informatics in breast cancer research i-spy 2 trial & transcend
DESCRIPTION
Informatics in Breast Cancer Research I-SPY 2 TRIAL & TRANSCEND. Design goals of I-SPY 2. Screen phase 2 agents in combination with standard chemotherapy in neoadjuvant setting Endpoint is pCR Intermediate endpoint is MRI Volume - PowerPoint PPT PresentationTRANSCRIPT
Informatics in Breast Cancer ResearchI-SPY 2 TRIAL & TRANSCEND
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
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
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
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)
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
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
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
I-SPY 2 TRIAL
TRANSCEND – eCHR Data Collection
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
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
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
I-SPY 2 TRIAL
TRANSCEND - Randomization
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
I-SPY 2 TRIAL2TRANSCEND - Integrated Systems
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
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