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Launch of the Indian Clinical Trial Registry
The Clinical Trial Registry -
India (CTRI), the first such initiative in Asia, was launched by Dr. N.K.
Ganguly, Director General, Indian Council of Medical
Research (ICMR) on 20th July 2007 at the ICMR Headquarters, New Delhi. The Registry
has been developed by ICMR in collaboration with the World Health
Organization and the Department of Science & Technology. The launch was
attended by Dr. S.J. Habayeb, WHO Representative to India, Mrs S.M Khan from the Department of Science
& Technology, Dr. M Venkateswarlu, Drug Controller General India, Dr. Arvind Pandey, Director National
Institute of Medical Statistics (ICMR), Dr. Vasantha Muthuswamy, Sr DDG
(ICMR) along with other scientists and dignitaries.
In
his welcome address, Dr. Pandey outlined the need for the Registry and the
process of its development. A unique identification number will be provided
by the registry which would be useful for identification and publication of
trial results. Dr. Habayeb released the first CTRI bulletin on this occasion.
In his remarks, he said that this effort will provide accountability,
transparency and information sharing among stakeholders. Clinical trial
registries already exists in countries like US, UK and Australia, with this
launch, India too has joined this global effort towards making clinical trials more transparent. He congratulated India
for this timely step of launching the CTRI.
Mrs
Khan joined the other dignitaries in emphasizing the need for a clinical
trails registry in India and lauded the team at ICMR for its efforts for
undertaking such an effort. She hoped that in coming time, the CTRI would
achieve its objective of becoming a Primary Register for South / South East
Asia. As a regulator, Dr. Ventakeswarlu expressed immense satisfaction on
establishment of the registry. He emphasized its usefulness to the regulator,
especially in absence of complete information on clinical trial and offered
all assistance for this important initiative.
Prof.
Ganguly traced the genesis of the project and express gratitude for the
support received from WHO and DST for this vital effort. He shared the
efforts at ensuring that the registry is managed by a neutral body, supported
by a Steering Committee, Technical Working Group and a Monitoring Committee.
The registry would strive to protect the interest of all sections including
researchers and community. He emphasized that clinical data may not be
publishable unless trails are registered. The function closed with a vote of
thanks by Dr. Muthusamy.
Features
of the Registry
The
CTRI is an online register of clinical trials being conducted in India. Any
researcher who plans to conduct a trial involving human participants, of any
intervention can register the trial in CTRI before enrolment of the first
participant. Registration is voluntary and free, but some fields are
mandatory for registration to proceed. All registered trials will be made
publicly available and the registry is searchable by anyone free of charge. The CTRI incorporates the 20 items endorsed by the WHO International Clinical Trials Registry Platform (WHO-ICTRP) (www.who.int/ictrp) and the International Committee of Medical Journal Editors (ICMJE) (www.icmje.org/).
The Indian Registry joins WHO’s
International Clinical Trials Registry Platform, a web site that
enables users to search a central database that contains the trial
registration data sets provided by Primary Registers. At present there are
three Primary Registers, one in the United States, one each in the UK and
Australia. Primary Registers accept direct registration of trials or from
partner registers (pharmaceutical company clinical trials registers, university
registers etc) and provide access to the 20 item data set from these trials
to the ICTRP database and the International Search Portal. It is hoped that
the CTRI will serve as a Primary Register of the WHO-ICTRP International
Search Portal and register trials to be undertaken in India and the South or
South East Asian Region. It is anticipated that the setting up of the
registry will pave the way for improved transparency and accountability and
lead to reporting of all relevant results of all clinical trials in India and
the region.
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