Perspectives in Clinical Research最新文献

{"title":"Is drug development in India is responsive to disease burden: A descriptive study.","authors":"Divya Goel, Arnav Gupta","doi":"10.4103/picr.picr_111_25","DOIUrl":"10.4103/picr.picr_111_25","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to investigate the association between approved drugs and disease burden in India and to assess the need to address the unmet healthcare needs of the public.</p><p><strong>Materials and methods: </strong>This descriptive study was conducted using two sets of data. The data on new drug approvals from January 2020 to August 2024 were downloaded from the Central Drugs Standard Control Organization website in India, and data on disease burden (mortality and disability) from 2017 to 2021 were downloaded from the World Health Organization website. The relationship between drug approval and disease burden was assessed using descriptive analysis.</p><p><strong>Results: </strong>From 2020 to 2024, a total of 126 new drugs were approved; of these 29.36% were approved for the leading causes of mortality and morbidity. Ischemic heart disease, chronic obstructive pulmonary disease, diabetes, diarrheal diseases, lower respiratory tract infection, and tuberculosis were among the leading causes of mortality and morbidity. A total of 19 (15%) drugs were approved for infectious diseases, including 9 (7%) for COVID-19. Other drugs approved included only 9 (7%) for cardiovascular disease, 8 (6%) for diabetes, and 1 (0.7%) for anemia.</p><p><strong>Conclusion: </strong>Our study found that although new drug development in India is increasingly focused on addressing the country's evolving disease burden of noncommunicable diseases and infectious diseases, a lower proportion of new drugs is being approved for the leading cause of morbidity and mortality. There is a need to intensify research output, as significant potential exists for improvement in drug development in India to address this issue.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 3","pages":"141-145"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466685/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148723318","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":"Redefining polypharmacy: Shifting from drug counts to patient-centered clinical appropriateness.","authors":"Trupal Bharatsinh Rathod, Anita A Mehta, Tejal Gandhi, Akshay Harshadkumar Shah","doi":"10.4103/picr.picr_196_25","DOIUrl":"10.4103/picr.picr_196_25","url":null,"abstract":"<p><p>This narrative review examines the evolving perspectives on polypharmacy within geriatric pharmacotherapy, emphasizing transition from numerical definitions to clinical appropriateness. It addresses the complex relationship between polypharmacy and health outcomes in older adults. It integrates data from emerging technologies in medication management, prescribing criteria tools, and deprescribing interventions. Appropriate polypharmacy can be helpful for managing multimorbidity, whereas inappropriate polypharmacy raises the risk of adverse events and mortality. Deprescribing interventions effectively reduce polypharmacy and potentially inappropriate medications, particularly in long-term care settings. To address existing gaps, we have proposed a deprescribing scoring tool that allows healthcare professionals to evaluate each medication's evidence base, risk profile, and alignment with patient goals. Prioritizing clinical relevance over medication count, along with innovative strategies such as deprescribing and new technologies, can improve therapeutic outcomes and quality of life for aging populations.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 3","pages":"128-133"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466619/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148726106","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 in HIV clinical trials in India: An analysis of Clinical Trials Registry of India data (2008-2025).","authors":"Arunkumar Ramaraj, Natarajan Thangam Nivasini, M Vikram Balaji, Jerin James, Sathyanarayanan Varadarajan","doi":"10.4103/picr.picr_102_25","DOIUrl":"10.4103/picr.picr_102_25","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 3","pages":"176-177"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148725502","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":"Qualitative research - Part 2 - Choosing a research design.","authors":"Vinitha Ravindran, Julia Hanebrink, Dylan Elizabeth Graetz, Asha Mathew, C S Pramesh, Priya Ranganathan","doi":"10.4103/picr.picr_195_26","DOIUrl":"10.4103/picr.picr_195_26","url":null,"abstract":"<p><p>The previous article in this series provided an overview of qualitative research, how it compares and contrasts with quantitative research, and an introduction to qualitative research approaches and designs. In this article, we delve deeper into the process of choosing an appropriate qualitative research design.