CoopGroupTBPTToolAdop Richards Billiter

Slide1: 

Cooperative group adoption of TBPT tools Barriers and Solutions Face to Face October 9, 2007 William G Richards, PhD Dave Billiter, PMP

Clinical Trials Cooperative Groups Program: 

Clinical Trials Cooperative Groups Program 12 Cooperative groups 1700 institutions 22000 participants per year on treatment trials Ideal source of cancer biospecimens Large numbers of patients, representative of general population Cohorts of patients uniformly treated and carefully followed Prospective data collection, central data management Central repositories, uniform handling, economies of scale Logistical challenges to specimen banking Participant institutions geographically dispersed Shipping, tracking, quality assurance

Diverse sources of accrual to cooperative group trials: 

Diverse sources of accrual to cooperative group trials Cooperative Group Trial Community Clinical Oncology Program Main Member Institutions Affiliate Institutions Clinical Trials Support Unit Institutions affiliated with Other Cooperative Groups

Barriers to using TBPT applications within Cooperative Group environment.: 

Barriers to using TBPT applications within Cooperative Group environment. CAE Difficult to implement centrally (isolated from institutional EMR) Existing annotation and audit process CRFs > DMC (error prone) caTIES No electronic access to Institutional Pathology reports caTissue Core Registration, consent, inventory, Q/C, and tracking data maintained in separate DBMS at separate sites High-volume processing at repositories requires customized workflow management, minimal data entry, time efficiency Group policies may limit annotation data that can be exposed caTissue duplicates existing infrastructure that is “trusted” by IRBs registration, consent monitoring, security, staff roles, PHI protection, blind correlative science, data monitoring, data sharing, etc.

Lung Cancer Tissue Bank (LCTB): 

Lung Cancer Tissue Bank (LCTB) Use Case 18 collecting sites, 1 Repository Lab, 1 Protocol Collection events Baseline blood >> LCTB DNA > aliquots Serum > aliquots Frozen Tissue >> LCTB Tumor > aliquot sets (variable #, +/- OCT) Normal > aliquot sets (variable #, +/- OCT) FFPE Tissue >> PCO Tumor > block or 10 unstained slides Follow-up blood >> LCTB Serum > aliquots Plasma > aliquots Buffy coat

Data flow for CALGB Lung Cancer Tissue Bank Use Case: 

Data flow for CALGB Lung Cancer Tissue Bank Use Case Data management center CALGB IS Lung Cancer Tissue Bank Registration Labtrak Protocol Data Inventory/QC Inventory/QC Inventory/QC PCO Leukemia Tissue Bank Receive samples Receive samples Collection site CRFs Ship samples Register Consent Q/C

Lung Cancer Tissue Bank Inventory QC DBMS: 

Lung Cancer Tissue Bank Inventory QC DBMS Shipment Received Log case dates, patient ID, shipment ID Confirm contents Log sample sets by labtrak id Histology Nucleic acid extraction Log histology data, extraction Q/C Storage in freezer Log subsamples Subprocessing Distribution Print Histology coding sheet for case Split aliquots among freezers; Print barcoded labels Track freezer space; Generate location codes Lung Cancer Tissue Bank Inventory And Process Control DBMS Log distribution

Specimen collection process - Labtrack data flow: 

Specimen collection process - Labtrack data flow Consent R e g i s t e r Pre-op Blood Draw * S u r g e r y Approved Main Member or Affiliate Ship Blood * Tissue* Tumor Lung Lymph node(s) S t o r a g e Ship Tissue ± Serum * LCTB Repository S t o r a g e OSU PCO Receive * Receive * Extract DNA Q/C H+E RNA Ship Slides * Receive * Q/C * Log in LabTrak F o l l o w u p Post-op Blood Draw * Receive * Ship Blood * S t o r a g e Plasma, buffy Q/C Ship Paraffin Block or Slides * Receive * Serum

Group Banking Committee - Informatics Subcommittee: 

Group Banking Committee - Informatics Subcommittee Cooperative groups charged with developing electronic reporting of Group biorepository inventory and utilization. Standardize, use CDEs Dynamic - update >= monthly Accommodate variety of DBMS in use at Group Banks Groups with > 1 biobank should coordinate reporting

