Perspectives in Clinical Research最新文献

{"title":"Ethics review of digital health research: Rethinking rights of participants.","authors":"Arun Bhatt, Deepa Chodankar","doi":"10.4103/picr.picr_68_26","DOIUrl":"10.4103/picr.picr_68_26","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"55-57"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171115/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical research in pediatric population: Scientific and ethical aspects.","authors":"Arun Bhatt","doi":"10.4103/picr.picr_144_25","DOIUrl":"10.4103/picr.picr_144_25","url":null,"abstract":"<p><p>Children are a unique population with important differences in physical, physiological, and emotional differences from adults. Hence, research outcomes of studies conducted in adults cannot be extrapolated to pediatric population. However, there is scarcity of data on the safety and efficacy of new interventions in children, due to concerns about risks of research in children. It is vital to conduct scientifically robust and ethically sound observational noninterventional studies and interventional therapy clinical trials in children to provide supporting evidence for medical practices in the pediatric population, to advance understanding of diseases, and to provide quality health care. This is a brief review of scientific and ethical considerations in planning and conduct of clinical research in children.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"65-70"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171113/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analyzing clinical trials on diabetic retinopathy: Insights from the Clinical Trials Registry - India.","authors":"M Vikram Balaji, Nivasini Natarajan Thangam, Arunkumar Ramaraj, R Jamuna Rani","doi":"10.4103/picr.picr_69_25","DOIUrl":"10.4103/picr.picr_69_25","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"121-122"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171133/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preparing for central drugs standard control organization ethics committee inspections in India: A review of regulatory expectations and readiness strategies.","authors":"Mrunalini Vinay Kalikar, Ganesh Dakhale","doi":"10.4103/picr.picr_395_25","DOIUrl":"10.4103/picr.picr_395_25","url":null,"abstract":"<p><p>The Central Drugs Standard Control Organization (CDSCO), the national regulatory authority for drugs and clinical trials in India, recently issued a comprehensive inspection checklist for ethics committees (ECs), dated 29 May 2025. This checklist aligns with the New Drugs and Clinical Trial Rules, 2019, and Indian Good Clinical Practice guidelines. Its release marks a significant step toward the standardization and accountability of ECs involved in clinical research. This review article critically examines the checklist and outlines strategies by which ECs in India can strengthen their structure, function, and preparedness in anticipation of CDSCO inspections.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"115-117"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171131/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patterns of adverse drug reactions and treatment outcomes in drug-resistant tuberculosis: A retrospective study from a tertiary care hospital in Delhi.","authors":"Amit Kamboj, Kshitij Agarwal, Rekha Rao, Minakshi Garg","doi":"10.4103/picr.picr_70_25","DOIUrl":"10.4103/picr.picr_70_25","url":null,"abstract":"<p><strong>Background: </strong>Multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant TB (XDR-TB) pose significant global health challenges with high mortality risks. Adverse drug reactions (ADRs) further complicate treatment, impacting patient adherence and outcomes. In India, the DOTS strategy under the Revised National Tuberculosis Control Programme has been widely implemented, yet TB management is hindered by limited patient awareness, socioeconomic constraints, and gaps in healthcare provider training. This study assesses the incidence of ADRs and their impact on treatment outcomes at a tertiary care hospital in Delhi.</p><p><strong>Materials and methods: </strong>A cross-sectional study was conducted using retrospective medical record reviews of MDR-TB and XDR-TB patients (aged ≥18 years) registered at a university hospital in Delhi from January 2017 to August 2021. Data on ADRs and treatment outcomes were extracted from outpatient records for analysis.</p><p><strong>Results: </strong>Of 213 enrolled patients, 183 were analyzed, with 72.6% experiencing at least one ADR. Males had a higher ADR incidence (58%) than females (42%). The most common ADRs were gastrointestinal disorders (21.8%), eye disorders (14.3%), and musculoskeletal disorders (14.3%), primarily linked to pyrazinamide, ethambutol, and ethionamide. Serious ADRs occurred in 17.4% of cases.</p><p><strong>Conclusion: </strong>Gastrointestinal disorders, particularly nausea and vomiting, emerged as the most commonly reported ADRs. These findings emphasize the importance of early identification of high-risk patients and the need for close monitoring throughout anti-TB treatment to support adherence and improve outcomes. This study adds valuable evidence to strengthen pharmacovigilance efforts and inform the optimization of MDR/XDR-TB treatment protocols within India's public healthcare system.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"71-76"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171125/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost analysis and drug utilization pattern in diabetic patients attending outpatient at tertiary care teaching hospital in South Gujarat.","authors":"Sajal Pandya, Chetna Patel, Ashvin Vasava, Brijesh Sojitra","doi":"10.4103/picr.picr_60_25","DOIUrl":"10.4103/picr.picr_60_25","url":null,"abstract":"<p><strong>Context: </strong>Diabetes is a global health concern, and effective glycemic control relies on the rational use of antidiabetic agents, which can be evaluated through drug utilization studies to ensure cost-effective pharmacotherapy.</p><p><strong>Aims: </strong>The aim of the study was to analyze the costs and drug utilization pattern in diabetic patients with the objectives of direct cost analysis of drugs, indirect cost analysis, and cost index. Measurement of WHO prescribing core indicators, patient care indicators, and facility indicators, prescribed daily dose (PDD)/defined daily dose (DDD) ratio.</p><p><strong>Settings and design: </strong>Participants were recruited from the Non-communicable disease and medicine OPD, and the study design was cross-sectional, observational, according to STROBE guidelines.