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

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

2. Vision of the SPR SIG • To define a computable protocol representation that supports the entire life-cycle of clinical trials protocol, and developtools 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

3. 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 • Rapiditeration from use cases to early prototype • Learn from this process and iterate

4. Development tasks • caSPR –Structured Protocol Representation • caPRI –Protocol Representation Instantiator

5. 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

6. 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?

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

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

10. 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

11. 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

12. caSPR ResearchDevelopment Pre-Trial Setup PatientEnrollment New IdeaGeneration PatientManagement DataAnalysis Financial& Billing Reporting & Administration

13. caSPR ResearchDevelopment Pre-Trial Setup PatientEnrollment New IdeaGeneration PatientManagement DataAnalysis Financial& Billing Reporting & Administration 1 Register protocol Internal tracking (IRB,PRC, fiscal, etc) 2 PI protocol authoring 13 CT registry to disseminate information 3 Custom report generation 12 Data mining 11 Pt eligibility determination 4 10 Trial results repository Pt registration 5 Statistical analysis 9 Patient Treatment calendar 6 Financial and billing information Custom case report forms 7 8 Summary 4 reporting Budgeting calendar CDUS reporting Pt laboratory information Adverse event reporting

14. caSPR: Year 1 ResearchDevelopment Pre-Trial Setup PatientEnrollment New IdeaGeneration PatientManagement DataAnalysis Financial& Billing Reporting & Administration 1 Register protocol Internal tracking (IRB,PRC, fiscal, etc) 2 PI protocol authoring 13 CT registry to disseminate information 3 Custom report generation 12 Data mining 11 Pt eligibility determination 4 10 Trial results repository Pt registration 5 Statistical analysis 9 Patient Treatment calendar 6 Financial and billing information Custom case report forms 7 8 Summary 4 reporting Budgeting calendar CDUS reporting Pt laboratory information Adverse event reporting

15. caSPR:Year 3 ResearchDevelopment Pre-Trial Setup PatientEnrollment New IdeaGeneration PatientManagement DataAnalysis Financial& Billing Reporting & Administration 1 Register protocol Internal tracking (IRB,PRC, fiscal, etc) 2 PI protocol authoring 13 CT registry to disseminate information 3 Custom report generation 12 Data mining 11 Pt eligibility determination 4 10 Trial results repository Pt registration 5 Statistical analysis 9 Patient Treatment calendar 6 Financial and billing information Custom case report forms 7 8 Summary 4 reporting Budgeting calendar CDUS reporting Pt laboratory information Adverse event reporting

16. caSPR: Year 5 ResearchDevelopment Pre-Trial Setup PatientEnrollment New IdeaGeneration PatientManagement DataAnalysis Financial& Billing Reporting & Administration 1 Register protocol Internal tracking (IRB,PRC, fiscal, etc) 2 PI protocol authoring 13 CT registry to disseminate information 3 Custom report generation 12 Data mining 11 Pt eligibility determination 4 10 Trial results repository Pt registration 5 Statistical analysis 9 Patient Treatment calendar 6 Financial and billing information Custom case report forms 7 8 Summary 4 reporting Budgeting calendar CDUS reporting Pt laboratory information Adverse event reporting

17. caSPR: Other SIG contributions ResearchDevelopment Pre-Trial Setup PatientEnrollment New IdeaGeneration PatientManagement DataAnalysis Financial& Billing Reporting & Administration 1 Register protocol Internal tracking (IRB,PRC, fiscal, etc) 2 PI protocol authoring 13 CT registry to disseminate information 3 Custom report generation 12 Data mining 11 Pt eligibility determination 4 10 Trial results repository Pt registration 5 Statistical analysis 9 Patient Treatment calendar 6 Financial and billing information Custom case report forms 7 8 Summary 4 reporting Budgeting calendar CDUS reporting Pt laboratory information Adverse event reporting