|Year : 2023 | Volume
| Issue : 1 | Page : 45-46
Profile of clinical trials registered as a medical postgraduate research thesis, 2007 to 2019: Lessons for capacity building
Janana Priya Gunasekaran1, Raginee Dongre2, Sri Madhupriya Mahendiran3, Mohan Kumar Raju4, Manickam Ponnaiah4
1 Department of Public Health, ICMR-National Institute of Epidemiology, Chennai, Tamil Nadu, India
2 Divisional Coordinator-MNBC (Maternal and Newborn Care), Department of Public Health, Tribhuvan das foundation, Anand, Gujarat, India
3 Department of Public Health, Evidencian Research Associates, Bengaluru, Karnataka, India
4 Department of Epidemiology, ICMR-National Institute of Epidemiology, Chennai, Tamil Nadu, India
|Date of Submission||31-Oct-2021|
|Date of Acceptance||28-May-2022|
|Date of Web Publication||21-Dec-2022|
Dr. Mohan Kumar Raju
ICMR-National Institute of Epidemiology, R-127, TNHB, Ayapakkam, Chennai - 600 077, Tamil Nadu
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Gunasekaran JP, Dongre R, Mahendiran SM, Raju MK, Ponnaiah M. Profile of clinical trials registered as a medical postgraduate research thesis, 2007 to 2019: Lessons for capacity building. Perspect Clin Res 2023;14:45-6
|How to cite this URL:|
Gunasekaran JP, Dongre R, Mahendiran SM, Raju MK, Ponnaiah M. Profile of clinical trials registered as a medical postgraduate research thesis, 2007 to 2019: Lessons for capacity building. Perspect Clin Res [serial online] 2023 [cited 2023 Feb 1];14:45-6. Available from: http://www.picronline.org/text.asp?2023/14/1/45/364696
| Introduction|| |
Postgraduate (PG) research helps students develop the scientific and ethical principles in research and enhance their ability to generate novel information. Although the National Medical Council has made PG research mandatory, it is often criticized in terms of methodological flaws. Being the best study designs for generating evidence in health care, clinical trials have inherent challenges, including writing proposals, generating funds, and following ethical principles. To implement successfully, the major responsibilities lie on the principal investigator(s). As a beginner in clinical trials, PGs often lack the required knowledge and skills to execute these mandates. As a part of the regulatory approaches, India launched the Clinical Trial Registry of India (CTRI) in 2007 to ensure that all clinical trials conducted in India, including those conducted by the PGs, are prospectively registered with full disclosure of the trial data set items. Analysis and characterization of these clinical trials undertaken by the PGs may help in identifying the areas in need of interventions. In this regard, we described the clinical trials registered as PG thesis (PG trials) by type, time, and location.
| Materials and Methods|| |
We abstracted data related to each trial (year of registration, PG thesis, type of trial, study design, trial phase, primary sponsor, health type, and state of origin) from the CTRI website from 2007 to 2019. We carried out descriptive statistics using SPSS version 21.0. (IBM Corp, Armonk, NY).
| Results|| |
We identified 7850 clinical trials registered in the CTRI during 2007–2019, out of which 3289 (42%) were registered as PG thesis. By 2019, the PG trials have inflated by 6.8 times since 2016 (n = 189). However, the absolute number of multicentric/multicountry trials did not show any prominent rise. Most of the trials were interventional (96.5%, n = 3174), randomized (82%, n = 2701), and phase 2 trials (15%, n = 483). The major primary sponsors are the research institutions (37%, n = 1214) and the Government Medical Colleges (21%, n = 689). The number of PG thesis is substantially less in the East and the North-East zone of the country when compared to the northern and southern zone (Delhi, Chandigarh, Karnataka, Tamil Nadu, and Pondicherry). Furthermore, these five states together received around 80% of sponsorship from research institutions. Among the trials sponsored by the Government Medical Colleges, Delhi and Tamil Nadu alone received 41% (n = 281) sponsorship. Sponsorship given by the pharmaceutical industries and the government funding agencies constituted 1.8% of the PG trials. PGs often choose higher-level study designs such as randomized controlled trials (82.5%, n = 1338) when compared with other simpler trial designs such as single-arm trials (14.1%, n = 229) or nonrandomized trials (1.6%, n = 26).
| Discussion|| |
Our finding indicates that the number of clinical trials by PGs has increased markedly in the past 3 years. However, the geographical distribution identified that almost three-fourths of the PG trials are clustered in the North, South, and West zones states/UTs and lacks in East and North-Eastern zones. This might be contributed to the difference in the absolute number of PG seats across the states or the lack of infrastructural requirements and trained human resources with Good Clinical Practice for clinical trials.
A previous study has shown that PGs are often involved in a wide range of clinical trials that include interventional trials, drug trials, procedural interventions, and trials involving traditional medicines. We found that most of the thesis was randomized, involving human participants, and interventional. Clinical trials require advanced level of training that should cover at least the fundamental concepts of research methodology, ethical issues in clinical trials, country-specific regulatory requirements, and data handling. As a strategic step, the Board of Governors, has recommended a mandatory, uniform, online research methodology course called "Basic Course in Biomedical Research" for all PGs from the academic year 2019 to 2020.
Although the increasing PG trials trend is an excellent opportunity to foster clinical trials in India, funding for these may be inadequate. Hence, the medical institutions must develop institutional corpus funds, in addition to grants such as the Indian Council of Medical Research's research grants. At the institutional level, we strongly recommend the availability of a few support systems such as registered institutional ethics committees, clinical epidemiology department to support in developing the proposals, institutional corpus funds to meet the expense in conducting trials, and mentorship support to improve the research quality.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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