|Year : 2017 | Volume
| Issue : 3 | Page : 287-288
Stay calm and register your trial… its time
Rakhee Goyal1, Anju Grewal2
1 Department of Anaesthesia and Critical Care, Army Hospital Research and Referral, New Delhi, India
2 Department of Anaesthesia and Critical Care, Dayanand Medical College, Ludhiana, Punjab, India
|Date of Web Publication||11-Sep-2017|
Department of Anaesthesia and Critical Care, Army Hospital Research and Referral, New Delhi
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Goyal R, Grewal A. Stay calm and register your trial… its time. J Anaesthesiol Clin Pharmacol 2017;33:287-8
One step on the moon is a giant leap for the mankind… and one small research is the genesis of a big revolution.
Fair, lawful, and safe research. A research that has fair intent. A research that is scientific, unbiased and has been conducted in a legitimate manner, with good ethics, and safe medical practices.
Thus, the need for the formulation of “regulatory” bodies. In India, Indian Council of Medical Research (ICMR) fills this role [Figure 1]. Formerly known as the Indian Research Fund Association, founded in 1911 and redesignated in 1949, ICMR has been the institution contributing and regulating the growth and development of medical research in the country. In 1988, Schedule Y of Drugs and Cosmetics Act established the regulatory guidelines for clinical trial permission for Indian pharmaceutical companies. The Central Ethical Committee of ICMR released “Ethical Guidelines for Biomedical Research on Human Participants” in 2000 (revised in 2006).
The Central Drug Standard Control Organization (CDSCO), a division in Ministry of Health and Family Welfare centrally sets standards for drugs and monitors any adverse drug reactions whereas the manufacture and sale is under the respective state governments and union territories through their respective drug control organization (www.cdsco.nic.in). In 2001, CDSCO released “Indian Good Clinical Practice Guidelines” and in 2005 it made major revisions with Schedule Y so that Indian research could be integrated to the global clinical development by means of standard definitions and procedures. This included clear definitions for Phase I-IV trials, responsibilities for investigators and sponsors, and stringent requirements for notifying changes in protocol.
The Clinical Trials Registry-India (CTRI), an initiative of National Institute of Medical Statistics, under the aegis of ICMR, was launched in 2007 as a free online portal for registration of clinical trials (www.ctri.nic.in). Since June 2009, CDSCO, headed by the Drugs Controller General (India) (DCGI) has made CTRI registration mandatory for all clinical trials in the country, including multicountry trials where India is a participating country.
CTRI is one of the 11 Primary registries in the WHO Registry Network that meets the WHO Registry Criteria for content, quality and validity, accessibility, unique identification, technical capacity, and governance and administration (http://www.who.int/ictrp/en/). An editorial by Kaul and Grewal, published in this journal in 2008 elaborates on the role of the WHO International Clinical Trials Registry Platform and highlights the reasons why trials should be registered [Figure 2].
CTRI targets to register all trials that involve human participants, pertaining to 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 (http://indianmedicine.nic.in/) before the enrollment of the first participant, also called prospective registration. However, currently, CTRI is also registering trials that have recruited participants before trial registration, i.e., retrospective registration. Approval of Ethics Committee is mandatory for CTRI registration. Some studies may also require DCGI approval, wherever applicable.
CTRI is a public display platform where all the information such as details of investigators, sponsors, sites of trial, sample size, intervention, comparator agents, date and type of enrollment are up for public scrutiny after trial registration. It can be accessed from CTRI website as well as the International Clinical Trials Registry Platform (http://www.who.int/ictrp/search/en/). The investigators upload regular updates on the trial status and data collection on the website. This renders more accountability and enhanced transparency to any research.
To improve the internal validity of trials, CTRI urges its investigators to disclose the details of the methods of the trial such as randomization, concealment, blinding as well as the participants' results at the protocol stage of the study.
To begin with, the investigator has to register and get a username-password on www.ctri.nic.in. “Add new trial” takes you on to the self-explanatory steps that allow you to add every detail required by the registry and the “help” icon suggests solutions at every step. The user gets a Universal Trial Number that can be used for all further references. The trial committee goes through the submitted application meticulously and asks for clarifications, where required. Once the committee clears the trial, a registration number is assigned. It is important to know that the first patient of the study is recruited only after the trial is registered. The investigators can upload the progress of the trial on the website at necessary intervals.
Journal of Anaesthesiology and Clinical Pharmacology is now taking a step forward and the editorial board has decided that from January 2018 onward, CTRI registration would be mandatory for all trials submitted to the journal. We request all our authors to strictly comply by the journal guidelines with regard to CTRI registration. The editorial board will accept the submission of only those manuscripts that have been registered with CTRI prospectively. The authors will have to endorse the registration number of their trial in the manuscript at the time of submission.
We sincerely urge all our contributors to help us strengthen our mission. Let the niche for the scientific literature be ethical, safe, transparent, auditable, and meaningful.
If we do not progress, we regress, so we believe. And in you, we trust.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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Imran M, Najmi AK, Rashid MF, Tabrez S, Shah MA. Clinical research regulation in India-history, development, initiatives, challenges and controversies: Still long way to go. J Pharm Bioallied Sci 2013;5:2-9.
Kaul TK, Grewal A. Registration of clinical trials: A mandatory prerequisite. J Anaesth Clin Pharmacol 2008;24:257-8.
[Figure 1], [Figure 2]