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Viewing cable 07NEWDELHI3813, INDIA LAUNCHES ITS OFFICIAL CLINICAL TRIALS REGISTRY

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Reference ID Created Released Classification Origin
07NEWDELHI3813 2007-08-21 11:10 2011-08-26 00:00 UNCLASSIFIED//FOR OFFICIAL USE ONLY Embassy New Delhi
VZCZCXRO5608
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 
 
 
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