# Presentation: 638450

## Pilot Project : caMATCHMatching Patients to Clinical Trials

- A Contribution to Strategic Research and Standards Development for
- Clinical Trials Matching Tools

## 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

## 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

**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

## 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

**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

## What is bct.org?

## 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

- 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

## 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

- 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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**Notes:**
Brenda: I couldn’t get a message that opened up with a trial site opened...so we will just have to talk about consenting to release record and that trial site is asked to get back to patient within 1 week.

Next slide switch to investigator

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**Notes:**
Investigators will be able to go to My Trials Page and click on protocol number to view trial

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## 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

## Matching Service

- Patient Health Record

- Protocol

- Structured
- Eligibility Criteria
- (Matching Rules)

**Match/No Match**

**Notes:**
We have the Patient Health Record and Patient recruitment Protocol in the electronic form 
Matching service reads the patient recruitment protocol and compares it to the Patient Health Record based on the Eligibility Criteria or Matching Rules. 
Matching service reports if the patient qualifies for a protocol or not

## Architecture Roadmap

**Pilot**

**caBig Bronze**

**CaBig Silver**

**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

## 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**

## 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.

## 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.

## 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.

## 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.

## 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?

## 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