Group Banking Committee (GBC)Reporting Mechanisms: 

Group Banking Committee (GBC) Reporting Mechanisms Dave Billiter, PMP Informatics Manager The Research Institute at Nationwide Children’s Hospital COG/GOG Tissue Bank

Cooperative Group Bank Participants: 

Cooperative Group Bank Participants Gynecologic Oncology Group (GOG) Children’s Oncology Group (COG) American College of Surgeons Oncology Group (ACOSOG) Cancer and Leukemia Group B (CALGB) Eastern Cooperative Oncology Group (ECOG) North Central Cancer Treatment Group (NCCTG) Clinical Trials Group of the National Cancer Institute of Canada (NCIC CTG) National Surgical Adjuvant Breast and Bowel Project (NSABP) Radiation Therapy Oncology Group (RTOG) Southwest Oncology Group (SWOG)

Group Banking Committee (GBC): 

Group Banking Committee (GBC) The purpose is to improve the operation of the clinical oncology cooperative group human specimen banks and to coordinate banking activities among groups conducting phase III and large phase II clinical trials. To the extent possible, common collection and storage practices should be developed and implemented. The GBC will act as a steering committee to develop policies with milestones for implementation.

Group Banking CommitteeFocus Areas: 

Group Banking Committee Focus Areas Coordination of Activities Best practices for collection, storage and distribution of biospecimens Common data structures for banking and data exchange Principles and processes for utilization of banked specimens and data Meeting the needs of emerging technologies

GBC Scope of Work: 

GBC Scope of Work Extends to oversight of all aspects of the management and use of clinical oncology cooperative group human specimen banks and their resources. Assumes coordination of processes by which the NCI or the individual cooperative groups choose which investigators are approved to access the specimens.

GBC Informatics Project Vision: 

GBC Informatics Project Vision Harmonization of Cooperative Group Banks Standard Progress Reports Functional data entry, report and query tool Data exchange standard Investigator query tool Integration with other NCI programs

GBC Informatics Project Challenges: 

GBC Informatics Project Challenges Requirements gathering Communication Group Buy-In Resources Technical Capabilities Non-standardization Prioritization

GBC Informatics Project Status: 

GBC Informatics Project Status SDLC status (productype) Technical contacts identified Group Banks participation Finalizing SOW

GBC Reporting Application Productype: 

GBC Reporting Application Productype http://www.c3big.org/GroupBankingCommittee/Login.aspx

CALGB proposal for Integrated GBC Reporting: 

CALGB proposal for Integrated GBC Reporting

Possible Grid-enabled solution for Integrated GBC Reporting: 

Possible Grid-enabled solution for Integrated GBC Reporting CALGB Inventory Web Services Lung Cancer Tissue Bank (LCTB) Leukemia Tissue Bank (LTB) Pathology Coordination Office (PCO) Repository Inventory Management System (CALGBRIMS) Report Inventory Report Inventory CALGB Database Registration GBC Inventory Database [Insert / Update / Delete] [Update Inventory] Replication Interface caTissue Core Grid object Publish Consent Annotation

caTissue Migration Tool: 

caTissue Migration Tool Legacy Inventory DBMS Oracle or MySQL Database Mapping Data Pump Staging caTissue DB Migration engine (caTissue API) Error log Correct errors Resubmit records Production caTissue Instance

Potential solution: Cross platform replication to caTissue: 

Potential solution: Cross platform replication to caTissue Legacy Inventory DBMS Oracle or MySQL Database Mapping Triggered updates Staging caTissue DB Migration engine (caTissue API) Error log Correct errors Resubmit records Adjust source, mapping algorithms Production caTissue Instance Registration Specimen tracking Annotation data Q/C data

Possible obstacles: 

Possible obstacles Straight forward adaptation of migration tool Registration Acquisition Inventory management Drop/replace versus additional development Distribution Subsampling Consent status changes on-study status changes Relocation tracking

Advantages: 

Advantages Permit local UI customization independent of caTissue version upgrades Publish only de-identified data to limit PHI exposure outside cooperative group firewall GRID-enable cooperative group specimen inventory leverage powerful query tool fulfill GBC reporting commitments allow cooperative groups to retain traditional data security function