Perspectives in Clinical Research最新文献

{"title":"Lessons from global materiovigilance systems: What India can learn?","authors":"Aditya Vikram Singh, Farida Ahmad, Syed Shariq Naeem, Mohammad Akram","doi":"10.4103/picr.picr_29_25","DOIUrl":"10.4103/picr.picr_29_25","url":null,"abstract":"<p><p>Medical devices are indispensable in modern healthcare, playing a crucial role in diagnosing, treating, and managing various medical conditions. While these devices offer significant benefits, they also pose potential risks due to defects, malfunctions, or adverse events, which can lead to serious patient harm. To mitigate these risks, materiovigilance - the systematic monitoring, detection, assessment, and prevention of adverse events related to medical devices - is essential for ensuring their safety, efficacy, and reliability. Many developed nations have established robust materiovigilance frameworks, incorporating stringent regulatory oversight, mandatory reporting mechanisms, and active stakeholder involvement. Countries such as the United States, the United Kingdom, and those within the European Union have implemented comprehensive postmarket surveillance programs that emphasize real-time adverse event reporting, manufacturer accountability, and transparent data sharing. Regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency enforce compliance through strict regulations, periodic safety evaluations, and corrective actions to address identified risks. These systems encourage proactive surveillance, industry responsibility, and public access to safety information, fostering trust in medical devices. In contrast, India's materiovigilance system is still evolving. The Materiovigilance Programme of India, launched in 2015, is a crucial initiative aimed at improving medical device safety. However, challenges remain, such as limited mandatory reporting, low awareness among healthcare professionals, underreporting of adverse events, and inconsistent regulatory enforcement. By analyzing global best practices, India can strengthen its materiovigilance framework through enhanced reporting infrastructure, greater stakeholder engagement, and stricter regulatory policies.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 1","pages":"4-8"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900398/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146202312","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":"Measuring quality of life in clinical research - Part 3.","authors":"Dagmara Kuliś, Priya Ranganathan, C S Pramesh, Jammbe Z Musoro","doi":"10.4103/picr.picr_410_25","DOIUrl":"10.4103/picr.picr_410_25","url":null,"abstract":"<p><p>Health-related quality of life (HRQoL) is an important outcome in cancer research, as it captures the impact of disease and treatment on patients' daily functioning and well-being. Building on earlier discussions of HRQOL concepts and measurement methods, this article focuses on HRQoL issues specific to patients with cancer and highlights key European Organisation for Research and Treatment of Cancer resources for HRQoL research in oncology.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 1","pages":"47-50"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900397/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146202399","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 the impact of a structured training program on knowledge of research methodology among anesthesiology trainees at a tertiary referral cancer center.","authors":"Maduri Sivateja, Priya Ranganathan","doi":"10.4103/picr.picr_115_25","DOIUrl":"10.4103/picr.picr_115_25","url":null,"abstract":"<p><strong>Purpose/aim: </strong>Knowledge of research methods is essential to appraise published literature and conduct good-quality research. Studies have shown that many postgraduate trainees lack adequate research knowledge. The aim of this study was to assess baseline knowledge of research methods and the impact of a structured training program on knowledge of research methodology among anesthesiology trainees at a tertiary referral cancer center.</p><p><strong>Methods: </strong>This prospective study included 60 1^st- and 2^nd-year anesthesiology residents. Participants completed a baseline questionnaire with 50 questions divided into 5 sections of 10 questions each: protocol writing/study conduct, study designs, research ethics, biostatistics, and research publication. This was followed by 12 webinars discussing these topics. At the end, the same questionnaire was administered as a posttest. Pre- and post-test scores were compared using the paired <i>t</i>-test for numerical data and Mcnemar's test for categorical data.