Identifier
Created
Classification
Origin
07NEWDELHI3813
2007-08-21 11:10:00
UNCLASSIFIED//FOR OFFICIAL USE ONLY
Embassy New Delhi
Cable title:
INDIA LAUNCHES ITS OFFICIAL CLINICAL TRIALS REGISTRY
how-toVZCZCXRO5608 RR RUEHHM RUEHLN RUEHMA RUEHPB RUEHPOD DE RUEHNE #3813/01 2331110 ZNR UUUUU ZZH R 211110Z AUG 07 FM AMEMBASSY NEW DELHI TO RUEHC/SECSTATE WASHDC 7714 RUEHIL/AMEMBASSY ISLAMABAD 3835 RUEHKA/AMEMBASSY DHAKA 0467 RUEHKT/AMEMBASSY KATHMANDU 0943 RUEHCI/AMCONSUL KOLKATA 0697 RUEHCG/AMCONSUL CHENNAI 1244 RUEHBI/AMCONSUL MUMBAI 0385 RUEHKP/AMCONSUL KARACHI 8086 RUEHLH/AMCONSUL LAHORE 4102 RUEHGV/USMISSION GENEVA 7195 RUEHPH/CDC ATLANTA GA RUEAUSA/DEPT OF HHS WASHDC RUEHRC/DEPT OF AGRICULTURE WASHDC RUCPDOC/DEPT OF COMMERCE WASHDC RUEAIIA/CIA WASHDC RHEFDIA/DIA WASHDC RUEHZN/ENVIRONMENT SCIENCE AND TECHNOLOGY COLLECTIVE
UNCLAS SECTION 01 OF 03 NEW DELHI 003813
SIPDIS
HHS FOR OGHA STEIGER/HICKEY/VALDEZ
CDC FOR BLOUNT/COX/EBERHARD
NIH FOR GLASS/HILEMAN/HANDLEY
OES/PCI FOR STEWART
OES/IHA FOR SINGER
FDA FOR LUMPKIN/WELCH
USAID FOR DENNIS CARROLL
SENSITIVE
SIPDIS
E.O. 12958: N/A
TAGS: TBIO TSPL ECON KSCA IN
SUBJECT: INDIA LAUNCHES ITS OFFICIAL CLINICAL TRIALS REGISTRY
NEW DELHI 00003813 001.2 OF 003
UNCLAS SECTION 01 OF 03 NEW DELHI 003813
SIPDIS
HHS FOR OGHA STEIGER/HICKEY/VALDEZ
CDC FOR BLOUNT/COX/EBERHARD
NIH FOR GLASS/HILEMAN/HANDLEY
OES/PCI FOR STEWART
OES/IHA FOR SINGER
FDA FOR LUMPKIN/WELCH
USAID FOR DENNIS CARROLL
SENSITIVE
SIPDIS
E.O. 12958: N/A
TAGS: TBIO TSPL ECON KSCA IN
SUBJECT: INDIA LAUNCHES ITS OFFICIAL CLINICAL TRIALS REGISTRY
NEW DELHI 00003813 001.2 OF 003
1. (U) Summary. India is rapidly emerging as an attractive
destination for clinical research. The need to ensure transparency,
accountability and accessibility of clinical trial data has
galvanized India to launch its official clinical trials registry.
This initiative, christened as the Clinical Trials Registry - India
(CTRI),aims to ensure that every clinical trial, conducted in India
and involving human participants, of any intervention is
prospectively registered. The CTRI's disclosure dataset has been
modeled on the recommendations of World Health Organization's
International Clinical Trials Registry Platform (WHO ICTRP). India
expects CTRI to become an associate member of the WHO ICTRP,
transforming it into a regional registry. At present, registration
of clinical trials with the CTRI is purely voluntary. With the
advent of CTRI, no changes are envisaged for USG and US
industry-supported clinical trials that are ongoing. However,
registration needs to be considered for all new US supported
clinical trials. This is a step towards improving transparency and
increasing public trust in the conduct of clinical research.
India's Need to Set Up the CTRI
--------------
2. (U) With India rapidly emerging as a strong contender in the
global clinical research industry, the need to ensure transparency,
accountability and accessibility of clinical trial data has become
increasingly significant. Through the initiative of India's Ministry
of Health (MOH),the National Institute of Medical Statistics (NIMS)
of the Indian Council of Medical Research (ICMR) has set up the
CTRI. Commenting on its launch, ICMR's Director General Professor
N. K. Ganguly said "with the launch of the CTRI, India is among the
select countries such as Australia, the United Kingdom, and the US
that will ensure researchers are accountable through registration
and public disclosure of clinical trials."
Bio-Medical Publishing Industry Driving Trial Registration
-------------- --------------
3. (U) Registration of clinical trials is now becoming a
pre-requisite for their publication in reputed medical journals. In
2005, the International Committee of Medical Journal Editors (ICMJE)
- a group of high profile medical journals - initiated a policy that
its journals would not accept papers reporting clinical studies that
had not been included in an authorized register before the onset of
patient enrollment. Subsequently, several other medical journals
have adopted this policy. Through the CTRI launch, India looks to
comply with this requirement and thus strengthen the publishing
ability of its clinical researchers.
