Download - CLINICAL TRIAL REGISTRATION IN INDIA
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CLINICAL TRIALS
REGISTRATION IN INDIA
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REQUIREMENT FOR TRIALS REGISTRATION
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VISION• Improve transparency and
accountability• Improve the internal validity of
trials• Conform to accepted ethical
standards• Reporting of all relevant results
of registered trials
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CTRI
• Set up at the National Institute of Medical Statistics (NIMS), ICMR, New Delhi
• Free and online system for registration all clinical trials being conducted in India
• Launched on 20th July 2007 • Initiated as a voluntary measure, since 15th June
2009• Trial registration in the CTRI has been made
mandatory by the Drugs Controller General of INDIA
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What is the International Clinical Trials Registry
Platform? • Network of Primary and Secondary Registers• Developed by the WHO• Ensure that a complete view of research is accessible
to all those involved in health care decision making• Is not a Registry, but collects data (details of
registered trials) from its Primary Registers and displays them from a single search portal
• The ICTRP serves as a one-stop search portal for clinical trials that may be registered in diverse Primary Registers of the world.
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PRIMARY REGISTRIES AND PARTNER REGISTRIES
• A Primary Registry in the WHO Registry Network is a clinical trial registry with at least a national remit that meets WHO Registry Criteria for content, quality and validity, accessibility, unique identification, technical capacity and governance and administration
• Currently 11 Primary Registries in the WHO Registry Network, including the CTRI.
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• Primary Registries: India, New Zealand, China, Srilanka,
Australia
• Partner Registries: USA, European Union
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WHICH TRIALS GET REGISTERED???
• Drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies strategies as well as trials being conducted in the purview of the Department of AYUSH
• Before enrolment of the first participant.
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TRIAL REGISTRATION INVOLVES . . .
• Public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient.
• Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI.
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INFORMATION REQUIRED FOR REGISTRATION
• Public title of study• Scientific title of study• Secondary IDs, if any • Principal Investigator’s name and address• Contact person (Scientific Query) • Contact person (Public Query) • Source/s of monetary or material support • Primary and Secondary sponsor• Countries of recruitment • Site/s of study
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• Name of Ethics Committee and approval status• Regulatory clearance obtained from DCGI• Health condition/problem studied• Study type• Intervention and comparator agent• Inclusion/Exclusion criteria• Method of generating randomization sequence• Method of allocation concealment• Blinding/masking• Primary and Secondary outcome/s
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• Target sample size • Phase of trial • Date of first enrollment• Estimated duration of trial• Recruitment status of trial • Brief Summary
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AFTER TRIAL REGISTRATION
• CTRI scientists review the trial data set for meaningful and relevant entries
• In case of any discrepancies or concerns, the trial may be sent back to the Registrant
• Editing possible• Upon satisfaction of the above criteria, the
trial is registered and trial details viewable from the public domain
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Clinical Trials Registry – India National Institute of Medical Statistics Indian Council of Medical Research Ansari Nagar New Delhi-110029 India Tel: 011-26588725; 011-26588803 Email: [email protected]
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REFERENCES
• www.ctri.nic.in• http://indianmedicine.nic.in/
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