How to register a clinical trial in India?

Sir,

In reference to the editorial article “IJD: Consorting with CONSORT” published in your esteemed journal in January 2013,[1] we would agree that the adoption of the international CONSORT guidelines by the journal is a very appropriate step toward better reporting and, hence, improved publication of randomised controlled trials (RCTs) in IJD.

The article mentions the importance of registering a trial in a public access trial registry prior to onset of the trial in World Health Organisation (WHO) registry i.e., International Clinical Trial Registry Platform (ICTRP). In this respect, we would like to state that India launched its own registry, Clinical Trial Registry - India (CTRI) on July 20, 2007 (www.ctri.nic.in). We therefore intend to elaborate on the registration process available for researchers in India.

CTRI is a free and online public record system for registration of clinical trials conducted in India. It was initiated as a voluntary measure; however, registry was made mandatory by the Drug Controller General of India (DCGI) since June 15, 2009.[2] CTRI was hosted and set up by National Institute of Medical Statistics (NIMS), one of the institutions of Indian Council of Medical Research (ICMR), and funded jointly by the Department of Science and Technology (DST), ICMR, and WHO.[3] Registration of trials ensures transparency, accountability, and accessibility of clinical trials.

What to Register?

All trials conducted in India, randomized or not, involving human participants, of any intervention such as drugs (already in the market or otherwise), surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioural treatment, rehabilitation strategies, as well as trials being conducted in the purview of the Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy (AYUSH) (http://indianmedicine.nic.in/) are expected to register.[2]

Clinical trials undertaken by postgraduate students for their thesis should be also registered, as it facilitates publication. There is a separate section dedicated to postgraduate thesis in the CTRI website.

The golden words are “When in doubt, better register.”[3]

When to Register?

The trial should be registered in the CTRI before enrolment of the first participant.[23]

However, CTRI till present permits registration of ongoing trials.[23]

Who Registers?

It is the duty of the principal investigator (PI) to register the trial.[23]

Prime sponsor can register if so agreed in the Memorandum of Understanding.[23]

In a multi-centric or multi-sponsored trial, the lead PI or lead sponsor should register the trial.[23]

In multi-national trial, the Indian PI should register the trial in CTRI, mentioning the relevant registration numbers in registries of other countries.[23]

How to Register?

One should first login to CTRI website: www.ctri.nic.in[2]

Following which, he/she should register himself in CTRI using “Username” and “Password” and create his/her profile. Once registered, he/she can go ahead with registration of the trial.[2]

New trial is then added using the CTRI registration data set as detailed in Box no. 1 using the user friendly registration system.[2]

Box 1

CTRI registration dataset

The above dataset is submitted to CTRI.[2]

A reference number of the trial is given by CTRI.[2]

CTRI checks the dataset and sends back trial for clarification/modification if found incomplete/inappropriate. The person registering has to clarify details before any further procession.[2]

CTRI verifies the trial from “PI, contact person of scientific and public query” (who can be the same or different individuals).[2]

A unique registration number is provided to the trial once found complete and verified. This registration number needs to be stated while submission of the study in any journal.[2]

Practical Tips for Registration

For postgraduate thesis: The concerned guide of postgraduate thesis should account as the PI while registering.

Without the attachment of the scanned Ethics Committee approval letter, the submission of trial is “incomplete.”

For “public title,” medical jargons are to be avoided and it should be written in easy-to-understand words for lay people. e.g., instead of “efficacy” or “effectiveness,” the word ‘effect’ may be used.

“Acronym” is an easy to use abbreviation of the trial. e.g., for a trial “A single-blind randomized controlled clinical study comparing the Efficacy, tolerability and Safety of Levocetrizine and Olopatadine in chronic urticaria,” acronym “ESLO” may be used.

“Secondary id” is any number associated with the trial, for example, the number of an already registered multi-centric trial in another registry (Universal Trial Number UTN) or protocol number. It is not a mandatory section.

If the study is an academic exercise (investigator-initiated trials), the source of monetary/material support should be acknowledged as “Institutional” because source of patients or investigational/medicine support is borne by the institute.

Primary sponsor may or may not be the funding agency, but it is responsible for initiation, conduct, and management of the study. e.g., the investigator in an investigator-initiated trial can be the primary sponsor.

It is the responsibility of the sponsor to ascertain whether DCGI approval is required or not.

International Non-proprietary Name (INN) is to be used if possible (not brand/trade names). For an unregistered drug, the generic name, chemical name, or company serial number is acceptable. For each intervention, description of other intervention details should be provided (e.g., dose, duration, mode of administration).

Most importantly, registering once is not the end of the exercise and data (e.g., recruitment status, results, adverse events) are to be updated in the registry time to time as the trial progresses.

Since IJD intends to implement clinical trial registration mandatory in 2014[1] for trials to be considered for publication, we felt that a brief overview of the registration process with practical tips would benefit the authors. This open access registry can also be used by reviewers, editors and, last but not the least, readers of the journal who can refer back and check the originality of the trial methods and results if they want.