|Year : 2020 | Volume
| Issue : 4 | Page : 272-282
Clinical Trials Registry – India: A decadal perspective
Mendu Vishnu Vardhana Rao, Mohua Maulik, Atul Juneja, Tulsi Adhikari, Saurabh Sharma, Jyotsna Gupta, Yashmin Panchal, Neha Yadav
CTRI, ICMR-National Institute of Medical Statistics, New Delhi, India
|Date of Submission||13-Jan-2020|
|Date of Decision||17-Aug-2020|
|Date of Acceptance||18-Sep-2020|
|Date of Web Publication||14-Oct-2020|
Dr. Mendu Vishnu Vardhana Rao
ICMR-National Institute of Medical Statistics, New Delhi - 110 029
Source of Support: None, Conflict of Interest: None
OBJECTIVE: To present a descriptive analysis of the clinical studies registered in the Clinical Trials Registry – India (CTRI) and deduce its impact.
METHODS: We searched the CTRI databease for all registered clinical studies from July 20, 2007 to May 31, 2018. Extracted data were analyzed in three time periods i.e., Periods 1, 2, and 3 based on the major activities and milestones of the CTRI. In addition, comparative registrations of the various Primary Registries of the WHO were compiled and registration policy of Indian journals with regard to trial registration assessed.
RESULTS: A total of 20,160 clinical studies were submitted to the CTRI in the designated study period. Of the registered 14,341 clinical studies, 10,485 (76.3%) were interventional trials which were either regulatory (n = 2004), academic non-regulatory (n = 3855), or those conducted as part of PG thesis (n = 4626) trials. Regulatory trials registration numbers varied according to the Indian regulatory scenario. PG thesis trial registrations showed a steep rise, although unlike regulatory trials, these were mostly retrospective registrations. CTRI registration numbers were comparable to that in other Primary Registries. Instructions to authors of 48% indexed Indian journals made a mention of trial registration.
CONCLUSIONS: The CTRI has a strong global presence and has enhanced the transparency of regulatory trials as well as academic research particularly thesis-based work. The latter is expected to help improve standard of research and prevent repetitive research. Additional support from Indian journal editors by strict implementation of prospective registration is crucial for increasing compliance by researchers.
Keywords: Clinical trials, Clinical Trials Registry – India, primary registry CTRI
|How to cite this article:|
Rao MV, Maulik M, Juneja A, Adhikari T, Sharma S, Gupta J, Panchal Y, Yadav N. Clinical Trials Registry – India: A decadal perspective. Indian J Pharmacol 2020;52:272-82
|How to cite this URL:|
Rao MV, Maulik M, Juneja A, Adhikari T, Sharma S, Gupta J, Panchal Y, Yadav N. Clinical Trials Registry – India: A decadal perspective. Indian J Pharmacol [serial online] 2020 [cited 2020 Oct 26];52:272-82. Available from: https://www.ijp-online.com/text.asp?2020/52/4/272/298142
| » Introduction|| |
The beginning of the 21st Century saw the rapid rise of the clinical trial industry in India with expectations of it becoming a preferred global clinical research center by 2012. The diversity of population, accessibility of huge number of patients, and willingness to participate in trials were believed to be contributing factors. However, the scenario was marred by reports of deaths and unethical trials, triggering concerns about the safety of trial volunteers in the country. Around the same period, reports of suppression or partial disclosure of the information, obscuring of risks, and selective publication brought disrepute to global clinical trials as well.
