The Clinical Trial Registry of India (CTRI), owned and hosted at the ICMR’s National Institute of Medical Statistics. CTRI is a free and online public record registry. All the clinical trials which are conducted in India should be registered Clinical Trial Registry of India (CTRI).
Registry was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure. From15th June 2009, trial registration in the CTRI has been made compulsory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in).
Moreover, Editors of 11 major journals of India declared that only registered trials would be considered for publication. The CTRI ( www.ctri.nic.in) is an online, free and searchable system for the prospective registration of all clinical studies being conducted in India. In addition, the CTRI also registers clinical studies being conducted in countries which do not have a Primary Registry of their own.
Today, any researcher/sponsor/investigator/Institute who plans to conduct a clinical trial involving human participants, of any intervention such as drugs, surgical procedures, educational or behavioral treatment, preventive measures, lifestyle modifications, devices, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the clinical trial in the CTRI before enrollment of the first participant.
Primary Registry: The WHO has set up a Registry Network wherein clinical trial registries with specific criteria for quality content, validity, accessibility, etc. are designated as Primary Registries. There are currently 17 Primary Registries of the WHO, including the CTRI.
Hence data of CTRI is also searchable from the WHO’s International Clinical Trials Registry Platform (ICTRP). The ICTRP search portal ( http://apps.who.int/trialsearch/) provides a single point of access to trials registered across its network of registries. The US registry, i.e. ClinicalTrials.gov. although the largest data provider to the ICTRP it is not a Primary Registry of the WHO.
Who is responsible for registering a trial or is it mandatory to register clinical trials with the clinical trial registry of India?
A responsible Registrant, Trialist, or User is authorized to register clinical trials in the CTRI. Registration in the CTRI is needed to gain access to this facility.
The “Registrant” for a clinical trial is either the principal investigator (PI) or the primary sponsor, to be decided by an agreement between the parties. The primary sponsor is ultimately accountable for ensuring that the trial is properly registered. For multi-center or multi-sponsor trials, it is the lead Principal Investigator or lead sponsor who should take responsibility for registration. It is mandatory to register clinical trials with the clinical trial registry of India/
Why should trials be registered in the CTRI?
Registration of all regulatory clinical trials is mandatory as per the drug licensing authority in India i.e. the Drugs Controller General (India) (DCGI). In addition, several journal editors, ethics committees and medical colleges have made it mandatory to register clinical studies in the CTRI.
The following information is recorded in the CTRI:
- Public title of study
- Scientific Title of the Study (Trial Acronym, if any)
- Secondary IDs
- Principal Investigator’s Name and Address
- Contact Person (Scientific Query)
- Contact Person (Public Query)
- Sources of monetary or material support
- Primary Sponsor
- 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
- Intervention and Comparator agent
- Key inclusion/Exclusion Criteria
- Method of generating randomization sequence
- Method of allocation concealment
- Blinding and masking
- Primary Outcome/s
- Secondary Outcome/s
- Status of Trial
- Phase of Trial
- Study Type
- Date of first enrolment
- Estimated duration of trial
- Target sample size
- Brief Summary
- Date of actual study completion
- Final enrolment number achieved
Once a trial is registered in the CTRI it cannot be deleted. However, if the trial is not conducted for some reason, the status of trial should be changed to Terminated and reason cited in the Brief Summary section. Suspended trials also need to follow the same procedure
To find out the Trials on CTRI website, follow the below steps;
- Visit the site http://ctri.nic.in/Clinicaltrials/login.php
- Type in “Keyword Search” to find out the Trial. The trial can be searched by Drug name, Indication or City name,
- List of registered trials will be displayed as below;
- Select the Trial
- Scroll down and click on view selected the view trial;
- Window will pop up with the details;
- Advance Search which is to filter by study designs, trial phase, sponsor and city;
Thank you for reading.
Content Editor : Shahenaz Karadesai