Funding for CTRI
--------------
4. (U) NIMS has set up the CTRI with funding support from the GOI's
Department of Science and Technology (DST) through the ICMR. The
CTRI also receives financial and technical support through the WHO,
WHO South-East Asia Regional Office (WHO SEARO),and the WHO India
Country office.
Important Aspects of the CTRI
--------------
5. (U) India in its official communication states that the CTRI
aims to ensure that every clinical trial, conducted in India and
involving human participants, of any intervention (drug, surgical
procedure, preventive measures, lifestyle modifications, devices,
educational or behavioral treatment, rehabilitation strategies and
complementary therapies) is prospectively registered (that is,
NEW DELHI 00003813 002.2 OF 003
before the enrollment of the first patient).
6. (U) At present, registration of clinical trials with the CTRI is
free and purely voluntary. Besides the 20 items recommended by the
WHO International Clinical Trials Registry (WHO ICTRP),a
prospective registrant is also required to disclose information
regarding a few additional India-specific items, such regulatory
clearance from Drugs Controller General of India (DCGI),name of
ethics committee and approval status, etc. The CTRI will encourage
regular updates from registrants on protocol amendments and trial
status.
7. (U) It is being hoped that CTRI will serve as a primary registry
for the WHO ICTRP. It will collect disclosure dataset on all
clinical trials to be undertaken in India and make this information
available to the public. The plan is to make the CTRI a freely
available and a searchable primary registry.
CTRI Hopes to Become a Regional Player
--------------
8. (U) India expects CTRI to become an associate member of the WHO
ICTRP, transforming it from a national to a regional registry.
India will allow researchers from neighboring countries such as Sri
Lanka, Nepal, Bangladesh, Bhutan and Pakistan to register their
trials with the CTRI.
India Makes no Mention of US Registry Initiatives
-------------- --------------
9. (SBU) Interestingly, India has adopted clinical trial disclosure
dataset in line with WHO recommendations. This is despite the fact
that ClinicalTrials.gov has been the first initiative ever where
clinical trials could be registered. This was developed by NIH's
National Library of Medicine (NLM). Over the years,
ClinicalTrials.gov and other registries have been providing updated
information about research in human volunteers, for both federally
and privately supported clinical trials. US-India bilateral
collaboration has included a series of workshops on clinical
research aimed to update skill-sets in this sunshine area. This
series is ongoing with funding by the NIH Office of AIDS Research
(OAR). In October 2006, the technical architect of
ClinicalTrials.gov, NLM, Nick Ide made a presentation in India as a
part of this collaboration. (Note: India has always been edgy on
being associated in print on good ideas derived from US initiatives.
End Note.)
Pharmaceutical and Biotech Industry Apprehensions
-------------- --------------
10. (U) Pharmaceutical and biotech industry has suggested that a
so-called "lockbox" provision be included for certain registration
data items. This will serve to block access to information that
industry considers proprietary and that would be divulged through
public disclosure. In general, the industry would like to defer
public disclosure of certain details, such as description of the
intervention, target sample size, and primary and key secondary
outcomes, until the product is approved for the intended
indication.
Implications for USG and US Industry-Supported Trials
-------------- --------------
11. (U) With the setting up of the CTRI, no changes are envisaged
for USG and US industry-supported clinical trials that are ongoing.
However, CTRI registration needs to be considered for all new US
NEW DELHI 00003813 003.2 OF 003
supported clinical trials.
12. (U) The advent of CTRI and the public accessibility to clinical
trial data should promote greater public confidence in clinical
trials in India.
WHITE
SIPDIS
HHS FOR OGHA STEIGER/HICKEY/VALDEZ
CDC FOR BLOUNT/COX/EBERHARD
NIH FOR GLASS/HILEMAN/HANDLEY
OES/PCI FOR STEWART
OES/IHA FOR SINGER
FDA FOR LUMPKIN/WELCH
USAID FOR DENNIS CARROLL
SENSITIVE
SIPDIS
E.O. 12958: N/A
TAGS: TBIO TSPL ECON KSCA IN
SUBJECT: INDIA LAUNCHES ITS OFFICIAL CLINICAL TRIALS REGISTRY
NEW DELHI 00003813 001.2 OF 003
1. (U) Summary. India is rapidly emerging as an attractive
destination for clinical research. The need to ensure transparency,
accountability and accessibility of clinical trial data has
galvanized India to launch its official clinical trials registry.
This initiative, christened as the Clinical Trials Registry - India
(CTRI),aims to ensure that every clinical trial, conducted in India
and involving human participants, of any intervention is
prospectively registered. The CTRI's disclosure dataset has been
modeled on the recommendations of World Health Organization's
International Clinical Trials Registry Platform (WHO ICTRP). India
expects CTRI to become an associate member of the WHO ICTRP,
transforming it into a regional registry. At present, registration
of clinical trials with the CTRI is purely voluntary. With the
advent of CTRI, no changes are envisaged for USG and US
industry-supported clinical trials that are ongoing. However,
registration needs to be considered for all new US supported
clinical trials. This is a step towards improving transparency and
increasing public trust in the conduct of clinical research.
