CaMATCH Pilot Project1 Pilot Project : caMATCH Matching Patients to Clinical Trials A Contribution...

caMATCH Pilot Project 1

Pilot Project : caMATCHMatching 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


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


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


What is bct.org?

Breast CancerPatient/Caregiver

Breast CancerInvestigator

IRB-ApprovedStudy InformationEligibility Criteria

Educational InformationUpdate Info Request

Matched Trial InfoPI Contact Info

Database

Patient Info

Trial Info

Match Rules

Clinical TrialSearch and Recruitment Processing

Currency of Records?

Timer

ConsentDemographicsMedical RecordContact Information

Patient Info by ConsentUpdate Info Request

PaperForms?


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


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


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 LibrarycaMatch InfrastructureJ2EE, 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

Matching Service

StructuredEligibility Criteria

(Matching Rules)

Match/No Match


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


Target caMatch ArchitectureInvestigators

caMatch InfrastructureJ2EE, 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

PatientProviders

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

CaMATCH Pilot Project1 Pilot Project : caMATCH Matching Patients to Clinical Trials A Contribution...

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