ArticleIndian journal of anaesthesia2017
Regulatory requirements for clinical trials in India: What academicians need to know.
Article in Indian journal of anaesthesia, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed.
- Comparison of intranasal midazolam-fentanyl with dexmedetomidine-fentanyl as pre-medication in the paediatric age group.The Indian journal of medical research · 2023Trial
- Phase III Trials in India: A Comprehensive Analysis of the Clinical Trials Registry-India.Cureus · 2026Article
- Unlocking the probiotic potential of breast milk-derived lactobacillus against urinary tract infections: mechanisms, therapeutic prospects, and future directions.Antonie van Leeuwenhoek · 2026Review
- Article
- Knowledge and perceptions about clinical research and its ethical conduct among college students from non-science background: a representative nation-wide survey from India.BMJ public health · 2024Article
- Review
- Mental Health Research in India: New Challenges and the Way Forward.Indian journal of psychological medicine · 2022Article
- A cross-sectional questionnaire based study to assess and compare knowledge of drug schedules amongst healthcare professionals in a medical college.Medical journal, Armed Forces India · 2022Article
- Nationwide impact of COVID-19 pandemic on postgraduate medical teaching, research, and mental stress: A cross-sectional online questionnaire-based survey.Journal of anaesthesiology, clinical pharmacology · 2022Article
- What empirical research has been undertaken on the ethics of clinical research in India? A systematic scoping review and narrative synthesis.BMJ global health · 2021Article
- Aftermath of COVID-19: Wither postgraduate teaching and research?Indian journal of anaesthesia · 2020Article
- Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study.JMIR research protocols · 2020Article
- Issues, challenges, and the way forward in conducting clinical trials among neonates: investigators' perspective.Journal of perinatology : official journal of the California Perinatal Association · 2019Article
- The International Polycap Study-3 (TIPS-3): Design, baseline characteristics and challenges in conduct.American heart journal · 2018Article
- Clinical Trials Registry - India: A decadal perspective.Indian journal of pharmacologyArticle
- Comparison of Safety and Efficacy of Two Brands of Botulinum Toxin A for the Treatment of Lateral Canthal Lines (Crow's Feet): A Split-Face Study.Journal of cutaneous and aesthetic surgeryArticle
- Onsite serious adverse events reporting: Seven-year experience of the institutional ethics committee of a tertiary care hospital.Perspectives in clinical researchArticle
- Herbal medicaments in endodontics - Current guidelines forJournal of conservative dentistry : JCDReview
- Role of investigational new drug committees in propelling the drug development ecosystem in India.Perspectives in clinical researchArticle
- Investigator-initiated studies: Challenges and solutions.Perspectives in clinical researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. Of these, research, though long and difficult, is extremely fulfilling. Academicians often carry out research that is based on observations in practice or in response to their patient's needs. These are called as "Investigator- initiated studies" and these may not have the funding support of the pharmaceutical industry. Hence, the investigator must make sure that he/she complies with the country's regulatory requirements. In the past decade, several changes have dotted the regulatory landscape in the country and have changed the way in which academic research is carried out. The present article outlines regulatory requirements for academic research giving their historical evolution, the key bodies in India that govern or oversee research, along with "must know" and "good to know" facets for the conduct of clinical research in the country.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.