informatics in breast cancer research i-spy 2 trial & transcend
TRANSCRIPT
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Informatics in Breast Cancer ResearchI-SPY 2 TRIAL & TRANSCEND
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I-SPY 2 TRIAL
• Screen phase 2 agents in combination with standard chemotherapy in neoadjuvant setting– Endpoint is pCR– Intermediate endpoint is MRI Volume
• Accelerate process of identifying drugs that are effective for specific breast cancer subtypes– Integration of biomarkers
• Reduce the cost, time, and number of patients needed to get effective drugs to market– “threshold” is 85% predicted likelihood of success in a 300-patient
phase 3 trial for drug-biomarker pair
Design goals of I-SPY 2
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I-SPY 2 TRIAL
I-SPY 2 Adaptive Trial Design
* HER2 positive participants will also receive Trastuzumab. An investigational agent may be used instead of Trastuzumab.
ON
STUDY
MRIBiopsy
Blood DrawMUGA/ECHO
CT/PET
Screening
RANDOMIZE
Consent #2Treatment Consent
Consent #1
S
U
R
G
E
R
Y
Tissue
Paclitaxel* +Investigational Agent C AC
MRIBiopsy
Blood Draw
MRIBlood Draw
MRIBlood Draw
Paclitaxel* +Investigational Agent D AC
Paclitaxel* +Investigational Agent E AC
Paclitaxel* +Investigational Agent B AC
Paclitaxel* +Investigational Agent A AC
Paclitaxel*
AC
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I-SPY 2 TRIAL
I-SPY 2 Adaptive Trial Design
ON
STUDY
MRIBiopsy
Blood DrawMUGA/ECHO
CT/PET
Screening
RANDOMIZE
Consent #2Treatment Consent
Consent #1
S
U
R
G
E
R
Y
Tissue
Paclitaxel* +Investigational Agent C AC
MRIBiopsy
Blood Draw
MRIBlood Draw
MRIBlood Draw
* HER2 positive participants will also receive Trastuzumab. An investigational agent may be used instead of Trastuzumab.
Paclitaxel* +Investigational Agent D AC
Paclitaxel* +Investigational Agent E AC
Paclitaxel* +Investigational Agent B AC
Paclitaxel* +Investigational Agent A AC
Paclitaxel*
AC
Paclitaxel* +Investigational Agent FG AC
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I-SPY 2 TRIALInformatics Needs for Adaptive Clinical Trials – I-SPY 2
• Manage information across multiple sites• Data gathering must be closely monitored as the trial
depends on rapid eligibility determination and therapeutic intervention - do not want to delay therapy
• Randomization as a web service (automated - but with review)
• Combining evaluation of drugs and biomarkers together– Biomarker data is of various types (arrays, imaging volume,
numeric scales, etc..)
• Scientists need access to data early and in an integrated fashion (one stop shopping)
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I-SPY 2 TRIAL
What is TRANSCEND?
TRANslational Informatics System to Coordinate Emerging Biomarkers,
Novel Agents, and Clinical Data
An IT Bundle to Support Adaptive Trials with Novel Agents and Emerging Biomarkers
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I-SPY 2 TRIAL
TRANSCEND Objectives
• Develop an information management infrastructure to support adaptive clinical trials like I-SPY 2
• Provide real-time data verification for more efficient analysis of trial data
• Provide a demonstration of caBIG infrastructure in use in a large multi-center trial
• Demonstrate integration of a clinical system (electronic health record system) with a clinical research infrastructure
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I-SPY 2 TRIAL
TRANSCEND - Systems OverviewTolven eCHR
Data Coordinating
Center
Study SitesCase Report
Forms
Agendia
Integration Hub
(caXchange)
caTissue Suite caIntegrator
caAers caArray
Research Labs
MD Anderson
Randomization Engine
Automated interface
Manual interface
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I-SPY 2 TRIAL
TRANSCEND – eCHR Data Collection
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I-SPY 2 TRIAL
• Electronic copy of source documentation with each CRF
• Easy to complete case report forms with smart logic
TRANSCEND – eCHR Data Collection
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I-SPY 2 TRIAL
TRANSCEND – eCHR Data Verification • Real-time data review and
verification
• Instant submission of CRF with source documentation to Data Coordination Center
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I-SPY 2 TRIAL
TRANSCEND – eCHR Data Collection • Email alerts to when a CRF is
ready for review & verification
• Email alerts when a CRF is rejected by the DCC
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I-SPY 2 TRIAL
TRANSCEND - Randomization
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I-SPY 2 TRIAL
Future Direction with 2TRANSCEND
Integrate additional platforms• Web-based Patient Communication and Care Plan
– Aids in decision making about participating in a clinical trial as well as enabling study staff to communicate with patient’s regarding study appointments
• Web interface allowing patients to directly input:– Adherence to treatment regimens– Adverse events (PRO-CTCAE)– Follow-up information
• Adopt Annotation Imaging Mark-up (AIM) tool to enable researches ability to centrally review and analyze images
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I-SPY 2 TRIAL2TRANSCEND - Integrated Systems
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I-SPY 2 TRIAL
• Dr. Laura Esserman – I-SPY TRIAL, TRANSCEND PI (UCSF)• Dr. Michael Hogarth - TRANSCEND Technical Director (UC Davis)• Meg Young – TRANSCEND Project Manager (UCSF)• Sarah Davis – I-SPY 2 TRIAL Manager (UCSF)
– Joyce Lee, Julia Lyandres (software testing, quality control)
• Sorena Nadaf – Informatics Design (UCSF)• Dr. Angela DeMichele – Clinical Oncology (UPenn)• Don Berry & Kyle Wathen – Randomization Engine (MDACC)• John Churin – Software Lead Engineer (Tolven)• Ashwin Koleth – Software Development (Cyrus-XP)• John Koisch – Architecture (NCI)• Kathy Hajopoulos – Project Oversight (UCSF)• Nancy Roche – Project Oversight (SAIC)
TRANSCEND TEAM
TRANSCEND development funded by the National Cancer Institute (NCI), Subcontract # 28XS197
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I-SPY 2 TRIAL
• Dr. Laura Esserman – I-SPY TRIAL, 2TRANSCEND PI (UCSF)• Dr. Michael Hogarth - 2TRANSCEND Technical Director (UC Davis)• Sarah Davis– 2TRANSCEND Project Manager (UCSF)• Meredith Buxton – I-SPY 2 Program Director (UCSF)• Dr. Angela DeMichele – Clinical Oncology (UPenn)• Don Berry & Kyle Wathen – Randomization Engine (MDACC)• John Churin – Software Lead Engineer (Tolven)• Ashwin Koleth – Software Development (Cyrus-XP)• Eve Shalley – Project Manager (NCI)• Santosh Joshi & CBIIT caCIS Team (NCI)• Ian Fore & CBIIT caTissue Team (NCI)• Paul Baumgarnter & CBIIT caAERS Team (NCI)• Juli Klemm & CBIIT caArray Team (NCI)• Shine Jacob & CBIIT caIntegrator Team (NCI)• Robert Shirley & CBIIT Architechture Team (NCI)
2TRANSCEND TEAM
2TRANSCEND development funded by the National Cancer Institute (NCI), Agreement No. 12ST1002