CLINICAL TRIALS

REGISTRATION IN INDIA

REQUIREMENT FOR TRIALS REGISTRATION

VISION• Improve transparency and

accountability• Improve the internal validity of

trials• Conform to accepted ethical

standards• Reporting of all relevant results

of registered trials

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

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.

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.

• Primary Registries: India, New Zealand, China, Srilanka,

Australia

• Partner Registries: USA, European Union

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.

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.

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

• 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

• Target sample size • Phase of trial • Date of first enrollment• Estimated duration of trial• Recruitment status of trial • Brief Summary

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

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: ctr.nims@gmail.com

REFERENCES

• www.ctri.nic.in• http://indianmedicine.nic.in/

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