Stem Cells and Cell-Based Products

Clinical Trial Registry India (CTRI)

Sponsors/organisations who plan to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH are expected to register the trial in the CTRI before enrollment of the first participant from India. Multi-country trials, where India is a participating country, which have been registered in an international registry also require to be registered in the CTRI.

CTRI- A Brief History

The CTRI was launched on 20th July 2007, initially as a voluntary measure; however, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Central Licensing Authority (CLA).

The purpose of the CTRI is to enable all clinical trials conducted in India to be prospectively registered before the enrollment of the first participant. Post-marketing surveillance studies as well as bioavailability/bioequivalence studies are also required to be registered in the CTRI.

In December 2008, the World Health Organization (WHO) recognized CTRI as a primary registry. Every month, data from the CTRI is transferred to the WHO International Clinical Trials Registry Platform, which is a global portal for all registered clinical trials being conducted around the world.

In February 2008, editors of 11 Indian biomedical journals issued a joint statement with a pledge not to accept any unregistered clinical trial for publication in their journal from 2010 onwards.

Goals of Clinical Trials Registry - India

Trials registered in CTRI are monitored to ensure increasing voluntary disclosure of all items in the register. The disclosure of the protocols and results of the registered trials improves transparency and accountability and public confidence in clinical trials. The details expected to be implemented by the investigators improves the internal validity of trials.

The CTRI also acts as an information repository for all the stakeholders such as the researchers, academicians, activists, and the CDSCO. CTRI is also of immense help to the patients and general public; the CTRI includes the name and address details of the study site which may help the patients to identify specialist doctors in their regions, especially people in search of life-saving therapies.

Evidence suggests that some aspects of the trial methodology are particularly important to produce reliable results by minimizing biases, confounders and the effects of chance or coincidence. These aspects include the method of random sequence generation, adequate concealment of allocation of participants to interventions, adequate blinding of participants, investigators and outcome assessors, and inclusion of all participants' results. Disclosing the methodology aspects of the trial by all registrants in the CTRI will increase the chances of publication in a high impact journal that endorses the ICMJE requirement of reporting trials in accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement.

The Indian Council of Medical Research through its Bio-ethics initiative has developed ethical guidelines for the conduct of trials and for ethics committees. Clearance by local ethics committees is mandatory for all clinical trials and disclosure of ethical clearance in CTRI. This will lead to better links with the ICMR's bio-ethics initiative and will provide value addition to the evidence based medicine.

The Clinical Trials Registry of India Data Set

For a trial to be fully registered, the minimum amount of information to be entered in the register is provided under the trial registration data set. The CTRI data set which needs to be submitted are mentioned below:

1. Public title of study – Study title in simple language intended for the lay public

2. Scientific title of the study (Acronym, if any) as it appears in the study protocol

3. Secondary IDs (if any) - Secondary ID includes any Protocol Number or any other Trial Registry Number, registered in a registry other than the CTRI (for example ClinicalTrials.gov).

4. Principal Investigator’s name, official address, affiliation and designation, contact telephone and fax numbers and email ID. In case of multi-centre study (for trials being conducted in India), information of the designated contact (lead Principal Investigator or overall Trial Coordinator) from India should be included.

5. Contact person scientific query and contact person for public query (who will respond to general queries such as current recruitment status)

6. Source/s of monetary or material support

7. Primary sponsor and secondary Sponsor

8. Countries of recruitment

9. Site/s of study

10. Name of Ethics Committee and approval status

11. Regulatory clearance obtained from CLA

12. Health condition/problem studied

13. Study type - Whether the trial is an Interventional trial, Observational trial or Post marketing surveillance. Trial part of post-graduation thesis should be mentioned accordingly

14. Intervention and comparator agent - The International Non-Proprietary Name should be used if possible (not brand/trade names). For an unregistered drug, the generic name, chemical name, or company serial number may be used.

15. Inclusion and exclusion criteria for participant selection, including age and sex

16. Method of generating randomization sequence

17. Method of allocation concealment

18. Blinding/masking

19. Primary and secondary outcome/s

20. Target sample size

21. Phase of trial

22. Date of first enrolment

23. Estimated duration of trial

24. Recruitment status of trial

25. Brief Summary – The summary may include the primary purpose of the protocol, including a brief statement of the study hypothesis. Links to publication/s details may be included if required.

Clinical trial registration allows transparent research and sustains the validity of evidence based practice and availability of reliable data. Sponsors can minimize potential issues by choosing the right partner - CliniExperts has expertise in CTRI submission and CTRI registration over the CTRI online portal. We can be your trusted partner in navigating through this crucial aspect. We have a successful track record of managing trial registrations with CTRI for more than _________ clinical trials. We will work with you to ensure all requirements for trial registration are available as per the data set mentioned by CTRI. Our collaboration will help expedite the tedious application process and ease your work.

Some of the biggest roadblocks to smooth processing can result from communication barriers. CliniExperts will help you identify the bottlenecks in communication and coordinate with the key stakeholders involved in the process in a timely and efficient manner.

We can also assist you in addressing the queries raised by CTRI in real-time and ensure the process is in track.

Once a trial is registered, all updates and changes will be recorded and available for public display. CliniExperts can assist you with the periodic updates needed for the trial on to the CTRI.

.

Summary

• A clinical trial registry - India (CTRI) is an official platform for registering a clinical trial with an objective of providing increased transparency and access to CTs to the public at large.

• The vision of the CTRI is to ensure that every CT conducted in the region is prospectively registered with full disclosure of the trial data set items.

• Trial registration in the CTRI has been made mandatory by the Central Licensing Authority of India.

• All clinical trials conducted in India should be registered before the enrollment of the first participant from India.

References

• Clinical Trial Registry India. ICMR. Available at:http://ctri.nic.in/Clinicaltrials/cont1.php. Accessed on: 08 April 2020.

• Vardhana Rao MV, Maulik M, Gupta J, et al. Clinical Trials Registry - India: An overview and new developments. Indian J Pharmacol. 2018;50(4):208–211.

• Satyanarayana K, Sharma A, Parikh P, et al. Statement on publishing clinical trials in Indian biomedical journals. Indian J Med Res. 2008;127(2):104-105.