1. caMATCH Pilot Project1 Pilot Project : caMATCH Matching Patients to Clinical Trials A Contribution to Strategic Research and Standards Development for Clinical Trials Matching Tools

2. caMATCH Pilot Project2 CaMATCH Background BreastCancerTrials.org (BCT.org), is a patient centric clinical trial matching tool Conceived of by patient advocates, a prototype was developed collaboratively with UCSF NCI Center for Bioinformatics (NCICB), in a collaborative effort with the patient advocates and UCSF further developed the prototype to build a robust back end and to provide matching algorithms against a structured eligibility format NCI’s Office of Communications (OC), worked as members of the core team and actively input eligibility criteria from PDQ trials in the bay area

3. caMATCH Pilot Project3 caMATCH Concept Match patient provided medical history to clinical trial screening criteria –More effective screening of potential patients for investigators through detailed, patient provided health information and patient initiated contacts –Patient health history is documented through a series of forms that are detailed about their diagnosis and treatment history –Structured, computable eligibility screening criteria are completed by core team members and reviewed/approved by investigators –System matches the data from both sources, providing a more detailed match of patient to trial

4. caMATCH Pilot Project4 caMATCH Concept Facilitate patient access to eligible clinical trials –Pilot is limited to the San Francisco Bay Area –Accessible and open to the general public –Designed for patient use with patient tested interface –Through series of Learn More content, patient is guided through documenting detailed information –Personal one-on-one assistance available if needed –Patient encouraged to involve their community oncologist in gathering the information Preserve privacy of all parties –Through a series of consents, patients control the exchange of information with potential investigators

5. caMATCH Pilot Project5 What is bct.org? Breast Cancer Patient/Caregiver Breast Cancer Investigator IRB-Approved Study Information Eligibility Criteria Educational Information Update Info Request Matched Trial Info PI Contact Info Database Patient Info Trial Info Match Rules Clinical Trial Search and Recruitment Processing Currency of Records? Timer Consent Demographics Medical Record Contact Information Patient Info by Consent Update Info Request Paper Forms?

6. caMATCH Pilot Project6 BCT Pilot San Francisco Bay area for trials: 50 – 100 Trials Goal is to recruit ALL Breast Cancer trials for San Francisco Bay Area –Incent patients with comprehensive, accurate information –Incent investigators with more patient participation Start Date for Pilot: March 2005 No restrictions on patient participation No regulator roles involved –System development and maintenance support from NCICB –Trial information gathering support from NCI Office of Communications Local patient and system user support from –UCSF Carol Franc Buck Breast Care Center –The Center of Excellence for Breast Cancer Care

7. caMATCH Pilot Project7 CaMATCH Scenario Investigators approve screening criteria for their trial entered by PDQ staff Patient creates a Personal Health Record (PHR): –Cancer diagnosis and current clinical status –Detailed information about treatment Patients request a match of their record against eligibility screening criteria System matches both sources of data and shows results Patient initiates the contact for the matched trials Investigator follows up with screening

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32. caMATCH Pilot Project32 Current caMatch Architecture Proprietary structured protocol and patient representation Manual Eligibility Criteria Management Predetermined patterns of eligibility criteria matching based on breast cancer trials Access to data via Browser interface Investigators Logical Data Model - Reusable Services - Component Library caMatch Infrastructure J2EE, Struts, Hibernate, JDBC, XML Database Patients Site Administration caMatch Application Components Patient Management Trial Management Eligibility Criteria Management Matching Service Browser

33. caMATCH Pilot Project33 Matching Service Patient Health Record Protocol Matching Service Structured Eligibility Criteria (Matching Rules) Match/No Match

