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Clinical Data Management India as a Hub
Dr. Bhaswat S. ChakrabortySr. VP & Chair, R&D Core Committee
Cadila Pharmaceuticals Ltd.
Ongoing Clinical Trials in India
Source: clinicaltrials.gov
Clinical Trials: Why Do We Need a Data Management System?
• Multi-centre co-operative trials– Multiple sites capturing data
– Multiple disparate databases
– Multiple levels of reporting
– Critical, very specific information
– Multitude decision making at multiple sites
– Co-ordination demands details
– Real time query and real time response
Investigational Sites
Product Management
Project Management
Drug & Clinical Trial Development
Extended Picture
IRB Regulatory Documents
Relationship Building
eMails
Partners & Affiliates
Meetings
CROs
Contracts
Knowledge
Information
Safety
Communication
Resource Management
Data Capture Data Management
Multidirectional Flow of Data and Decisions
Clinical Trials: Why Do We Need a Data Management System?
• Enormous volumes of data– Example, a Phase-III trial in 10 centres with 100 patients
each – 60 pages of CRF for each recruited patient
• 20 fields each page
– 40 pages of screening form for each candidate patient• 20 fields each page
– [1000 (60 x 20)] + [1500 (40 x 20)] = 12, 00000 + 12, 00000= 24,00000 specific data points
Clinical Trial Data• Useful only if it is clean & up to date. • Data processing must be
– real-time• subject randomization• management of clinical trials materials• laboratory uploads• patient diary data
– Integrated– Consistent– Accurate
• Data structures must be– Standard– Validated
• Data transfer method must be– Standard– Validated
Data Management Services: What Exactly Do They Do?
• Case report forms (CRFs) design • Database design • Database programming • 21 CFR part 11 compliant validation process • Loading, reconciliation and integration of external data • Medical coding • Status reporting • Forms management• Data entry and cleaning• Data locking• Statistical analysis• Report generation
Clinical Data Management System (CDMS)
Data Capture Strategy
Remote Data Capture
Portal Data Capture
Processes
Adverse Event Monitoring System
Compliance (GCP/GLP) Monitoring
Workflow Monitoring
Analytical Data Processing
Statistical Data ProcessingSystems
Data Extraction
GLIB
TMS/Dictionaries
Reports
Validation
Data Capture (1)
No
Yes
CRF
Manual data
Electronic data
Raw data
A
Electronic data to be combined?
Raw data (Manual)
Get approval
Clinical Data Management System (CDMS)
Data Capture Strategy
Remote Data Capture
Portal Data Capture
Processes
Adverse Event Monitoring System
Compliance (GCP/GLP) Monitoring
Workflow Monitoring
Analytical Data Processing
Statistical Data ProcessingSystems
Data Extraction
GLIB
TMS/Dictionaries
Reports
Validation
A
Data Extraction, Cleaning & Locking (2)
Real time query
Are the queries answered?
Yes
No
Data cleaning1. Detecting & diagnosing errors2. Editing incorrect data3. Integrated data passage4. Outlier determination5. Robust estimation of analytical parameters
Clean data
Approval required
Can this data be locked?
Yes
NoRepeat Observation/
Omission
Locked data B
Clinical Data Management System (CDMS)
Data Capture Strategy
Remote Data Capture
Portal Data Capture
Processes
Adverse Event Monitoring System
Compliance (GCP/GLP) Monitoring
Workflow Monitoring
Analytical Data Processing
Statistical Data ProcessingSystems
Data Extraction
GLIB
TMS/Dictionaries
Reports
Validation
B
Data Processing & Reporting (3)
Locked Clean Data
Statistical analysis required?
