best practices for clinical trial sample data management
DESCRIPTION
The path to realizing the full potential of samples collected in the course of clinical trials has fast become a data problem. Trials are global, increasingly externalized with multiple stakeholders, generate large amounts of data, and operate in a ever-changing regulatory landscape. In this presentation from the recent Molecular Medicine Triconference, we discuss seven key emerging best practices for sample related data management in clinical trials.TRANSCRIPT
Seven Steps to the Sample Life: Best Practices for Clinical Trial Sample Data Management
Mark A Collins, Ph.DDirector of Marketing
Molecular Medicine Triconference Feb 10-12, San Francisco
Booth #413
WHY?
“Companies that have access to millions of highly annotated biospecimens with clear consent, traceability and tools to rapidly mine for desired profiles will have an edge in biomarker-based discovery, segmenting patients for clinical trials and developing companion diagnostic /theranostic applications”
How do we get there?
Thousands of trials
Tens of Thousands of patients
Millions of samples
Millions of data points (and growing)
Increasing externalization
Global trials
Complex consent landscape
Large amounts of complex data
Traditional sample management operations
consents
externalization
clinical
molecular
science
future use
regulatory
Virtual biobanks
knowledgebase
Next generation sample management[where the industry is heading)
Dr Steven Bova, MD.Johns Hopkins
Revolutionizing the understanding of prostate cancer to guide personalized therapy
• 30,000 samples• 150,000 pathology slides• 1000’s of genes• 100’s patient visits • 33 patients• 14 years
One system for sample and sample data management
Biobanking for the personalized medicine era
The Next Generation Biobanking informatics platform
Living the 7-Steps(getting with the program).
1 Understand the whole (data) picture
Collect and Harmonize Data.
• 1000’s of trials• 1000’s of subjects• 100’s of trial sites• Millions of samples• Billions of data points
Does sample data management feel like this..
Multiple, disparate data sources
SEP
22
Need to harmonize and aggregate the data & provide access
Harmonization of disparate data
A hub of harmonized information linking patient, specimen, consent, clinical and molecular data
SEP
22
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Overcome Information bottlenecks
Right data, Right People, Right Time
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2 Know that “no” really means no
Comprehensive Consent Tracking.
Real time dashboards of consent information
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3 Knowledge is Power
Specimen “immortality”.
Generating Scientific Insights
Knowledgebase of harmonized information
Clear consent
Powerful, ad hoc query tools
Generate scientific insights
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Long after the specimen is exhausted we can still mine the data
Can you easily ask your biobank?
Patient Profile
DCIS
T size>1cm, ER+, HER2/neu+, Node negative
Radiation therapy
BRCA1 mutation 185delAG
HOXB7 gene overexpression
Tissue banked for immunohistochemistry?
What is the incidence of breast cancer recurrence in patients with the following profile?
Type of Data
Clinical
Genotype
Gene Expression
Sample Management
Patient Profile
DCIS
T size>1cm, ER+, HER2/neu+, Node negative
Radiation therapy
BRCA1 mutation 185delAG
HOXB7 gene overexpression
Tissue banked for immunohistochemistry?
Scientific Insights
4 Network, Network, Network
Support the Distributed Research & Trial Ecosystem.
Unlike Dr. No – we don’t do research on an isolated island anymore…
Support for externalization
Labmatrix offers, secure access & role based security to ensure all collaborators have appropriate access
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5 Trust but verify
Ensure compliance with robust chain-of-custody and audit trails.
Enhanced Security & Compliance
360o consent tracking, chain of custody and audit trials
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6 Do Sweat the small things
Day-to-day operational management.
Operational Workflows
Operational Workflows
Operational Workflows
Operational Workflows
7 Reduce Waste
Track site collection rates.
Reconciliation
Design
Expectation Reality
Operational Tracking
Operational Tracking
Labmatrix 7 Steps Scorecard• Reduction in time to release samples – days to
hours• Improved compliance• >40% reduction in costs from sample over-
collection• >30% reduction in costs for sample
procurement• Improved ability to respond to unplanned events
in-trial• Greater confidence in data• Holistic view of the trial – “sample EDC”• Scientific insights & hypothes generation
THANKYOU.
Download the 7-Steps:Best Practices Checklist
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