1 , wherein the method further comprises:
 generating a table including the at least one event along a first dimension of the table and the at least one task along a second dimension of the table;   marking at least one task-event linkage in the table at which the at least one task is linked to the at least one event.   
     
     
         18 . The method according to  claim 17 , wherein the method further comprises generating a schedule-of-activities table in dependence upon the at least one task-event linkage. 
     
     
         19 . The method according to  claim 18 , wherein the method further comprises entering a purpose associated with the at least one task-event linkage into the schedule-of-activities table. 
     
     
         20 . The method according to  claim 17 , wherein the method further comprises providing, in dependence upon the at least one task-event linkage, a total per-patient cost estimate for the clinical trial conducted according to the clinical trial protocol or an event from the at least one event. 
     
     
         21 . The method according to  claim 1 , wherein the method further comprises entering an endpoint in connection with a patient in the clinical trial. 
     
     
         22 . The method according to  claim 21 , wherein the method further comprises associating the endpoint with at least one measurement in connection with the least one task associated to the at least one event. 
     
     
         23 . The method according to  claim 22 , wherein the endpoint is of a type primary efficacy, secondary efficacy, tertiary efficacy, safety, or pharmaco-economic. 
     
     
         24 . The method according to  claim 21 , wherein entering the endpoint comprises selecting the endpoint from a list of offered endpoints. 
     
     
         25 . The method according to  claim 21 , wherein the method further comprises associating the endpoint with an objective, the objective associated with the clinical trial. 
     
     
         26 . The method according to  claim 25 , wherein the objective is one of primary objective, secondary objective, and tertiary objective. 
     
     
         27 . A system to develop a clinical trial protocol for a clinical trial, the system comprising:
 a computing device comprising a processor and a memory storing instructions that, when executed by the processor, cause the processor to perform operations comprising:
 selecting at least one task from a historical database that stores a plurality of tasks associated with previous clinical trial protocols; 
 defining an event schedule that comprises at least one event in connection with performance of the at least one task; and 
 associating in the clinical trial protocol the at least one task to the at least one event of the event schedule. 
   
     
     
         28 . The system of  claim 27 , wherein the operations of selecting the at least one task comprise:
 querying the historical database using a filtering criteria;   retrieving a subset of tasks from the plurality of individual tasks based on the filtering criteria, the subset comprising one or more tasks; and   selecting the at least one task from the subset of tasks retrieved.   
     
     
         29 . The system of  claim 28 , wherein the filtering criteria comprise at least one of a clinical indication, a trial phase and a past time window associated with the previous clinical trial protocols. 
     
     
         30 . The system of  claim 29 , wherein the filtering criteria comprise the clinical indication and a task in the subset of tasks retrieved is for a clinical trial protocol associated with a past protocol date within the past time window. 
     
     
         31 . The system of  claim 29 , wherein the filtering criteria comprise the clinical indication and a task in the subset of tasks has at least a predetermined strength of association to previous clinical trial protocols for the clinical indication. 
     
     
         32 . The system of  claim 29 , wherein, the filtering criteria comprise the trial phase and a task in the subset of tasks has at least a predetermined strength of association to previous clinical trial protocols for the trial phase. 
     
     
         33 . The system of  claim 28 , wherein the filtering criteria comprises text-based search criteria and a task in the subset of tasks retrieved is for a clinical trial protocol that comprises the text-based search criteria. 
     
     
         34 . The system of  claim 27 , wherein the operations further comprise generating a structured protocol modeling database in connection with the clinical trial protocol. 
     
     
         35 . The system according to  claim 27 , wherein the operations further comprise scheduling a task of the at least one task for performance in at least one event of the clinical trial protocol. 
     
     
         36 . The system according to  claim 27 , wherein the operations further comprise entering a purpose for performing the task scheduled for performance in the at least one event. 
     
     
         37 . The system according to  claim 36 , wherein the operations of entering the purpose comprise selecting the purpose from a list of offered purposes. 
     
     
         38 . The system according to  claim 36 , wherein the purpose is one of efficacy, screening, regulatory, safety, and outcome of the clinical trial. 
     
     
         39 . The system according to  claim 36 , wherein the operations of entering the purpose comprise linking the purpose with a task-event linkage that links a task and an event. 
     
     
         40 . The system according to  claim 28 , wherein the operations of retrieving the subset of tasks comprise retrieving a cost estimate for the tasks in the subset. 
     
     
         41 . The system according to  claim 40 , wherein the cost estimate is retrieved in dependence upon a historical database that includes task costs. 
     
     
         42 . The system according to  claim 40 , wherein the cost estimate is per purpose. 
     
     
         43 . The system according to  claim 27 , wherein the operations further comprise:
 generating a table including the at least one event along a first dimension of the table and the at least one task along a second dimension of the table; and   marking at least one task-event linkage in the table at which the at least one task is linked to the at least one event.   
     
     
         44 . The system according to  claim 43 , wherein the operations further comprise generating a schedule-of-activities table in dependence upon the at least one task-event linkage. 
     
     
         45 . The system according to  claim 44 , wherein the operations further comprise entering a purpose associated with the at least one task-event linkage into the schedule-of-activities table. 
     
     
         46 . The system according to  claim 43 , wherein the operations further comprise providing, in dependence upon the at least one task-event linkage, a total per-patient cost estimate for the clinical trial conducted according to the clinical trial protocol or an event from the at least one event. 
     
     
         47 . The system according to  claim 27 , wherein the operations further comprise entering an endpoint in connection with a patient in the clinical trial. 
     
     
         48 . The system according to  claim 47 , wherein the operations further comprise associating the endpoint with at least one measurement in connection with the least one task associated to the at least one event. 
     
     
         49 . The system according to  claim 48 , wherein the endpoint is of a type primary efficacy, secondary efficacy, tertiary efficacy, safety, or pharmaco-economic. 
     
     
         50 . The system according to  claim 47 , wherein the operations of entering the endpoint comprise selecting the endpoint from a list of offered endpoints. 
     
     
         51 . The system according to  claim 47 , wherein the operations further comprise associating the endpoint with an objective, the objective associated with the clinical trial. 
     
     
         52 . The system according to  claim 51 , wherein the objective is one of primary objective, secondary objective, and tertiary objective.