CLINICAL TRIAL REGISTRATION IN INDIA

1. CLINICAL TRIALS
REGISTRATION IN INDIA

2. REQUIREMENT FOR TRIALS
REGISTRATION

3. VISION
• Improve transparency and accountability
• Improve the internal validity of trials
• Conform to accepted ethical standards
• Reporting of all relevant results of
registered trials

4. CTRI
• Set up at theNational Instituteof Medical
Statistics(NIMS), ICMR, New Delhi
• Freeand onlinesystem for registration all
clinical trialsbeing conducted in India
• Launched on 20th
July 2007
• Initiated asavoluntary measure, since15th
June2009
• Trial registration in theCTRI hasbeen made

5. What istheInternational Clinical
TrialsRegistry Platform?
• Network of Primary and Secondary Registers
• Developed by theWHO
• 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 displaysthem from asinglesearch portal

6. PRIMARY REGISTRIESAND 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 governanceand administration
• Currently 11 Primary Registries in the WHO
Registry Network, including theCTRI.

7. • Primary Registries:
India, New Zealand, China, Srilanka, Australia
• Partner Registries:
USA, European Union

8. WHICH TRIALSGET
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
• Beforeenrolment of thefirst participant.

9. 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 theCTRI.

10. INFORMATION REQUIRED FOR
REGISTRATION
• Public titleof study
• Scientific titleof study
• Secondary IDs, if any
• Principal Investigator’snameand address
• Contact person (Scientific Query)
• Contact person (Public Query)
• Source/sof monetary or material support
• Primary and Secondary sponsor
• Countriesof recruitment

11. • Nameof EthicsCommitteeand approval status
• Regulatory clearanceobtained 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

12. • Target samplesize
• Phaseof trial
• Dateof first enrollment
• Estimated duration of trial
• Recruitment statusof trial
• Brief Summary

13. 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 besent back to theRegistrant
• Editing possible
• Upon satisfaction of theabovecriteria, thetrial
is registered and trial details viewable from the
public domain

14. Clinical Trials Registry – India
National Instituteof Medical Statistics
Indian Council of Medical Research
Ansari Nagar
New Delhi-110029
India
Tel: 011-26588725; 011-26588803
Email: ctr.nims@gmail.com

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

16. “Theonly way to do great work is
to lovewhat you do. If you haven’t
found it yet, keep looking. Don’t
settle.”
– SteveJobs