India's Need to Set Up the CTRI
--------------
2. (U) With India rapidly emerging as a strong contender in the
global clinical research industry, the need to ensure transparency,
accountability and accessibility of clinical trial data has become
increasingly significant. Through the initiative of India's Ministry
of Health (MOH),the National Institute of Medical Statistics (NIMS)
of the Indian Council of Medical Research (ICMR) has set up the
CTRI. Commenting on its launch, ICMR's Director General Professor
N. K. Ganguly said "with the launch of the CTRI, India is among the
select countries such as Australia, the United Kingdom, and the US
that will ensure researchers are accountable through registration
and public disclosure of clinical trials."
Bio-Medical Publishing Industry Driving Trial Registration
-------------- --------------
3. (U) Registration of clinical trials is now becoming a
pre-requisite for their publication in reputed medical journals. In
2005, the International Committee of Medical Journal Editors (ICMJE)
- a group of high profile medical journals - initiated a policy that
its journals would not accept papers reporting clinical studies that
had not been included in an authorized register before the onset of
patient enrollment. Subsequently, several other medical journals
have adopted this policy. Through the CTRI launch, India looks to
comply with this requirement and thus strengthen the publishing
ability of its clinical researchers.
Funding for CTRI
--------------
4. (U) NIMS has set up the CTRI with funding support from the GOI's
Department of Science and Technology (DST) through the ICMR. The
CTRI also receives financial and technical support through the WHO,
WHO South-East Asia Regional Office (WHO SEARO),and the WHO India
Country office.
Important Aspects of the CTRI
--------------
5. (U) India in its official communication states that the CTRI
aims to ensure that every clinical trial, conducted in India and
involving human participants, of any intervention (drug, surgical
procedure, preventive measures, lifestyle modifications, devices,
educational or behavioral treatment, rehabilitation strategies and
complementary therapies) is prospectively registered (that is,
NEW DELHI 00003813 002.2 OF 003
before the enrollment of the first patient).
6. (U) At present, registration of clinical trials with the CTRI is
free and purely voluntary. Besides the 20 items recommended by the
WHO International Clinical Trials Registry (WHO ICTRP),a
prospective registrant is also required to disclose information
regarding a few additional India-specific items, such regulatory
clearance from Drugs Controller General of India (DCGI),name of
ethics committee and approval status, etc. The CTRI will encourage
regular updates from registrants on protocol amendments and trial
status.
7. (U) It is being hoped that CTRI will serve as a primary registry
for the WHO ICTRP. It will collect disclosure dataset on all
clinical trials to be undertaken in India and make this information
available to the public. The plan is to make the CTRI a freely
available and a searchable primary registry.
CTRI Hopes to Become a Regional Player
--------------
8. (U) India expects CTRI to become an associate member of the WHO
ICTRP, transforming it from a national to a regional registry.
India will allow researchers from neighboring countries such as Sri
Lanka, Nepal, Bangladesh, Bhutan and Pakistan to register their
trials with the CTRI.
India Makes no Mention of US Registry Initiatives
-------------- --------------
9. (SBU) Interestingly, India has adopted clinical trial disclosure
dataset in line with WHO recommendations. This is despite the fact
that ClinicalTrials.gov has been the first initiative ever where
clinical trials could be registered. This was developed by NIH's
National Library of Medicine (NLM). Over the years,
ClinicalTrials.gov and other registries have been providing updated
information about research in human volunteers, for both federally
and privately supported clinical trials. US-India bilateral
collaboration has included a series of workshops on clinical
research aimed to update skill-sets in this sunshine area. This
series is ongoing with funding by the NIH Office of AIDS Research
(OAR). In October 2006, the technical architect of
ClinicalTrials.gov, NLM, Nick Ide made a presentation in India as a
part of this collaboration. (Note: India has always been edgy on
being associated in print on good ideas derived from US initiatives.
End Note.)
Pharmaceutical and Biotech Industry Apprehensions
-------------- --------------
10. (U) Pharmaceutical and biotech industry has suggested that a
so-called "lockbox" provision be included for certain registration
data items. This will serve to block access to information that
industry considers proprietary and that would be divulged through
public disclosure. In general, the industry would like to defer
public disclosure of certain details, such as description of the
intervention, target sample size, and primary and key secondary
outcomes, until the product is approved for the intended
indication.
Implications for USG and US Industry-Supported Trials
-------------- --------------
11. (U) With the setting up of the CTRI, no changes are envisaged
for USG and US industry-supported clinical trials that are ongoing.
However, CTRI registration needs to be considered for all new US
NEW DELHI 00003813 003.2 OF 003
supported clinical trials.
12. (U) The advent of CTRI and the public accessibility to clinical
trial data should promote greater public confidence in clinical
trials in India.
WHITE