</p><p><strong>Results: </strong>The mean test scores showed a significant improvement from 28.5/50 in the pretest to 35.5/50 in the posttest with a <i>P</i> < 0.0001 (95% confidence interval for difference: 4.2-9.6). Research ethics and study designs sections had the highest scores whereas statistics, and protocol writing/study conduct had the least scores. All 5 sections of the questionnaire showed improvements between 10% and 16%; however, these individual section differences were not statistically significant.</p><p><strong>Conclusion: </strong>Postgraduate trainees in anesthesiology have variable and inadequate knowledge of research methods. A structured training program helps to reduce these knowledge gaps.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 1","pages":"23-26"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900402/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146202364","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":"Efficacy and safety of topical phenytoin cream in diabetic foot ulcers: A randomized, open-label, parallel, and proof-of-concept study.","authors":"A Vinayak, Sujeet K Bhilwade, Aarsh P Gajjar, Anjali S Shah, Monty U Khajanchi, Mahesh N Belhekar, Ram P Prajapati, Bhaskar Krishnamurthy","doi":"10.4103/picr.picr_61_25","DOIUrl":"10.4103/picr.picr_61_25","url":null,"abstract":"<p><strong>Background: </strong>Diabetic foot ulcers (DFUs) are a severe diabetes complication, often leading to amputations. Despite medical advancements, no standard treatment exists. Conventional care is insufficient, prompting research into new therapies.</p><p><strong>Aims and objectives: </strong>Phenytoin, an antiepileptic drug, has shown potential in wound healing by stimulating fibroblast proliferation. This study evaluated the efficacy and safety of topical phenytoin cream versus standard care for DFUs.</p><p><strong>Materials and methods: </strong>This randomized, open-label trial was conducted at a tertiary hospital in India. Adults with diabetes and full-thickness lower extremity ulcers (Grade IA or II, University of Texas Classification) were randomized 1:1 to receive either topical phenytoin 1% cream or saline dressing daily for 8 weeks. The primary outcome was complete ulcer healing at 8 weeks. Secondary outcomes were healing time, ulcer size reduction, and adverse events. The primary outcome was analysed using the Chi-square test for independence, while secondary outcomes, namely time to wound closure, the percentage reduction in ulcer surface area and incidence of adverse events were analysed using the log-rank test, Mann-Whitney U test and Chi-square test respectively.</p><p><strong>Results: </strong>Among 28 participants, two were lost to follow-up. Healing rates were 23% (phenytoin) vs. 53% (saline) (p=0.102). Median healing time was 8 weeks in both groups (p=0.142). Ulcer size reduction was greater with saline (89.19% ± 17.33%) than phenytoin (56.51% ± 46.11%; p=0.037). Adverse events were fewer with phenytoin (p=0.431).</p><p><strong>Conclusion: </strong>Topical phenytoin was safe but not superior. Larger trials are needed to confirm its role in DFU treatment.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 1","pages":"33-38"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900407/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146202325","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":"Continuous review for ethical conduct of clinical trial-are the ethics committees complying?","authors":"Mrunalini Vinay Kalikar, Ganesh Dakhale","doi":"10.4103/picr.picr_184_25","DOIUrl":"10.4103/picr.picr_184_25","url":null,"abstract":"<p><p>Ethics committees (ECs) play a crucial role in safeguarding clinical trial participants through ongoing review beyond initial protocol approval. Although regulations require periodic monitoring of study progress, risk, protocol adherence, and informed consent processes, evidence from India indicates significant gaps in implementation.. Challenges such as limited resources, insufficient training, and lack of structured monitoring hinder effective continuous review. Strengthening EC capacity and accountability is essential to ensure ethical conduct and participant safety in ongoing clinical research.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 1","pages":"44-46"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900396/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146202332","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":"Trends and innovations in amphotericin clinical trials: Insights from the clinical trial registry of India.","authors":"Natarajan Thangam Nivasini, R Arunkumar, Vikram Balaji, P Kala, R Jamuna Rani","doi":"10.4103/picr.picr_55_25","DOIUrl":"10.4103/picr.picr_55_25","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 1","pages":"51-52"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900399/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146202475","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":"Statistical