To restore public trust in the conduct of trials, in 2005, the International Committee of Medical Journal Editors (ICMJE) announced comprehensive prospective trial registration. Cognizant of the benefits and potential of such a transparent system, a proposal to establish such a registry in India, was mooted as well. Subsequently, in 2007, the Clinical Trials Registry – India (CTRI) was set up at National Institute of Medical Statistics, Indian Council of Medical Research, New Delhi, India, under the aegis of the WHO. The primary aim was to provide clarity with regard to the clinical research enterprise in the country. In addition, it was also intended to provide a corrective system against positive results bias and selective reporting. Public awareness as well as participation in clinical trials was likely to be positively impacted. The CTRI (www.ctri.nic.in) was also envisaged as a training platform for the first time researcher and a potentially viable tool to help raise the standard of clinical research in the country. Hence, apart from regulatory trials, registration was also encouraged for observational as well as postgraduate thesis-based clinical research. In this article, we present a descriptive account of the clinical studies registered in the CTRI over the past 10 years as well as discuss influence on and of regulations and policies.
| » Methods|| |
Data extraction from Clinical Trials Registry – India
The characteristics of all studies registered in the CTRI (n = 14,341) were extracted from the database. Data (as provided by the registrants) were tabulated after appropriate collation as described below.
Data for the type of primary sponsor were captured under nine subheadings. However, for the purposes of this article, these were clubbed under three major subheadings, i.e., pharmaceutical industry (combined data of pharmaceutical industry-global and Indian pharmaceutical industry along with contract research organizations); government funding (comprising of research institution, research institution and hospital, government funding agency and government medical college); and private medical colleges and hospitals (includes private medical college and private hospital/clinic). Similarly, dataset items like study design, method of concealment, intervention type, and areas of research were reclassified after collation. For instance, probiotics were pooled with nutraceuticals, while physiotherapy (not including Yoga) and process of care changes were clubbed with surgical/anesthesia-based studies. Traditional systems of medicines included Ayurveda, Yoga, Unani, Siddha, and Homeopathic trials. Information regarding country of trial, phase of trial, study design, and blinding was also extracted and collated from the available drop down lists.
While the CTRI was launched in 2007, the software application was upgraded in March 2011 wherein additional drop-down lists were incorporated to streamline data collection. Studies registered prior to the software revision, wherein trial details that had not been updated by the registrants (despite repeated requests) were indicated as “missing data” and varied for the individual characteristic analyzed. Extracted data have been described for all clinical study registrations in the CTRI after excluding missing data. In addition, a subanalysis of interventional trials, regulatory trials, and PG thesis-based trials was also undertaken.
The data were further described in three time periods as described below.
Period 1 (n = 1492) included data of studies registered between July 20, 2007, and December 31, 2010. During this period, sensitization and dissemination activities were undertaken primarily for the pharmaceutical industry, regulatory authorities, and journal editors.
Period 2 (n = 4981) comprised of studies registered between January 1, 2011, and December 31, 2015. In this period, the CTRI software application was upgraded (March 2011) and made completely paperless with drop-down lists included wherever feasible. Further, during this stage, active advocacy and capacity building activities were undertaken with a focus on academia and ethics committees. In addition, an e-tutorial was developed for the convenience of the trial registrants (http://ctri.icmr.org.in/).
Period 3 (n = 7868) included studies registered between January 1, 2016, and May 31, 2018. During this period, processes were initiated to implement results disclosure and International Classification of Diseases, Tenth Revision (ICD-10) coding for health condition. Further, CTRI moved to only prospective trial registration from April 1, 2018. In addition, two new dataset elements (as per the WHO recommendation) were added to the CTRI dataset items [Box 1].
Number of registrations in the different primary registries
The number of registrations in the Primary Registries of the WHO's International Clinical Trials Registry Platform (ICTRP) was charted. The ICTRP is a WHO initiative that aims to make information about all clinical trials involving humans publicly available from a single portal. The ICTRP collects and displays the trial registration dataset items obtained from registries, including CTRI, which meet its criteria for content, quality and validity, accessibility, unique identification, technical capacity, and governance and administration. These registries are designated as Primary Registries and are recognized by the ICMJE.
For the total number of registrations in Primary Registries of the ICTRP, individual registries were searched and number of registrations extracted from respective registries on November 19, 2018.
