Clinical
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
2009, trial
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 publication.
Today, any
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.
Being
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).
The
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 enrollment 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.
PG Thesis Registration
Trials being conducted as part of PG thesis should mention both student?s as well as Guide's name and full official address, including department. Co-guide name may also be included, if desired). Names should be included in Contact Person details after mutual agreement on division of responsibilities. Verification is sought by email from all trial Contact Persons, except the trial Registrant
Trials being conducted as part of PG thesis should mention both student?s as well as Guide's name and full official address, including department. Co-guide name may also be included, if desired). Names should be included in Contact Person details after mutual agreement on division of responsibilities. Verification is sought by email from all trial Contact Persons, except the trial Registrant
Copied as fair use from http://ctri.nic.in/Clinicaltrials/cont1.php
For frequently asked questions about CTRI registration, please visit http://ctri.nic.in/Clinicaltrials/faq.php
All the PG and PhD scholars of Ayurveda doing clinical studies must consider registering their works in CTRI for more authenticity of their works, in turn for evidence basis of Ayurveda and registration is not at all a complicated procedure. It is being practiced in IPGT & RA, GAU, Jamnagar.
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