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Clinical data management india as a hub

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  • GLIB: global library is an organization wide central repository for containing standardized data definitions. TMS: thesaurus management system; e.g., Oracle TMS provides terminology services for Oracle Clinical, Oracle Remote Data Capture, Oracle Adverse Event Reporting System, and Oracle Life Sciences Data Hub. Allows access to any number of dictionaries, including multiple versions of the same dictionary ; supports any number of hierarchy levels and supports custom or commonly used dictionaries, such as MedDRA, MedDRAJ, MedDRA SMQs, SNOMED, ICD9, WHO-ART, and WHO-Drug. MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). MedDRA is used in the United States, European Union, and Japan. Its use is currently mandated in Europe and Japan for safety reporting.
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    • 1. Clinical Data Management India as a Hub Dr. Bhaswat S. Chakraborty Sr. VP & Chair, R&D Core Committee Cadila Pharmaceuticals Ltd.
    • 2. Ongoing Clinical Trials in India Source: clinicaltrials.gov
    • 3. 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
    • 4. Knowledge Investigational Sites Contracts Partners & Affiliates CROs Relationship BuildingMeetings Communication IRB Data Capture Regulatory Data Management Documents ProductSafety Management Project eMails Management Resource Management Information Drug & Clinical Trial Development Extended Picture Multidirectional Flow of Data and Decisions
    • 5. 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
    • 6. 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
    • 7. 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
    • 8. Clinical Data Management System (CDMS)Data Capture Strategy Processes Remote Data Capture Adverse Event Monitoring System Portal Data Capture Compliance (GCP/GLP) Monitoring Workflow Monitoring Analytical Data Processing Systems Statistical Data Processing Data Extraction GLIB TMS/Dictionaries Reports Validation
    • 9. Data Capture (1) CRF Manual data Electronic data No Raw data to be combined? (Manual) Yes Electronic Get approval data Raw data A
    • 10. Clinical Data Management System (CDMS)Data Capture Strategy Processes Remote Data Capture Adverse Event Monitoring System Portal Data Capture Compliance (GCP/GLP) Monitoring Workflow Monitoring Analytical Data Processing Systems Statistical Data Processing Data Extraction GLIB TMS/Dictionaries Reports Validation
    • 11. Data Extraction, Cleaning & Locking (2) A Real time query No Are the queries answered? Approval required Yes Repeat NoData cleaning Observation/ Can this data be locked?1. Detecting & diagnosing errors Omission2. Editing incorrect data3. Integrated data passage Yes4. Outlier determination5. Robust estimation of analytical parameters Clean data Locked data B
    • 12. Clinical Data Management System (CDMS)Data Capture Strategy Processes Remote Data Capture Adverse Event Monitoring System Portal Data Capture Compliance (GCP/GLP) Monitoring Workflow Monitoring Analytical Data Processing Systems Statistical Data Processing Data Extraction GLIB TMS/Dictionaries Reports Validation
    • 13. Data Processing & Reporting (3) B Locked Clean Data No Data Summary, Statistical analysis Charts/Graphs required? Yes SAS Data Sets Statistical Data Analysis Tests of Hypotheses Cohort Analyses Report Results
    • 14. CRF Maker CRF Data Entry Editor (Form) LayoutCRFDatabase Edited Hard Copy Electronic Case Report Forms
    • 15. Electronic Data Capture (EDC) Define gn Desi Bu ild C en ry R tr nt ) ep a E ite os l D a Compliance 21CFR Part 11 ta tD a lS ito ta na Test c o ry u bje ati (HS tig U v es B (In ) Data Review Sponsor/Monitor Use
    • 16. 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
    • 17. Clinical Trials Destination: India Business Models: 1. Specialized outsourcing hub 2. General hub
    • 18. 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
    • 19. 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
    • 20. Stakeholders in CDMS & EDC Sahoo U. (2005). Clinical data capture shifts paradigm. Pharmabiz, July 14, 2005
    • 21. 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• …
    • 22. Jobs in India in CDISC, EDC, Biostats…
    • 23. 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
    • 24. 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
    • 25. 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
    • 26. 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 FDAs 21 CFR Part 11
    • 27. 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
    • 28. 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
    • 29. Thank You Very Much

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