ABSTRACT
CONTEXT: The elderly in India form a heterogeneous subset of the population with significant disease burden variations. However, there are no data available regarding the type of research studies conducted in an elderly population in India. AIMS: The aim of this study was to analyze the research studies conducted in the elderly population in India based on data from the Clinical Trials Registry of India (CTRI). SETTINGS AND DESIGN: This was an "audit" of available data on the CTRI website. PARTICIPANTS AND METHODS: Following exemption from the Institutional Ethics Committee, all studies in the elderly population registered in CTRI from its inception (July 2007 to August 2019) were reviewed. Data captured with respect to geographical distribution, study designs used, therapy area, trial registration, and funding. STATISTICAL ANALYSIS USED: The variables were analyzed using descriptive statistics using SPSS version 16.0. RESULTS: Out of a total of 21,400 studies in CTRI, a total of 99 (0.46%) studies involved only elderly patients. Of these studies, 60 (60.6%) were interventional, whereas 39 (39.4%) were observational. Of all the interventional studies, 17 (28%) tested drugs, 26 (43%) tested a lifestyle intervention, and the rest were nutraceuticals, Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy, and physiotherapy. Postgraduate theses constituted 60 (60.6%) studies. Eighty-seven (87.9%) were academic projects, eight (8.1%) were government-funded studies, and only four (4%) were pharmaceutical-sponsored studies. The most commonly studied therapy area was the central nervous system, followed by community medicine and orthopedics. CONCLUSIONS: This study depicts the underrepresentation of the geriatric population in clinical studies.
ABSTRACT
BACKGROUND AND OBJECTIVES: Artificial intelligence (AI) as a field has recently gained a lot of importance and is expected to revolutionize the health-care scenario in the near future. There have been no studies done worldwide to review the status of research with respect to the use of AI in health care. Hence, we conceptualized this study to get an overview of the clinical studies being conducted in the field of AI, by analyzing those registered on the Food and Drug Administration trial registry website. METHODOLOGY: All the clinical studies conducted in the field of AI registered on the ClinicalTrials.gov website up to September 2019 were reviewed and analyzed. The variables such as geographical distribution, study design, status of study whether ongoing or completed, therapy area, type of intervention tested, type of funding, and year of initiation of study were recorded. The data were analyzed using descriptive statistics using SPSS for Windows, Version 16.0 (SPSS Inc. Chicago, IL, USA). RESULTS: Out of all the studies registered, 156 were related to AI. Of these 156 studies, 84 were interventional and 72 were observational. The most common therapy area under study was oncology with 26.3% studies, followed by cardiology, ophthalmology, psychiatry, and neurology. Devices comprised the most common intervention being studied, accounting to 34% of studies, followed by diagnostics which included 28% of studies. In the first 8 months of 2019 itself, 65 studies had been registered. CONCLUSION: The study revealed an increasing trend in the studies being conducted using AI techniques, with majority being conducted in the area of oncology, with medical devices being the most common intervention being tested.
ABSTRACT
CONTEXT AND AIMS: Pregnant women undergo physiological changes which influence the efficacy as well as safety of medications used. Very few drugs are tested and approved for medical conditions during pregnancy, and less pharmacokinetic data are available to form clinical treatment guidelines. There was no data available regarding the type of research studies conducted in pregnancy in India. Hence, we conducted this study to analyze the type of research studies in pregnancy registered in the Clinical Trials Registry of India (CTRI). SUBJECTS AND METHODS: Following exemption from review by the Institutional Ethics Committee, all studies in pregnant women registered in CTRI from its inception in July 2007 to June 2018 were reviewed. Data were captured with respect to geographical distribution, trimester of pregnancy, study designs used, therapy area, and funding. STATISTICAL ANALYSIS USED: The variables were analyzed using descriptive statistics using SPSS version 16.0. RESULTS: Out of a total of 14,911 studies in CTRI, a total of 285 (1.91%) studies involved pregnant women. Of these studies, 199 (69.8%) were interventional, whereas 86 (30.1%) were observational. Of all the interventional studies, 119 (60%) tested drugs, 47 (24%) tested a nondrug intervention, and the rest were nutraceuticals, Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy, and vaccines. Postgraduate theses constituted 140 (49.1%) studies, 79 (27.7%) were academic projects, 27 (9.4%) were government-funded studies, and only 16 (5.6%) were pharmaceutical-sponsored studies. The most commonly studied therapy area was anesthesia, followed by hypertension and induction of labor. CONCLUSIONS: This study depicts underrepresentation of pregnant women in clinical studies and more evidence needs to be generated with respect to drug safety and pharmacokinetics.
ABSTRACT
Delamanid is a nitro-dihydro-imidazooxazole compound which was developed by a Japanese company, Otsuka Holdings inc. and has shown in-vitro and in-vivo activity against drug resistant tuberculosis. The drug exerts its anti-mycobacterial activity by inhibition of mycolic acid biosynthesis, leading to defective cell wall formation ultimately leading to bacterial death. Following the promising results in Phase 2 trials, Delamanid received approval in European Union in 2014, following which it was also approved in Japan and Korea in the same year. It was approved in India recently in August, 2017. Though relatively well tolerated, there have been concerns due to QT prolongation associated with the use of Delamanid. WHO has currently recommended use of Delamanid in combination with optimized background regimen in patients with pulmonary TB (conditional recommendation). More data from clinical trials and observational studies is awaited regarding use of Delamanid in children, HIV co-infection, pregnant women and use in combination with Bedaquiline.