approaches in ambispective cohort studies: Challenges and methodological insights.","authors":"Pattabhi Ramayya Machiraju, Gomathi Priya Jeyapal","doi":"10.4103/picr.picr_190_25","DOIUrl":"10.4103/picr.picr_190_25","url":null,"abstract":"<p><p>Ambispective cohort studies combine retrospective and prospective data collection to provide a comprehensive understanding of treatment outcomes over time. This hybrid design offers several advantages, particularly in real-world settings where long-term patient follow-up is essential. However, integrating historical data with ongoing observations presents methodological challenges, including selection and temporal biases, missing data, confounding variables, and inconsistencies across data sources. This review outlines key statistical considerations for designing and analyzing ambispective studies. Challenges such as selection bias are addressed using methods such as propensity score matching and inverse probability weighting, while missing data are managed through multiple imputation. Time-dependent variables and confounders are tackled using Cox models, marginal structural models, and mixed-effects models. Techniques such as joint modeling, landmark analysis, and Bayesian frameworks help strengthen causal inference and account for temporal heterogeneity. A structured literature review was conducted across PubMed, Scopus, and Web of Science using predefined keywords related to ambispective design and statistical methods. Studies were selected based on relevance to real-world data/real-world evidence and the presence of statistical approaches to overcome design-related challenges. Data were extracted on study objectives and then thematically synthesized. This review highlights the importance of a robust statistical analysis plan, interdisciplinary collaboration, and methodological rigor. When appropriately designed and analyzed, ambispective studies offer a powerful framework for generating reliable, real-world insights to inform clinical and policy decisions.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 1","pages":"9-16"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146202472","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":"Impact of educational intervention on knowledge and awareness of good clinical practice among healthcare professionals at a tertiary care teaching hospital.","authors":"Mrunalini V Kalikar, Pradipta A Dutta, Shubham S Nimbhorkar","doi":"10.4103/picr.picr_62_25","DOIUrl":"10.4103/picr.picr_62_25","url":null,"abstract":"<p><strong>Background: </strong>Good clinical practice (GCP) ensures ethical, as well as scientific quality of clinical trials, thus safeguarding participant safety and data integrity. The drug controller general of India mandates GCP training for healthcare professionals who conduct clinical research. However, limited studies assess the effectiveness of such training programs in India.</p><p><strong>Aim: </strong>This study evaluates the impact of educational intervention on the knowledge and awareness of GCP among healthcare professionals.</p><p><strong>Settings and design: </strong>A prospective, interventional study was conducted at our tertiary care teaching hospital.</p><p><strong>Materials and methods: </strong>A total of 180 healthcare professionals participated in a GCP workshop, with 172 completing pre- and post-intervention questionnaires. The workshop covered essential GCP topics, including ethical guidelines, informed consent, regulatory requirements, and serious adverse event reporting.</p><p><strong>Statistical analysis used: </strong>Pre- and postintervention responses were analyzed using Fischer's exact test in GraphPad Prism 8.4.2. <i>P</i> < 0.05 was considered statistically significant.</p><p><strong>Results: </strong>The study revealed a significant improvement in participants' knowledge across multiple GCP domains. However, gaps remained in understanding specific regulatory timelines.</p><p><strong>Conclusion: </strong>Educational interventions, such as GCP workshops, significantly enhance healthcare professionals' knowledge and awareness, improving compliance with ethical and regulatory requirements in clinical research. Integrating GCP training into medical education may further strengthen research practices.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 1","pages":"39-43"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12900404/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146202305","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":"Artificial intelligence enabled audio-to-text transcription and translation for streamlined pharmacovigilance data collection and adverse drug reaction reporting.","authors":"Tasneem Hussain, Pooja Solanki Mishra, Ashutosh Tiwari, Manan Parmar, Shubham Gadaria, Pinkey Kannoj","doi":"10.4103/picr.picr_226_24","DOIUrl":"10.4103/picr.picr_226_24","url":null,"abstract":"<p><strong>Context: </strong>Adverse drug reaction (ADR) reporting in pharmacovigilance is critical for patient safety but often limited by resource constraints and manual inefficiencies. The integration of artificial intelligence (AI) has the potential to address these challenges by streamlining the reporting process.