</p><p><strong>Subjects and methods: </strong>The study began after institutional review board approval, with data collected from 250 participants following informed consent. A total of 1500 prescriptions were analyzed using appropriate parameters for cost analysis and WHO core drug use indicators. Drugs were categorized under anatomical, therapeutic, and chemical/DDD system, and the PDD/DDD ratio was calculated.</p><p><strong>Statistical analysis used: </strong>Descriptive statistics in Microsoft Excel 2021.</p><p><strong>Results: </strong>The study results found that the hospital covered most costs (481.1 INR per encounter), while participants bore 102.1 INR for anti-diabetic drugs and 234.35 INR in indirect costs monthly. An average of 2.68 antidiabetic drugs per prescription, with 95.60% prescribed by generic name and 33.46% involving injections. Metformin was the most prescribed drug (88.1%). A total of 12 drugs had a PDD/DDD ratio of 1.</p><p><strong>Conclusions: </strong>The study met WHO prescribing, patient care, and facility indicators, adherence to guidelines, and key drugs dispensed from the hospital pharmacy, reducing direct costs to the hospital pharmacy and participants.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 2","pages":"83-90"},"PeriodicalIF":0.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13171138/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of barriers and facilitators of remote data capturing and monitoring in decentralized clinical trials.","authors":"Namrata Dharmagonda Patil, Geetanjali S Salimath, Amaresh Kurubara","doi":"10.4103/picr.picr_293_25","DOIUrl":"10.4103/picr.picr_293_25","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 1","pages":"53-54"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900400/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146202201","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficiency and effectiveness of concise evidence-based medicine training program at a tertiary healthcare institute - Exploring the impact on research output of faculty.","authors":"Poorvi Kulshreshtha, Rajesh Kathrotia, Manisha Naithani, Puneet Dhamija, Manisha Bisht, Shalinee Rao","doi":"10.4103/picr.picr_33_25","DOIUrl":"10.4103/picr.picr_33_25","url":null,"abstract":"<p><strong>Background: </strong>Many clinicians fail to incorporate principles of evidence-based medicine (EBM) while treating patients due to a lack of formal training in EBM. Faculty/clinicians lacking expertise in EBM skills cannot promote evidence-based practice in their students and residents. The present study was conceived to evaluate the research aptitude as the output of structured training on EBM.</p><p><strong>Materials and methods: </strong>Retrospectively data generated from the intervention through a concisely structured 4-day training workshop on research methodology, biostatistics, and EBM module was analyzed on various parameters. The performance of participants was analyzed based on the post-test assessment data. Faculty research data output was based on the number and quality of scientific publications and the number of research projects a year before attending the training program and over the next 3 years after the intervention.</p><p><strong>Results: </strong>A total of 300 participants attended six successive training programs comprising 100 students (postgraduates and Ph. D) and 200 faculty. All participants scored satisfactorily in the post-test. Postintervention, there was a statistically significant increase in the number of publications and research projects by the faculty members as assessed by the Chi-square test (<i>P</i> < 0.001). Post-EBM training, research quality was transitioned from observational to randomized controlled trials, systematic reviews, and meta-analyses.</p><p><strong>Conclusion: </strong>A well-structured, short-duration course on EBM is a feasible option for efficient and effective training. Faculty showed consistent and statistically significant improvement in research output. Regular short-duration EBM courses pave the way for a culture of research in the Institute.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 1","pages":"27-32"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900414/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146202302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality of life in tuberculosis patients: A comparative study of video-observed therapy and directly observed therapy.","authors":"Vikas Chauhan, Khalid Umer Khayam, Sonal Setya","doi":"10.4103/picr.picr_9_25","DOIUrl":"10.4103/picr.picr_9_25","url":null,"abstract":"<p><strong>Purpose: </strong>Tuberculosis (TB) is a chronic disease that negatively impacts the quality of life (QoL) due to the physical, emotional, and social challenges it poses. Digital technology has transformed the management of TB by improving patient outcomes and enabling more efficient and personalized care. One such innovation, video-observed therapy (VOT), enables healthcare workers to observe the patient taking their medication in real-time via video call.</p><p><strong>Aim: </strong>This study aims to compare the impact of VOT and directly observed therapy (DOTs) on QoL in TB patients.</p><p><strong>Methods: </strong>This observational and prospective study was conducted at a TB hospital in India, for 6 months on 110 TB patients, with 55 each in VOT group and DOTs group. Ethical approval was obtained, and patients were provided with an information sheet before signing the consent form. Demographic data were collected, and QoL was assessed using SF-36 scale. Statistical analyses were performed using SPSS software, with ANOVA and <i>t</i>-tests employed to compare variables (<i>P</i> < 0.05 was considered significant at a 95% confidence level).</p><p><strong>Results: </strong>Patients in the VOT group showed significantly higher QoL scores (44.10 ± 4.60, 59.36 ± 5.56) compared to the DOTs group (34.39 ± 2.88, 48.80 ± 4.05) after completing intensive and continuous phases of treatment, respectively. These improvements were notable when compared to the initiation of treatment scores (17.23 ± 4.27 for VOT and 10.82 ± 4.07 for DOTs), indicating sustained positive outcomes.</p><p><strong>Conclusion: </strong>This study provides robust evidence that integrating VOT into standard TB treatment protocols significantly enhances patients' QoL and reduces the overall disease burden.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 1","pages":"17-22"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900403/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146202494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Renaissance of Phase I trials in India: Lessons from global trials and tribulations of TGN1412.","authors":"Arun Bhatt, Sanish Davis","doi":"10.4103/picr.picr_413_25","DOIUrl":"10.4103/picr.picr_413_25","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900410/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146202454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}