Yes
No
SAS Data SetsStatistical Data AnalysisTests of HypothesesCohort Analyses
ResultsReport
Data Summary, Charts/Graphs
CRF Database
Data Entry Layout
CRF Maker CRF
(Form) Editor
Edited
Hard Copy
Electronic Case Report Forms
Design
Define
Build
Test
Use
Subject Data Entry
(Investig
ational S
ite)
Data Review
Sponsor/Monitor
Central Data
Repository (HUB)
Electronic Data Capture (EDC)21C
FR
Part 11
Co
mp
liance
CDMS Market Size in India
• [Gobally ~$1.5 billion]
• Estimated Indian Market
• The total Clinical Trial market in India is ~$600 million
• CDMS is about 7-8% of CTs
• Thus the CDMS market is estimated to around 40 – 45 million dollars
• For big MNCs, it is still a very small portion
• But it has a huge potential to grow
Clinical Trials Destination: India
Business Models:1. Specialized outsourcing hub2. General hub
Drivers of EDC & CDMS• Context – why India and why EDC & CDMS• Technology & market forces• Cost advantage• Concentration of resources• Expertise (and lathes of expertise)• Regulators are insisting on comprehensive risk
management and PV• Large trials have dozens of international sites and
corresponding chunks of data
Facilitators of EDC & CDMS• Context – why India and why EDC & CDMS• Consultants who can integrate different parts• One stop shopping
– Patients, diversity– investigators– CT conduct experience– Top CROs
• Research subsidiaries of pharma MNCs and int’l CROs• CDMS & EDC offer efficiency and timeliness of data collection
and reporting• Understanding of harmonized data & analysis requirements
Sahoo U. (2005). Clinical data capture shifts paradigm. Pharmabiz, July 14, 2005
Stakeholders in CDMS & EDC
Data Standards & Harmonization• It is estimated that ~ 200 million dollars are wasted yearly
because of a lack of globally accepted clinical data format• Following organizations are working for data standardization:• Clinical Data Interchange Standards Consortium (CDISC)• Health Level 7 (Hl7)• WHO• US National Cancer Institute (NCI)• National Library of Medicine (NLM)• Academia• ISO• …
Jobs in India in CDISC, EDC, Biostats…
Standards for Data Management
• Very important for the regulatory agencies
• Without a standard, sponsors file data in different arrangements
• Once data is in a standardized structure, regulatory agencies can preprogram software to run a macro script
• Thereby data coming from different sources will automatically format to conform to the regulatory agencies requirements
MNC PV Activities & Databases in India
• Example: Novartis• Activities/Databses
– Periodic Safety Update Report (PSUR)– Risk Management Plan (RMP) updates and associated activities– safety signal detection– management of large datasets– analysis of large databases– responses to external authorities– review of clinical protocols– other regulatory activities– clinical review and evaluation of cases including input for follow-up
and data cleaning– ….many other relevant activities
Advantages to MNCs: Outsourcing to India
• Better, safer drugs to market faster• Improve efficiency
• Improve communication• Improve data collection• Reduce redundant data submissions
• Other benefits• Improve communication• Decrease redundant data submission• Decrease “learning curve”• Cross study analysis• User friendly tools• Decrease delays
Technical Advantages• Cloud computing possible• Real-time access to all clinical trial data• Easy filling of e-CRFs with
– Radiobutton choices – Checkboxes – Drop-down selections – Unlimited text boxes for comments
• Real-time data entry validation checks • Secure database • Back-end clinical data management and programmed data
validation checks• Electronic and automatic Audit Trail• Simple e-mail query resolution or by on-line query database• Configurable access rights• Electronic signatures fully compliant with FDA's 21 CFR Part 11
Concluding Remarks• CDMS provide a range of IT tools that give the trials personnel
the required information throughout clinical management
• CDMS mainly manages data capture, systems and analytical process electronically
• EDC definitely adds value – efficiency and accuracy, however, high costs and some technology issues remain
• Technical and automational advantages are countless
• The CDMS market in India is estimated to around 40 – 45 million dollars and growing
• Provides for data standardization and interchange in universally acceptable formats
Concluding Remarks: India as a Hub• India offers many advantages as a CDMS hub
• Cost
• Concentration of resources
• Expertise
• Comprehensive risk management databases, analysis, mitigation and PV centres
• Consolidation of various databases (especially large ones)
• India’s IT sector is growing at ~25% per year thus maintaining complex CDMSs at competitive costs in India is an added advantage
• Abundant skilled personnel in all areas of CDM available• Hub of almost all clinical trial activities in coming years
Thank You Very Much