AI Article Synopsis
Article Abstract
Introduction: In 2019, the Central Drugs Standard Control Organization (CDSCO) introduced the New Drugs and Clinical Trials Rules 2019 (NDCTR), which separated the research guidelines for "Clinical Trials" and "Biomedical and Health Research." As a result, guidelines issued by were stated to apply to academic clinical trials (ACTs). This change is important because academic studies are crucial for scientific advancement and repurposing of approved drugs in health-care industry. However, conducting an ACT can pose challenges. We assessed the level of awareness, knowledge, and challenges faced by investigators. Our aim is to overcome some of these challenges and encourage more academic studies for the betterment of healthcare and scientific knowledge in India.
Methodology: The study was conducted in two phases after obtaining approval from the Institutional Ethics Committee (EC) of three tertiary care hospitals in Mumbai. In the first phase, the number of ACTs was assessed from the clinical trial registry India website, while the number of registered and re-registered ECs were assessed from the CDSCO website. The second phase involved assessing investigator awareness and knowledge about ACTs using a prevalidated questionnaire with a content validity index score of 0.93.
Results: In 2020, the highest numbers of studies were registered, with the highest numbers of registered and re-registered ECs from Maharashtra. All participants completed the questionnaire and were aware of the need to follow guidelines for clinical trials. Sixty-seven percent of participants knew that the guidelines for ACTs differed from those of sponsored clinical trials, but only 58% were aware of the exact definition of an ACT as per NDCTR, 2019. Eighty-five percent of participants knew who could initiate an ACT, but only 27% knew about the applicability of results of an ACT and 33% had in-depth knowledge about the required approvals, while only 10% knew the archival period. Although 71% of participants had knowledge about serious adverse event reporting, few answered in-depth questions correctly. Only 31 participants reported facing varied challenges.
Conclusion: To conduct ACTs effectively and contribute to healthcare and scientific advancement, it is crucial to enhance investigators' existing knowledge about ACTs.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679577 | PMC |
| http://dx.doi.org/10.4103/picr.picr_68_23 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Semi-parametric sensitivity analysis for trials with irregular and informative assessment times.
Biometrics
October 2024
Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City, UT 84108, United States.
Many trials are designed to collect outcomes at or around pre-specified times after randomization. If there is variability in the times when participants are actually assessed, this can pose a challenge to learning the effect of treatment, since not all participants have outcome assessments at the times of interest. Furthermore, observed outcome values may not be representative of all participants' outcomes at a given time.
View Article and Find Full Text PDFThe long-term impact of vaccine clinical research on national stakeholders involved: Experience from a low-income Country.
Hum Vaccin Immunother
December 2025
Clinical, Assessment, Regulatory and Evaluation Unit, International Vaccine Institute, Seoul, Republic of Korea.
Clinical trials are the most rigorous scientific and regulated method to investigate the safety and efficacy of vaccines or drugs in pre-licensure stage. Clinical trial design and implementation are complex, time-consuming and involves close engagement with country's regulatory authority, clinical trial sites, investigators, and the healthcare system. Over the past few decades, a significant number of clinical trials have been conducted in low- and middle-income countries (LMICs), particularly in resource-limited settings.
View Article and Find Full Text PDFSystematic Review and Meta-Analysis of Application of Ultrasound-Guided Thoracic Paravertebral Block in Clinical Surgical Treatment.
Ann Ital Chir
December 2024
Department of Anesthesiology, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, 317000 Taizhou, Zhejiang, China.
Aim: There is a lack of consensus regarding the efficacy of thoracic paravertebral block (TPVB) and erector spinae plane block (ESPB) for postoperative pain in randomized controlled trials (RCTs). The comparison of TPVB and ESPB was explored through a systematic review and meta-analysis (MA) of relevant RCTs.
Methods: A comprehensive search of relevant literature was conducted using databases such as PubMed, Embase, and MEDLINE, from 2019 to June 2024.
Drive Pressure-Guided Individualized Positive End-Expiratory Pressure in Traumatic Brain Injury Surgery: A Randomized Controlled Trial.
Ann Ital Chir
December 2024
Department of Anesthesiology, Institute of Anesthesia, Emergency and Critical Care, Northern Jiangsu People's Hospital Affiliated to Yangzhou University, 225002 Yangzhou, Jiangsu, China.
Aim: Intraoperative lung-protective ventilation strategies (LPVS) have been shown to improve lung oxygenation and prevent postoperative pulmonary problems in surgical patients. However, the application of positive end-expiratory pressure (PEEP)-based LPVS in emergency traumatic brain injury (TBI) has not been thoroughly explored. The purpose of this study is to evaluate the effects of drive pressure-guided individualized PEEP on perioperative pulmonary oxygenation, postoperative pulmonary complications, and recovery from neurological injury in patients with TBI.
View Article and Find Full Text PDFThe role of vorasidenib in the treatment of isocitrate dehydrogenase-mutant glioma.
Neuro Oncol
December 2024
Center For Neuro-Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts, USA.
Isocitrate dehydrogenase (IDH)-mutant gliomas are the most common malignant primary brain tumors in young adults. This condition imposes a substantial burden on patients and their caregivers, marked by neurocognitive deficits and high mortality rates due to tumor progression, coupled with significant morbidity from current treatment modalities. Although surgery, radiation therapy, and chemotherapy improve survival, these treatments can adversely affect cognitive function, quality of life, finances, employment status, and overall independence.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!