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 3","pages":"171-175"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466617/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148725468","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":"Beyond consent: Reframing ethical governance in genetic data reuse within clinical trials.","authors":"Mrunalini Vinay Kalikar, Ganesh Dakhale","doi":"10.4103/picr.picr_172_26","DOIUrl":"10.4103/picr.picr_172_26","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 3","pages":"125-127"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466608/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148726906","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":"Disproportionality analysis of atrial fibrillation associated with direct oral anticoagulants: A pharmacovigilance study using the Food and Drug Administration adverse event reporting system database.","authors":"K Shambhavi, D Chinmay, N Ananya, M S Darshan, K B Rohith, S Prajwal","doi":"10.4103/picr.picr_310_25","DOIUrl":"10.4103/picr.picr_310_25","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 3","pages":"178-179"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466609/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148722173","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":"Surveillance of antimicrobial utilization among outpatient settings of a tertiary care hospital.","authors":"Niyati Trivedi, Janki Chauhan, Dhara Naik, Prashant C Shah, Nilima Kshirsagar","doi":"10.4103/picr.picr_226_25","DOIUrl":"10.4103/picr.picr_226_25","url":null,"abstract":"<p><strong>Background: </strong>Antimicrobial stewardship programs typically focus on inhospital settings, with limited information available on the quality of antimicrobial use in hospital outpatient clinics. Given the significant volume of antibiotic consumption in outpatient settings, effective surveillance and identification of target areas should be prioritized as a strategic plan to optimize antimicrobial use.</p><p><strong>Methodology: </strong>Prescriptions of the patients attending outpatient clinics of a tertiary care hospital containing at least one systemic antimicrobial agent (AMA) were screened. Patients' clinical and demographic data were entered into the case record form. Appropriateness of antimicrobial prescribing was defined as being in accordance with the ICMR standard treatment guidelines. Logistic regression analysis was used to assess the association between various independent variables with the appropriateness of prescribing.</p><p><strong>Results: </strong>35.34% (422/1194) of the outpatient prescriptions contained at least one AMA. Moreover, 36.96% (156/422) of the prescriptions containing antimicrobials deviated from the standard treatment guideline. Prescriptions for upper respiratory tract infections (URTIs) (115/156) (<i>P</i> < 0.0001) and prescriptions written by intern doctors (<i>P</i> < 0.0001) were significantly associated with inappropriate prescribing. Overall amoxicillin-clavulinic acid was the most commonly prescribed AMA in the outpatient setting and azithromycin was the most inappropriately prescribed AMA.</p><p><strong>Conclusion: </strong>Outpatient settings are a crucial component for the implementation of antibiotic stewardship strategies. Prescriptions for URTIs and those prescribed by intern doctors could be identified as high-priority conditions for intervention.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 3","pages":"151-155"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466605/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148726141","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 Subject Expert Committee meeting of minutes as a strategic metric for evaluating India's clinical research trajectory.","authors":"Tahir Ishrak Khan, Ashutosh Jani, Pooja N Kotla","doi":"10.4103/picr.picr_133_25","DOIUrl":"10.4103/picr.picr_133_25","url":null,"abstract":"<p><strong>Background: </strong>In India, the Central Drugs Standard Control Organization (CDSCO) regulates drug, device, and cosmetics to support evidence-based decisions, and the Ministry of Health and Family Welfare established Subject Expert Committees (SECs) for drug approvals and clinical trials (CTs). Initially, established as New Drug Advisory Committees with 12 panels in 2011, they were restructured as Subject Expert Committees (SECs) in 2014 and expanded to 25 panels in 2015, a COVID-19-specific SEC were introduced in April 2020 to expedite vaccine and therapeutic assessments. This study analyses four years of SECs meeting minutes to assess decision-making trends and regulatory consistency.</p><p><strong>Methods: </strong>A systematic review of the SECs' meeting minutes was conducted from January 1, 2018, to December 31, 2021. Applications were grouped into two categories: CTs and marketing authorization (MA), with consideration of waiver status. Each submission was further classified based on its regulatory outcome as approved, requiring modifications, or rejected.</p><p><strong>Results: </strong>Over 48 months, 551 s meetings reviewed 4563 agenda items, of which 3557 (77.95%) were evaluable, including 2170 (61.01%) CT applications and 1383 (38.88%) for MA, irrespective of a waiver request. Applications seeking a CT waiver were significantly more likely to be rejected (cOR: 10.13 [6.90, 14.87], <i>P</i> < 0.001), while oncology-related waivers had a higher approval likelihood (cOR: 7.18 [4.14, 12.48], <i>P</i> < 0.001). Variability in meeting minutes highlighted inconsistencies in decision-making and documentation across SEC panels.