trials hold enormous potential for benefiting patients, improving therapeutic
regimens and ensuring advancement in medical practice that is evidence based.
Unfortunately, the data and reports of various trials are often difficult to
find and in some cases do not even exist as many trials abandoned or are not
published due to "negative" or equivocal results. However, this
tendency for availability of only selective information from the myriad
clinical trials conducted is not commensurate with the practice of
"evidence-based medicine". Today, world over, a need has been felt on
the imperative for transparency, accountability and accessibility in order to
re-establish public trust in clinical trial data. And this would be feasible
only if all clinical trials conducted are registered in a centralized clinical
trials registry. Registration of trials will ensure transparency, accountability
and accessibility of clinical trials.
The Clinical Trials
Registry- India (CTRI), hosted at the ICMR’s National Institute of Medical
Statistics (NIMS), is a free and online public record system for registration
of clinical trials being conducted in India that was launched on 20th
July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June
registration in the CTRI has been made mandatory by the Drugs Controller
General (India) (DCGI) (www.cdsco.nic.in).
Moreover, Editors of Biomedical
Journals of 11 major journals of India declared that only registered trials
would be considered for publication1, 2.
researcher who plans to conduct a trial involving human participants, of 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/)
is expected to register the trial in the CTRI before enrollment of the first
participant. Trial registration involves public declaration and identification
of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of
Ethics approval and DCGI approval (if applicable) is essential for trial
registration in the CTRI. Multi-country trials, where India is a participating
country, which have been registered in an international registry, are also
expected to be registered in the CTRI. In the CTRI, details of Indian
investigators, trial sites, Indian target sample size and date of enrollment
are captured. After a trial is registered,
trialists are expected to regularly update the trial status or other aspects as
the case may be. After a trial is registered, all updates and changes will be
recorded and available for public display.
a Primary Register of the International Clinical Trials Registry Platform
(ICTRP) (http://www.who.int/ictrp/search/en/), registered trials are freely searchable both from the
WHO’s search portal, the ICTRP as well as from the CTRI (www.ctri.nic.in).
mission of the Clinical Trials Registry-India (CTRI) is to encourage all
clinical trials conducted in India to be prospectively registered, i.e. before
the enrolment of the first participant.
While the mission
of the CTRI is to encourage all clinical trials conducted in India to be
prospectively registered before the enrollment of the first participant
currently, trials where patient recruitment has started or even completed are
also being registered. Post-marketing surveillance studies as well as BA/BE
trials are also expected to be registered in the CTRI.
vision of the CTRI is to ensure that every clinical trial conducted in the
region is prospectively registered with full disclosure of the trial data set
items. While this register is meant primarily for trials conducted in India,
the CTRI will also accept registration of trials conducted in other countries
in the region, which do not have a Primary Registry of its own.
registered in CTRI will be monitored to ensure increasing voluntary disclosure
of all items in the register. These items have been selected in order to:
Improve transparency and
accountability3: By disclosing all required details of the protocol of
trials, public confidence in clinical trials is likely to be enhanced.
Improve the internal validity of
trials: Empirical research has shown that
some aspect of the methods of the trial are particularly important to produce
reliable results by minimizing biases, confounders and the effects of chance or
coincidence. These include the method of random sequence generation, adequate
concealment of allocation of participants to interventions, adequate blinding
of participants, investigators and outcome assessors, and inclusion of all
participants' results4, 5. The CTRI hopes that these items, though
not mandatory at present, will be disclosed by all registrants, as
incorporating such elements at the protocol stage is likely to increase the
internal validity of the trial and also increase the chances of publication in
a high impact journal that endorses the ICMJE requirement of reporting trials
in accordance with the CONSORT statement6, 7.
Conform to accepted ethical
standards: The Indian Council of Medical
Research through its Bio-ethics initiative has developed ethical guidelines for
the conduct of trials and for ethics committees8. Clearance by local
ethics committees is mandatory for all clinical trials and the CTRI hopes that
making disclosure of ethical clearance a mandatory field for registration, it
will lead to better links with the ICMR's bio-ethics initiative.
Reporting of all relevant results of
registered trials: The CTRI is working with the WHO
ICTRP to ensure that results of all trials registered with the CTRI are
adequately reported and publicly available.
A, Aggarwal AR, Seth SD, Maulik, M, Bano R. Juneja A. Clinical Trials
Registry – India: Redefining the conduct of clinical trials. Indian J
Cancer 2008; 45 (3): 79-82.
- Pandey A,
Aggarwal A, Maulik, M, Seth SD. Clinical trial registration gains momentum
in India. Indian J Med Res [Letter to Editor] 2009; 130: 85-86.
- Pandey A,
Aggarwal AR, Seth SD, Maulik, M. Clinical Trials Registry – India: Raising
the veil. Natl Med J India [Letter
to Editor]2010; 23 (3):187 -188.
- Schulz KF, Chalmers I, Hayes
RJ, Altman D. Empirical evidence of bias. Dimensions of methodological
quality associated with estimates of treatment effects in controlled
clinical trials. JAMA 1995; 273:408-12.
- Jüni P, Altman DG, Egger M.
Assessing the quality of controlled clinical trials. BMJ 2001; 323: 42-6.
- Altman DG, Schulz KF, Moher D
for the CONSORT Group. The revised CONSORT statement for reporting
randomized trials: explanation and elaboration. Ann Intern Med 2001; 134:
- International Committee of
Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted
to Biomedical Journals. Available at http://www.icmje.org.
- Indian Council of Medical
Research. Ethical Guidelines for Biomedical Research on Human Subjects.
New Delhi: Indian Council of Medical Research, 2000.