Registration policy of Indian journals
Indian biomedical journals were screened to establish the extent of editorial support to clinical trial registration as described elsewhere The National Library of Medicine Catalogue was searched on September 7, 2018, using the search string “India (country of publication) AND currently indexed.” A list of 37 journals was retrieved and each journal was individually reviewed. Of these, there were nine journals which did not have their editorial office in India and were excluded. Three journals were excluded as they did not publish clinical trials. The “instructions for authors” were downloaded from each of these 25 journals' websites and were independently scrutinized by two reviewers for instructions regarding the requirement for trial registration and coded for clarity and completeness. In case of disagreement, final decision was reached by consensus. Further, the 11 Indian biomedical journals [Box 2] which resolved to consider publication of a trial only if registered prospectively were also reviewed.
Seven of these journals were included in the list of 25 journals screened above while four journals which were not indexed were separately reviewed and instructions for authors scrutinized as above taking the number of total journals scrutinized to 29. In addition, each of these 11 journals' table of contents were searched online for the year 2017 and 2018 (until November) to check for actual mention of registration number in published interventional trials. For those articles where the registration number was not mentioned in the abstract, the full text was reviewed for the same. Keyword search for “randomized controlled trials”; “RCT”; “clinical trial registry”; “CTRI” and “interventional” was made in both the archive and advanced search sections of each journal.
| » Results|| |
A total of 20,160 clinical studies were submitted to the CTRI for registration in the study period. Of these, 14,341 (71.1%) were registered [Figure 1] while 213 (1.1%) were new submissions as well as those resubmitted by registrants after modifications suggested by CTRI review team. Another 4951 (24.5%) studies were yet to be resubmitted after modifications by the registrants, while 655 (3.2%) were not registered due to noncompliance with CTRI requirements, such as no E-mail confirmation from trial investigators, non-submission of ethics or regulatory documents, etc.
|Figure 1: Status of 20160 clinical studies submitted to CTRI until 31st May 2018|
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Characteristics of registered in the Clinical Trials Registry – India (n = 14,341)
An increase in the registration rates was observed in the different time periods from 36 per month in Period 1 to 83 per month in Period 2 which further increased to 271 per month in Period 3. Interventional trials constituted the majority of registrations (10,485 [76.3%]) in all the three periods [Table 1]. Observational study registrations were 2698 (19.6%), while postmarketing surveillance and bioavailability/bioequivalence study registrations were 2.0% each. Regulatory study registration increased from 959 in Period 1 to 1187 in Period 2 and decreased to 557 in Period 3 out of a total of 2703 registrations. PG thesis registration increased from 50 in Period 1 to 1655 in Period 2 to 4391 in Period 3 out of a total of 6096 registrations.
Government-funded studies comprised 6272 (45.8%) of 13,707 and registration numbers showed a steady increase over the years. Pharmaceutical industry-sponsored studies increased from 670 in Period 1 to 1461 in Period 2 and then fell to 800 by Period 3 out of a total of 2931 [Table 1].
Multicountry trial registrations accounted for 1183 (8.3%) of 14341 and showed an apparent increase from 355 in Period 1 to 555 Period 2 and then a decrease to 273 in Period 3. However, per month registrations were similar in all three periods. During this period, the CTRI also registered 33 clinical studies from countries which had no Primary Registry of their own. Overall, about 40% of studies were prospectively registered, and showed a rising trend from 1762 in Period 2 to 3336 in Period 3 [Table 1].
Completeness of the registered studies in the Clinical Trials Registry – India
All 14,341, i.e., 100% studies registered reported the name of the Scientific Query and Public Query contact person including official address, E-mail address, phone numbers for the trial, as well as the study site. The interventional details and specifics like dosage were available for 99.8% of all registered interventional trials.
All (100%) registered interventional trials provided the primary outcome and secondary outcome details. However, a qualitative analysis of the provided information was not undertaken for any of the above characteristics.
Subanalysis of interventional trials (n = 10,485)
As interventional trials formed the bulk of registration, trends were similar to overall clinical studies' registrations [Table 2].
