Understanding about the Indian Clinical Trial Registry – CTRI

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What is a Clinical Trial Registry (CTR)?

What is a Clinical Trial Registry (CTR)?

Before going into the topic, we must first understand what is meant by a clinical trial registry. It can be simply called as an official platform cum catalog for the purpose of registering a clinical trial. In some nations, it is essential to register the clinical trials that are to be conducted in the particular country whereas in some other nations, this is not mandatory though they are strongly recommended. (1)

Need for a Clinical Trial Registry:

Clinical trials are those processes which are holding lots of potential for benefiting patients. In addition, the clinical trials would lead to the improved therapeutic regimens and hold the promise of advancements in medical practices. It is to be noted that the data as well as reports that are obtained from the clinical trials are not easy to find. In few cases, the data do not even exist. This is because; some of the trials have been abandoned while some of them are not published. This practice is not equivalent with the evidence-based medicine.

At present, the need for transparency and accessibility has been felt all over the globe for the purpose of establishing public trust in clinical trial information. This would be possible only when the clinical trials are registered in any of the clinical trial registries. (2)

Clinical Trials Registry - India (CTRI):

Clinical Trials Registry - India (CTRI) was launched during the year 2005. This registry was hosted at the National Institute of Medical Statistics. And, it was during the year 2009; registration of clinical trials became mandatory. Furthermore, the editors of the leading biomedical journals declared that the clinical trials would be considered for publication only if they are registered. Indian CTR is an online record system which is available for free public access. This registry is one among the primary registers of 'International Clinical Trials Registry Platform'. (1), (2)

Homepage of Indian CTR: http://ctri.nic.in/Clinicaltrials/login.php (4)

Objectives of CTRI:

The primary objective of CTRI is to encourage each and every clinical trial that is being conducted in the country to be registered before the enrolment of first subject into the clinical trial. However, the trials that are closed for participant recruitment as well as those trials that are completed can also be registered with the registry.

All the trials that are registered here will be monitored for the purpose of ensuring the voluntary disclosure of each and every item that is listed in the registry. These are done for:

- Improving the transparency as well as accountability

- Improving the internal validity of clinical trials

- Conforming to ethical standards

- Reporting of all relevant results (2)

Registering a Clinical Trial with Indian CTR:

In order to register a clinical trial with CTRI, the trialist should register with the site. This can be done by accessing the homepage of the website and filling the 'NEW USER' form. Upon submitting this online form, the trialist will get the username and password. This registration will be confirmed by an automated e-mail.

With this username and password, the trialist could login to CTRI and start registering his/her clinical trial by clicking the 'TRIAL REGISTRATION' tab. Here, you will have to fill the form that will be available in several parts. After filling out all the data fields, you can submit the trial to the registry after selecting either of the following options:

- Approved/No Objection Certificate - For EC approval status

- Obtained/notified - For DCGI approval status

What Happens Next?

Once the clinical trial data has been submitted, the CTRI scientists will be reviewing the trial data set to check whether they are meaningful and relevant. Then, the EC and DCGI approval documents will be checked and subsequently, verification E-mails will be sent to Principal Investigators and Contact persons of the particular trial in review. If any discrepancies found, the trial will be sent back to the registrant for modifications or clarifications. When all the aforementioned criteria are satisfied, the clinical trial will be registered and will be available for public view. However, EC and DCGI approval documents will not be available for public viewing. (3)

CTRI Dataset:

Following will be the list of data that will be available in Indian CTR for public viewing:

- Public Title of study

- Scientific Title of study

- Secondary IDs

- Principal Investigator's Name and Address

- Contact person (Scientific Query)

- Contact person (Public Query)

- Source(s) 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

- Study Type

- Intervention and comparator agent

- Inclusion/Exclusion Criteria

- Method of generating randomization sequence

- Method of allocation concealment

- Blinding/masking

- Primary outcome(s)

- Secondary outcome(s)

- Target sample size

- Phase of trial

- Date of first enrolment

- Estimated duration of trial

- Recruitment status of trial

- Brief Summary (5)

Searching a Clinical Trial in CTRI:

In order to retrieve trial information of a particular clinical trial in CTRI, one must make use of Search/Advanced Search Options available. While searching, you must enter a keyword/phrase into the keyword text box. Then, select the specific types to search from the drop down list. The drop down list is available for the following criteria:

- Study Design

- Trial Phase

- Recruitment Status (Indian)

- State

- District

When you have found a clinical trial you are interested from this search, you can then learn more about the particular trial by clicking on the link which would take you to the clinical trial record in the source register. (6)

Other Features of CTRI Website:

Upon landing the homepage of CTRI website, you can find the 'News/Highlights' section from where you can read about some of the important events. Then, when you navigate to the 'Publications' section, you can be able to read some important publications about CTRI. Then, the 'Secretariat' tab will give you the details about the personnel of CTRI. Finally, there is a place for 'Feedback' where the people can post their feedback about the registry. If you have trouble navigating through the pages of CTRI, you can use 'Sitemap' which would be of help to you. (4), (6), (7), (8), (9), (10)

References:

(1) http://en.wikipedia.org/wiki/Clinical_trials_registry

(2) http://ctri.nic.in/Clinicaltrials/cont1.php

(3) http://ctri.nic.in/Clinicaltrials/faq.php

(4) http://ctri.nic.in/Clinicaltrials/login.php

(5) http://ctri.nic.in/Clinicaltrials/CTRI_Dataset_and_Description.doc

(6) http://ctri.nic.in/Clinicaltrials/advancesearchmain.php

(7) http://ctri.nic.in/Clinicaltrials/publications.php

(8) http://ctri.nic.in/Clinicaltrials/sect.php

(9) http://ctri.nic.in/Clinicaltrials/feedback.php

(10)http://ctri.nic.in/Clinicaltrials/sitemap.php

About the Author

Tharani Rajamanickam's picture

I am Tharani. I have Bachelors degree in Biotechnology. I am passionate about the healthcare and medical industry and continue to explore, learn and share and I bring in a wealth of knowledge and expertise to help you keep updated with current trends and developments. I have gained a lot of experience in clinical field by working in clinical trials arena. Stay tuned..

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