</p><p><strong>Conclusion: </strong>Our analysis of 4563 s applications shows high approval rates, particularly in oncology, ophthalmology, and vaccines. However, inconsistencies in meeting documentation limit transparency and regulatory predictability. Standardized reporting guidelines could enhance consistency, transparency, and stakeholder confidence in regulatory decisions.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 3","pages":"146-150"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148726163","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":"Regulatory considerations for messenger RNA vaccines: A comprehensive review on World Health Organization guidelines on development, production, and clinical evaluation.","authors":"Trapti Saxena, Almula Sharvani, Aluvala Stavika, Mirdhodie Rohini","doi":"10.4103/picr.picr_199_25","DOIUrl":"10.4103/picr.picr_199_25","url":null,"abstract":"<p><p>The messenger RNA (mRNA) vaccines have revolutionized vaccine development by enabling faster production compared to traditional methods. Comprehensive regulatory requirements for mRNA vaccines are required to ensure uniform quality, safety, and efficacy in this rapidly growing technology. Globally accepted World Health Organization (WHO) guidelines provide broad, adaptable recommendations to all national regulatory authorities, whereas others, such as the European Medicines Agencies (EMA's) draft guideline, provide European Union specific legally binding, highly detailed technical requirements such as impurity thresholds, validated functional testing, and strict stability protocols. The distinctions reflect WHO's function as a worldwide standard-setter against EMA's regional enforcement responsibilities. For India, as one of the world's major vaccine producers and a significant supplier to numerous countries and UN agencies, relying exclusively on WHO's generalized framework may be insufficient. India presents unique issues such as varying population needs, disease burdens, and cold chain infrastructure limits. Developing India-specific mRNA vaccination rules that are aligned with WHO and incorporate analytical detail from EMA would boost domestic innovation, facilitate global export acceptance, and assure swift, safe responses to future public health catastrophes.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 3","pages":"134-140"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466607/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148726688","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":"A prospective, observational study of efficacy and safety of desloratadine and bilastine in patients of chronic spontaneous urticaria.","authors":"Suchi Bansod, Mrunalini Vinay Kalikar, Smita Sontakke, Jayesh Ishwardas Mukhi, Bhagyashree Babanrao Supekar, Sneha P Pawar, Divya Raj","doi":"10.4103/picr.picr_291_25","DOIUrl":"10.4103/picr.picr_291_25","url":null,"abstract":"<p><strong>Purpose: </strong>Urticaria is a disease where there is development of short-lived itchy wheals (hives), angioedema, or both.[1] With a lifetime prevalence of up to 22%, it is a widespread skin disorder that affects the general population. Urticarial episodes lasting longer than 6 weeks are considered chronic spontaneous urticaria (CSU).[23] Bilastine is a novel second-generation H1-antihistamine approved by the Drugs Controller General of India for the symptomatic treatment of CSU. Till date, there are very few studies in the Indian population comparing the efficacy and safety of bilastine with second-generation antihistaminic. Hence, the study was planned to assess and compare the efficacy and safety of desloratadine and bilastine in patients of CSU.</p><p><strong>Aim: </strong>The aim of the study was to evaluate and compare the efficacy of desloratadine and bilastine in patients of CSU.</p><p><strong>Materials and methods: </strong>It was a randomized, open-label, parallel group, comparative study conducted in 60 patients of CSU attending the dermatology outpatient department of a tertiary care teaching hospital. Patients were divided into 2 groups of 30 each. They received either desloratadine 5 mg or Bilastine 20 mg once daily for 6 weeks, and efficacy and safety were assessed at 2-, 4- and 6-week follow-up visit.</p><p><strong>Results: </strong>Difference in MTSS was significant in bilastine as well as desloratadine, which showed that bilastine was equally efficacious as desloratadine. Adverse events were reported more in the desloratadine group.</p><p><strong>Conclusion: </strong>Bilastine is equally efficacious as desloratadine, and a favourable safety profile may make it a more tolerable H1-antihistaminic than desloratadine.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"17 3","pages":"162-166"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13466606/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148727391","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}