Over the years, there was a rise in the registration of drug trials from 584 in Period 1 to 1717 in Period 2 to 2086 in Period 3 out of 4387. Dental trial registration showed an increase from a registration of 6 (0.7%) trials out of 817 trials in Period 1 to 520 (9.1%) of 5742 trials in Period 3. Trial registration on traditional systems of medicine also showed a considerable rise from 24 (2.9%) of 817 trials in Period 1 to 1453 (25.3%) of 5742 trials in the Period 3. Phase 3 trials were 1917 (18.2%) followed by 1389 (13.2%) of Phase 2 and Phase 4 were 1125 (10.7%) of a total of 10485. With respect to trial design, most trials 7626 (73%) were randomized control trials. About one third of the trials were open labeled whereas the proportion of double-blinded trials were 2093 (20.3%) while 1606 (15.5%) were single-blinded out of a total of 10330 [Table 2].
Subanalysis of interventional regulatory trials (n = 2004)
A subanalysis was done on registered interventional regulatory trials, i.e., the trials approved by the licensing authority. These trials accounted for 2004 (14.0%) of 14341 total registered clinical studies [Table 3]. Others, such as BA/BE, postmarketing surveillance studies, were excluded from this analysis.
The number of registered regulatory trials increased 60% from 606 in Period 1 to 972 in Period 2 which was followed by a 30% decline to 426 in Period 3. Majority of the regulatory trials, 1707 (86.3%) of 1979 were sponsored by the pharmaceutical industry. A time period-wise analysis showed that the pharmaceutical-sponsored studies were similar in all the three periods although there was a slight increase in registration of regulatory trials conducted by government agencies, 24 trials in Period 1 to 40 trials in Period 3.
Overall, approximately half of the regulatory trials were multicountry trials. However, in Period 3, there was a remarkable decrease in the registration of multicountry trials to 151 [Table 3].
Regulatory trials were mostly drug trials 1467 (66.4%) followed by biological, 280 (12.6%); vaccine 213 (9.6%); preventive 58 (2.6%); and medical device trials 55 (2.4%) out of a total of 2004 trials. Majority of the registered regulatory trials were Phase 3 trials 1160 (57.8%) of 2004 which showed a steady decrease over the years from 395 in the Period 1 to 214 in Period 3. Predictably most of the regulatory approved trials were randomised controlled trials, 1514 (75.5%) of 2004 [Table 3].
Subanalysis of PG thesis trials (n = 4626)
Post-graduate thesis-based trials (including MD, MSc, PhD, DM etc.) constituted 4626 (44.1%) of 10485 interventional trials and showed a remarkable increase over the years [Table 4]. Most PG thesis trials were registered retrospectively i.e., 3208 (70.2%) out of a total of 4572.
The most common type of intervention in PG thesis trials were drugs 1864 (29.1%) followed by procedural interventions 1515 (23.7%) out of 4626 trials. There was a remarkable increase in the registration of trials in traditional systems of medicine in Period 2 (296 [22.3%] of 1325) over Period 1 (5 [11.4%] of 44) which further increased to 947 ([29.1%] of 3257) in Period 3.
Phase of trial was indicated as not applicable for approximately half (2278 [49.2%[ of 4626) PG thesis trials. Phase 2 trials were 610 (13.2%) followed by 461 (10.0%) Phase 4 and 394 (8.5%) Phase 3 trials of 4626 each [Table 4].
Number of registrations in primary registries
The number of registrations in each of the 16 Primary Registries of the ICTRP and their year of launch are shown in [Figure 2]. The earliest registry is the UK registry set up in the year 2000, followed by the Netherlands and EU registries in 2004. The Chinese registry was set up in 2005, followed by the Sri Lankan registry. In 2007, five registries, including the CTRI were launched while the others followed subsequently.
|Figure 2: Number registered in each of the Primary Registry (as per data extracted from respective sites on 19th Nov 2018)|
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Registration policy of Indian journals
Registration requirements were mentioned in the instructionstoauthors' section in 14 (48.3%) of 29 journals reviewed. Instructions to authors of the other 15 (51.7%) of 29 journals made no mention of trial registration. Review of the 11 Indian biomedical journals that had adopted the policy for trial registration, five (45.4%) journals made a mention of registration while the rest made no reference to it.