34. caMATCH Pilot Project34 Architecture Roadmap Pilot caBig Bronze CaBig Silver Architecture Roadmap Proprietary Custom structured protocol and patient Non standard vocabulary Enhanced Matching 2 Step matching process Extensions to patterns of eligibility criteria for other cancer domains Eligibility Criteria Authoring Tool to compose eligibility criteria Eligibility Criteria Versioning Enhanced Data Collection Vocabulary driven data entry (CDE’s from caDSR) Reuse Built on common platform (J2EE) Open Source Software (Struts, Hibernate, XML) Services Expose a web service to receive protocols from external systems Expose a web service to match an Patient’s EHR HL7 Standards Receive and match Patient Records received as HL7 EHR’s Collaborate with the HL7 structured protocol efforts

35. caMATCH Pilot Project35 Target caMatch Architecture Investigators caMatch Infrastructure J2EE, Struts, Hibernate, JDBC, XML Application Database Patients Site Administration caMatch Application Components Patient Management Trial Management Eligibility Criteria Management Matching Service Browser PDQ Pharma Companies Other Protocol Data sources HL7 Structured Protocol Record Presentation Layer JSP / HTML/ Javascript Exposed API Web Services \ WSDL caDSR Standardized representation for common data elements Patient Providers HL7 EHR Match Requests Matching and Eligibility Criteria Enhancements

36. caMATCH Pilot Project36 Unique caMATCH Traits Accuracy and Quality –Focus on one disease allows for data collection and data matching rules that are customized to breast cancer. –Algorithms generate matches that are highly specific and tailored to individual patients. –Currency of records is monitored: patients are required to update their records twice annually and investigators once annually. –Match results are updated when data from either source changes. –Matching is based on specific criteria and patient observations, not a text search or a general classification of the trials Investigator Anonymity –Investigators do not openly post their trials. –Only patients who match a trial receive investigator contact information.

37. caMATCH Pilot Project37 Unique caMATCH Traits Usability –Patients input their history once, after which it is saved and automatically compared to newly registered trials on an ongoing basis. –User-friendly forms capture structured data in pull-down menus, check boxes, and radio buttons. Usability lab tested interface! –The system is a patient resource for organizing and storing personal health information that can be downloaded and printed. –The site features educational information about clinical trials and resources for helping patients make decisions about participation. Accessibility –caMATCH has provisions for patients who do not have access to computers by allowing for alternative contacts or registration on print forms by mail.

38. caMATCH Pilot Project38 caMATCH Pilot Operational Goals Enable patients to store personal health data. Provide a user-friendly interface for data entry, matching, and access to additional supportive information and resources. Ensure security and confidentiality for the storage and exchange of personal health data, with HIPAA compliance as a floor. Execute valid matches of individual patients to appropriate trials. Enable clinical trials researchers to receive standards- based patient profiles for assessment of eligibility.

39. caMATCH Pilot Project39 caMATCH Strategic Goals Improve patient and provider access to information about clinical trials: –Single source of information about clinical trials. –Easily understandable information specific to patient. Enhance collaboration between researchers and patients. Reduced clinical research costs due to: –More effective patient recruiting efforts –Improve investigator access to patients for clinical trials. –Faster and less costly research due to reduced duplication of effort. –Reduced inconsistencies in meaning of information. –Reduces redundant systems (hardware/software) at multiple sites. –Leverage information for research applications. Maximize the utility of the caBIG infrastructure.

40. caMATCH Pilot Project40 caMATCH Strategic Research Can interactive online tools improve clinical trials recruitment? What are the human factor issues related to interactive online tools? What are the technical issues related to successfully matching patients to appropriate trials? What are patients’ attitudes toward online personal health management tools? What are researchers’ attitudes toward patient-controlled online recruitment tools? What special issues are involved in working with underserved populations to develop, implement and promote online recruitment tools? What is needed to develop standards-based approaches to patient data entry and eligibility criteria?

41. caMATCH Pilot Project41 caMATCH: Evaluating Standards- based Approaches to Online Clinical Trial Matching Work with standards development organizations (e.g. hl7, CDISC, OMG) Work with providers of online matching services (commercial and not-for-profit) Work with other stakeholders, including research, policy, and patient advocacy groups