</p><p><strong>Aims: </strong>The aim of the study was to assess the performance of an AI-enabled system for audio-to-text transcription, translation, ADR form completion, and causality assessment based on the World Health Organization-Uppsala Monitoring Centre scale.</p><p><strong>Settings and design: </strong>A computational comparative, cross-sectional study involving healthcare professionals and patients to evaluate the AI system's functionality in a real-world pharmacovigilance setting.</p><p><strong>Methodology: </strong>A hundred participants (50 healthcare professionals and 50 patients) provided audio-recorded ADR reports. These recordings were processed through the AI system to generate transcriptions, translations, and ADR forms. The system's performance was assessed using transcription metrics (word error rate [WER], character error rate [CER], Sentence Error Rate [SER]), translation metrics (bilingual evaluation understudy [BLEU] score, Translation Edit Rate [TER]), and ADR form accuracy. Causality assessments by the AI were compared against expert evaluations.</p><p><strong>Statistical analysis used: </strong>Descriptive and analytical statistics (unpaired <i>t</i>-test) were applied to evaluate the performance metrics and compare results between the two participant groups.</p><p><strong>Results: </strong>The AI system demonstrated high accuracy in transcription (WER <0.05, CER <0.04, and SER <0.35) and translation (BLEU >0.85 and TER <0.05). ADR form completion achieved near-perfect accuracy with minor discrepancies. Causality assessments were consistent across healthcare professional and patient data (<i>P</i> = 1).</p><p><strong>Conclusions: </strong>The AI-enabled system effectively streamlined ADR reporting, ensuring accuracy in transcription, translation, and causality assessment while maintaining consistency across groups. Its integration into pharmacovigilance processes can reduce workloads, enhance reporting rates, and improve global health outcomes.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 4","pages":"211-217"},"PeriodicalIF":0.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12591525/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145482781","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":"Dual antihypertensive strategies: A real-world comparative study of efficacy and safety of fixed-dose combinations in a tertiary care setting.","authors":"Madhumita Dixit, Rakesh Chandra Chaurasia, Dwividendra Kumar Nim, Manoj Kumar Mathur","doi":"10.4103/picr.picr_165_24","DOIUrl":"10.4103/picr.picr_165_24","url":null,"abstract":"<p><strong>Aim: </strong>The aim of this study was to evaluate the comparative efficacy and safety of fixed-dose combinations of amlodipine 5 mg + hydrochlorothiazide 12.5 mg (A+H) (Group 1), telmisartan 40 mg + hydrochlorothiazide 12.5 mg (T+H) (Group 2), and ramipril 5 mg + hydrochlorothiazide 12.5 mg (R+H) (Group 3) in patients of essential hypertension.</p><p><strong>Materials and methods: </strong>A prospective, randomized, open-labeled study was conducted for a period of 12 months (April 2023-March 2024), at a single tertiary care center involving 327 patients that were newly diagnosed with essential hypertension without any comorbid conditions. Patients were assessed at baseline, 15 days, 1 month, and then followed up at monthly intervals up to 6 months.</p><p><strong>Results: </strong>In the study, significant reductions in systolic blood pressure (SBP) were noted for A+H with R+H at 3 and 4 months and for T+H with R+H from 3 to 6 months. Diastolic blood pressure (DBP) reductions were significant for A+H with R+H at 15 days and 1 month. T+H was significantly more effective than A+H and R+H in reducing SBP, while all groups showed comparable efficacy in reducing DBP over 6 months. Adverse drug reactions (ADRs) were highest in the A+H group at 29.4% and lowest in the T+H group at 19.8%.</p><p><strong>Conclusion: </strong>This real-world clinical study provided valuable insights into the comparative efficacy of different antihypertensive drug combinations, with T+H being most effective in reducing SBP; in terms of DBP, all the groups were equally efficacious.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 4","pages":"205-210"},"PeriodicalIF":0.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12591531/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145482729","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}