The original article section of 11 biomedical journals were screened for the year 2017 and a total of 24 interventional trials were identified (two journals did not publish any randomized controlled trial during this period) however, a registration number was mentioned in six (25.0%) of these articles. Similarly, the original article section of 11 biomedical journals were screened until November 2018, wherein a total of 12 randomized controlled trials were identified out of which registration number was mentioned in four (33.3%) articles.
| » Discussion|| |
The CTRI was set up with the aim of bringing transparency, fixing responsibility and developing a publicly accessible database of clinical research conducted in the country. The challenges encountered during the setting up of the CTRI and the strategies adopted to overcome these have been described elsewhere. In 2016, an audit of the CTRI data was carried out by independent researchers on CTRI data available in the public domain. However, in this article we present, for the first time, a descriptive analysis of the CTRI data extracted from the CTRI database.
The CTRI, with 14,341 registered clinical studies (until May 31, 2018), has come a long way since it was launched on July 20, 2007. The first clinical trial was registered in the CTRI after more than a month of its launch and by the end of the year there were a total 11 clinical trials registered. Initially only interventional trials were registered prospectively. However, in view of the growing request for trial registration and lack of awareness among researchers, particularly in the periphery, the CTRI opened up to retrospective registration. This was with the expectation that with time, prospective registration would become the norm. While regulatory studies (as mandated by the licensing authority) showed a rising trend in prospective registration, PG thesis-based trials were primarily registered retrospectively.
As per the Regulations of Medical Council of India, postgraduate/super-specialty courses (MD/MS/DNB/DM/M. Ch), thesis is an essential part of the degree courses. Undertaking thesis work is expected to inculcate an appreciation for research methodology and promote critical analysis. However, there are concerns that due to various reasons, such as lack of dedicated research time, under-staffed speciality departments, infrastructural and funding constraints, the quality of post graduate medical research is not up to the mark and is further plagued by repetitive research.,
According to a review published in 2016, only 25 (4.3%) of the institutions produced more than 100 papers a year but their contribution was 40.3% of the country's total research output.
Registration of PG thesis in the CTRI is one effective way of bringing these to the forefront providing valuable insight to the type and quality of research being done by post-graduate students. Further, it would also provide young researchers easy access to clinical research being conducted at other and own institutions. This would in turn help them develop better research proposals and avoid repetitive, possibly harmful research. However, in the absence of any regulatory mandate, suspicions and concerns of intellectual theft are hurdles to registration of academic trials.
In view of this, the CTRI has undertaken extensive advocacy and dissemination/training workshops in medical colleges. Special measures were taken to sensitize and garner the support of ethics committees as well. The efforts have had a demonstrable impact with a remarkable rise in the registration of PG theses-based research, albeit retrospectively. This is particularly applicable for Ayurveda trials (constituting 70% of registered traditional medicine trials) as researchers found that maximum registrations occurred in the states of Gujarat, Maharashtra and Karnataka where bulk of dissemination workshops were conducted.
The increase in registration of PG trials has also been attributed at least in part to publication hurdles. In 2008, at the behest of CTRI, Editors of 11 Indian Biomedical Journal had resolved to make prospective registration a precondition for publication. However, a review of Indian biomedical journals revealed that implementation of registration was far from satisfactory. The global scenario is also dismal with a reported 63.6% registration of randomised clinical trials even in international journals with a high-impact factor.
Further globally, unregistered trials continue to be conducted or are registered retrospectively. In addition, improperly registered trials are almost always published, suggesting that medical journal editors may not be actively enforcing registration. Interestingly, nonindustry-sponsored trials (including government-sponsored trials) are more likely to be unregistered or retrospectively registered.,
It may be noted that PG thesis trials registered with the CTRI are primarily government sponsored as in India most medical colleges are supported by the government. Although a rising trend in the registration of government-funded and investigator-initiated studies was observed in our analysis, there remains an overwhelming need to increase government funding for academic research. PG theses often report findings which are incomplete, inadequate and lack uniformity. Like other researchers, we have also observed that students do not have clear concepts regarding clinical trials. Outcome is often confused with results and interventional trials are labelled as observational along with mislabelling of trial phase. For instance, (about 42) observational PG thesis studies have been flagged as a Phase 1 trial.
