Structured Protocol Representation for the Cancer Biomedical Informatics Grid: caSPR and caPRI

Vision of the SPR SIG To define a computable protocol representation that supports the entire life-cycle of clinical trials protocol, and develop tools that use these protocol representations. These tools should be standards- based, caBIG compliant and assist users in creating, maintaining, and sharing clinical trials information. The clinical trials protocol representation will serve as a foundation for caBIG modules that support all phases of the clinical trials life cycle, (including protocol authoring) and be developed to meet user needs and requirements. At every stage, we will evaluate and test our work

Goals of SPR SIG Long term goal –Create a structured protocol representation that supports the entire life cycle of clinical trial protocols and serves as an integrative foundation for caBIG compliant applications Short term goals –Create the core data elements to describe a clinical trial protocol (classes) CDISC data model as a starting point Validate model with user input –Demonstrate the use of this SPR in a tool to populate the representation (instances) Protocol registration –Rapid iteration from use cases to early prototype Learn from this process and iterate

Development tasks caSPR –Structured Protocol Representation caPRI –Protocol Representation Instantiator

Initial scope of caSPR From the time that a protocol is entered into an electronic system to the time the protocol is ready to enroll patients –Protocol demographics Title, PI, sponsor, etc Leverage use cases and other data elements that are being developed in other SIGs –Other SIG focus areas (incorporate their information and coordinate as their information becomes available) Limit scope to learn from the process and create early prototype Enter protocol into electronic system Enroll first patient in CT

Entering data using caSPR caSPR will evolve over time –We will start with the core elements, many additional elements will be added throughout the project How do we keep our application up-to-date? How do we iterate rapidly? Can we construct a flexible framework for entering protocol information using caSPR?

Proposed caPRI System Description caPRI Protocol Database caSPR Layout specification Legacy data specification Task context information Business Rules

CaPRI integration into class-level tools caPRI CDE Developer tool caDSR NCI Thesaurus UML models UML XML model Instance Level Class Level

CaPRI integration into system-level tools caPRI CDE Developer tool Instance Level Class Level System Level Stand alone Application Applet within Application Legacy System API Others?

Survey Results and User Requirements Gathering A word about use case construction around core data elements…. –This is hard Use cases are often “one off” from the structured protocol representation –Clinical trial registry (users are searchers—doctors, patients, etc) –Summary 4 (generation of the report is downstream of entering core data elements) –Adverse event reporting (requires elements that identify protocol) The core data elements are the Venn Diagram of all possible use cases –Not feasible for a initial prototype The life cycle is a cycle so a beginning and end are hard to define

Our initial approach –Use CDISC protocol representation elements as an initial set Evaluating CDISC elements and comparing to other representations –CTMS workspace participants –HL7 –Cooperative groups –Validate and clarify processes at adopter sites using use cases, surveys, and experts –Refine these elements in consultation with CDISC, HL7, and experts in caBIG to match needs of the caBIG community

New Idea Generation Research Development Pre-Trial Setup Patient Enrollment Patient Management Reporting & Administration Financial & Billing Data Analysis caSPR

New Idea Generation Research Development Pre-Trial Setup Patient Enrollment Patient Management Reporting & Administration Financial & Billing Data Analysis caSPR Register protocol Pt eligibility determination Pt registration Summary 4 reporting Adverse event reporting CDUS reporting Patient Treatment calendar Budgeting calendar Trial results repository Custom report generation Internal tracking (IRB,PRC, fiscal, etc) CT registry to disseminate information Statistical analysis Custom case report forms Pt laboratory information Data mining Financial and billing information PI protocol authoring

New Idea Generation Research Development Pre-Trial Setup Patient Enrollment Patient Management Reporting & Administration Financial & Billing Data Analysis caSPR: Year 1 Register protocol Pt eligibility determination Pt registration Summary 4 reporting Adverse event reporting CDUS reporting Patient Treatment calendar Budgeting calendar Trial results repository Custom report generation Internal tracking (IRB,PRC, fiscal, etc) CT registry to disseminate information Statistical analysis Custom case report forms Pt laboratory information Data mining Financial and billing information PI protocol authoring

New Idea Generation Research Development Pre-Trial Setup Patient Enrollment Patient Management Reporting & Administration Financial & Billing Data Analysis caSPR:Year 3 Register protocol Pt eligibility determination Pt registration Summary 4 reporting Adverse event reporting CDUS reporting Patient Treatment calendar Budgeting calendar Trial results repository Custom report generation Internal tracking (IRB,PRC, fiscal, etc) CT registry to disseminate information Statistical analysis Custom case report forms Pt laboratory information Data mining Financial and billing information PI protocol authoring

New Idea Generation Research Development Pre-Trial Setup Patient Enrollment Patient Management Reporting & Administration Financial & Billing Data Analysis caSPR: Year 5 Register protocol Pt eligibility determination Pt registration Summary 4 reporting Adverse event reporting CDUS reporting Patient Treatment calendar Budgeting calendar Trial results repository Custom report generation Internal tracking (IRB,PRC, fiscal, etc) CT registry to disseminate information Statistical analysis Custom case report forms Pt laboratory information Data mining Financial and billing information PI protocol authoring

New Idea Generation Research Development Pre-Trial Setup Patient Enrollment Patient Management Reporting & Administration Financial & Billing Data Analysis caSPR: Other SIG contributions Register protocol Pt eligibility determination Pt registration Summary 4 reporting Adverse event reporting CDUS reporting Patient Treatment calendar Budgeting calendar Trial results repository Custom report generation Internal tracking (IRB,PRC, fiscal, etc) CT registry to disseminate information Statistical analysis Custom case report forms Pt laboratory information Data mining Financial and billing information PI protocol authoring