Saturday, December 11, 2010

Clinical Trial Registry-India

Clinical Trials Registry-India (CTRI)

The Clinical Trials Registry- India (CTRI) has been set up by the ICMR's National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR). It also receives financial and technical support through the WHO, WHO-SEARO, and the WHO India Country office.

The CTRI is an online register of clinical trials being conducted in India. Any researcher who plans to conduct a trial involving human participants, of any intervention (drug, surgical procedure, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies and complementary therapies) are expected to register the trial in CTRI before enrollment of the first participant. Registration is voluntary but some fields marked* are mandatory for registration to proceed. Some fields marked WHO also need to be filled if the trial is to receive a registration number and fulfill WHO/ICMJE requirements. Incomplete entries will be given a provisional registration number that will not suffice for purposes of publication in journals that endorse the ICMJE recommendations for trial registration. Registration of trials in the CTRI is free. All registered trials will be made publicly available. The CTRI will be searchable by anyone free of charge. The Clinical Trials Registry- India (CTRI) has been set up by the ICMR's National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR). It also receives financial and technical support through the WHO, WHO-SEARO, and the WHO India Country office.

The mission of the Clinical Trials Registry-India (CTRI) is to encourage all clinical trials conducted in India to be prospectively registered before the enrollment of the first participant and to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset.

The primary purpose is to make information regarding clinical trials being conducted in India freely available to anyone who desires the information. Through the Registry, information of all clinical trials taking place across the country in all areas of health - new drugs, treatments, therapies, surgical procedures and new medical devices will become publicly available for the first time

It is important to register clinical trials for both ethical and scientific reasons. Registration of trials ensures transparency, accountability and accessibility of clinical trials and their results. Further, it promotes greater trust and public confidence in clinical research. Trial registration also helps to prevent bias generated by selective reporting of only "positive" findings as well as reduce unnecessary duplication of research through greater awareness of existing trials and results.

As of the present moment, registration is purely voluntary; however, registration is likely to have a lot of advantages both for the registrant as well as the public. Further, prior registration is now a condition of publishing clinical trial data. From 1st July 2005 the International Committee of Medical Journal Editors (ICMJE) have declared that their journals will not publish the results of any clinical trials not included on an authorised register at the trials inception.

All interventional clinical trials conducted in India and involving Indian participants need to be registered. An interventional clinical trial is any research study that prospectively assigns people to one or more health-related interventions (e.g., preventive care, drugs, surgical procedures, behavioral treatments, etc.) to evaluate their effects on health-related outcomes. Thus, early and late trials, trials of marketed or non-marketed products, randomized or non-randomized trials -- all should be registered.

Who is responsible for registering a trial?
The "Responsible Registrant" for a 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 and multi-sponsor trials, it is the lead PI or lead sponsor who should take responsibility for registration. However, in case of multi-country trials, the Indian PI should also get the trial registered in CTRI quoting any other Registration number as its Secondary ID.

Initially, a registrant will have to create a login name and password. This can be done by filling p the form that appears after clicking on the Register Trial button. Once all the mandatory information has been entered, the registrant should click the Submit button. 
Following submission of the personal data, a password confirmation note to the email ID of the registrant will be sent. Thereafter the registrant can use the chosen Username and password to upload the required information on a clinical trial proposed to be conducted. A registrant may fill in the data set items at his or her own convenience by clicking on the save button. A registrant may then edit the fields as required or take a print out of the entered information by clicking on the Print button. The information filled in the fields of the data set items will not be available for the System Administrator till the registrant clicks on the Submit button. Once the data is submitted and until the trial is registered, any trial information is not available for editing by the registrant. Once the data is submitted, the CTRI staff will check the submitted information for completeness and whether informative entries have been provided. If needed, the registrant will be contacted for any queries. Further, the staff will verify that the trial is being conducted through contact with Ethics Committee. Once queries, if any are clarified, the trial will be officially registered and allocated a unique registration number. Both the date of submission and date of registration will be recorded. Registrants are also required to regularly update information on each trial (including patient accrual, trial and publication status). Further, all the WHO fields need to be filled if the trial is to receive a registration number and fulfill WHO/ICMJE requirements. Incomplete entries will be given a provisional registration number that will not suffice for purposes of publication in journals that endorse the ICMJE recommendations for trial registration. If all the necessary fields are filled with valid and informative entries, the trial will be officially registered and allocated a unique registration number. Trials which are not verifiable from relevant sources despite attempts to do so by the CTRI staff, but appear complete with respect to trial information is provided, the trial will be fully registered but a note will mention that it is “Not verified”

1 comment:

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