Trial registration in the CTRI, particularly of PG thesis, is a valuable and as yet untapped resource which could help to redirect mundane repetitive research to more meaningful outcome-based research that is in sync with national health policies and requirements.,
There is an urgent need to advocate for the review of CTRI data as a potential resource for the development of meaningful research protocols as well as avoid repetitive work.
Unlike PG thesis trials, regulatory trials were primarily registered prospectively and were industry sponsored. Further, the registration pattern of these prospectively registered trials closely reflected the changing regulatory scenario in the country as shown in [Figure 3].
|Figure 3: Trial registration trend of regulatory trials over the years (until 31st May 2018). Data for trial status is not available for the years 2007 to 2010.|
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In the early years of the 21st century, India was poised to become a “clinical trial capital” of the world and simultaneously efforts were undertaken by the government in India to promote India as the preferred destination for conducting clinical trials. In 2005, the phase lag in clinical trials was done away with and concurrent phase trials allowed. But there were also growing instances of clinical trials being conducted without proper regulatory/ethical review. Patients were inducted into trials without being informed of being part of a research project or that other treatment options were available. Mechanisms for the protection of patient safety were not in place.
The CTRI was set up in this scenario when public trust in the conduct of clinical trials particularly by the industry was at an abysmal low. The CTRI slowly, but effectively, brought in transparency in clinical trials being conducted in the country. The substantial rise in registration is evidently responsive to national regulatory guidelines and rulings [Figure 3]. In 2009, when the licensing authority in India, announced mandatory prospective registration of regulatory trials, there was a remarkable increase in registration of industry-sponsored trials. However, when, in 2013, the Supreme Court of India barred clinical trials of new drugs until a proper safeguards and monitoring mechanisms were in place, there was a downward trend in the registration of industry-sponsored trials particularly multinational trials. In 2016, regulations, such as cap on number of trials a PI can conduct, trials restricted to hospitals with a minimum of 50-beds, compulsory audio-video recording of informed consent were relaxed.
This led to a revival of industry-sponsored regulatory trials; however, multicountry trials continue to lag behind possibly because of stringent compensation clauses. In addition to documenting regulatory trials, the CTRI has also highlighted irregularities as well as influenced regulatory changes.,
| » Conclusions|| |
The CTRI is possibly unique among other registries in actively promoting the registration of PG thesis-based studies. It is also one of the most significant achievements of CTRI. Nevertheless, innumerable opportunities remain for utilizing the registered data in a systematical manner to streamline development of PG thesis protocols, function as a learning tool, and raise standard of research as well as direct meaningful research that is in line with the country's public health issues. Further, in order to maximize its utility, implementation of results disclosure is of paramount importance. In keeping with this, the CTRI has initiated the development of a platform for the disclosure of structured summary results, which would enhance accessibility of clinical trial results particularly that which remains unpublished. Re-sensitization of journal editors may help to further promote prospective trial registration.
The authors acknowledge the technical inputs of Dr Ashok Sehgal, Consultant CTRI as well as the support provided by the following staff: Mr. Anoop Upadhyay, Mr. Bir Singh, Mr. Harish Kumar, Ms. Noori Dua, Ms. Deepty Rathi, and Mr. Din Bandhu in the initial screening of trials.
Financial support and sponsorship
The CTRI has been set up with financial support from the Indian Council of Medical Research, Ministry of Health and Family Welfare, Government of India; Department of Science and Technology, Government of India, and World Health Organization, India Office, New Delhi, India. The CTRI website is hosted by the National Informatics Centre Services Inc., New Delhi, India.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4]