Perspectives in Clinical Research最新文献

{"title":"Drug repurposing: Clinical practices and regulatory pathways.","authors":"K Saranraj, P Usha Kiran","doi":"10.4103/picr.picr_70_24","DOIUrl":"https://doi.org/10.4103/picr.picr_70_24","url":null,"abstract":"<p><p>Drug repurposing, also known as drug repositioning or reprofiling, involves identifying new therapeutic uses for existing drugs beyond their original indications. Historical examples include sildenafil citrate transitioning to an erectile dysfunction treatment and thalidomide shifting from a sedative to an immunomodulatory agent. Advocates tout its potential to address unmet medical needs by expediting development, reducing costs, and using drugs with established safety profiles. However, concerns exist regarding specificity for new indications, safety, and regulatory exploitation. Ethical considerations include equitable access, informed consent when using drugs off-label, and transparency. Recent advancements include artificial intelligence (AI) applications, network pharmacology, and omics technologies. Clinical trials explore repurposed drugs' efficacy, with regulatory agencies facilitating approval. Challenges include intellectual property protection, drug target specificity, trial design complexities, and funding limitations. Ethical challenges encompass patient autonomy, potential conflicts of interest due to financial incentives for industries, and resource allocation. Future directions involve precision medicine, AI, and global collaboration. In conclusion, drug repurposing offers a promising pathway for therapeutic innovation but requires careful consideration of its complexities and ethical implications to maximize benefits and minimize risks.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 2","pages":"61-68"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048090/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144019188","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":"Vitamin D supplementation trials: Navigating the maze of unpredictable results.","authors":"Shruti Singh, Rajesh Kumar Meena, Vikas Maharshi, Nishi Sinha, Neha Agarwal, Shuvasree Payra, Divya Harsha","doi":"10.4103/picr.picr_325_23","DOIUrl":"https://doi.org/10.4103/picr.picr_325_23","url":null,"abstract":"<p><p>Vitamin D supplementation studies in various pleiotropic outcomes often yield conflicting results. This complexity arises from various factors, including individual differences (baseline Vitamin D levels, genetics, ethnicity, age, and gender). This review aims to clarify the complexities in Vitamin D supplementation research by examining various influencing factors, ultimately providing a comprehensive understanding to guide future studies and offer more accurate insights into the health impacts of Vitamin D supplementation. For this review, we searched PubMed, Google Scholar, and ScienceDirect, analyzing observational studies, meta-analyses, and randomized controlled trials to identify key factors influencing the efficacy of Vitamin D supplementation. By synthesizing findings from diverse research, we aimed to illuminate the nuances shaping the outcomes of these trials. In conclusion, the review suggests that several demographic and biological factors such as baseline 25(OH)D levels, age, ethnicity, genetics, body mass index, diet, sun exposure, medications, comorbid conditions, socioeconomic status, and self-supplementation all play significant roles in the outcomes of Vitamin D supplementation trials. In addition, the dose and duration of therapy, choice of daily versus bolus dosing, route of administration, and the role of free and bound forms of Vitamin D contribute to the complexity of trial results. Vitamin D's pleiotropic effects extend beyond calcium regulation, impacting various health aspects. Inadequate blood levels can confound trial outcomes, emphasizing the importance of reaching appropriate 25(OH)D thresholds. Study design, sample size, bias minimization, and methodology are critical in influencing trial outcomes and designing studies that account for baseline levels and compliance is crucial for meaningful and accurate results. Standardized assays and internationally agreed-upon cutoff levels are essential to mitigate variability in 25(OH)D measurements and improve result reliability.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 2","pages":"69-74"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144042478","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":"Disruption of healthcare delivery and clinical trial operations during COVID-19: Lessons learned, planning for solutions.","authors":"Veena Shridhar Jaguste","doi":"10.4103/picr.picr_44_25","DOIUrl":"https://doi.org/10.4103/picr.picr_44_25","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 2","pages":"59-60"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048094/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144023287","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":"Comparison of pre-COVID-19 pandemic, lockdown, and postlockdown participant adherence in a phase IV clinical trial for the treatment of postexposure rabies prophylaxis.","authors":"Vijaya Laxman Chaudhari, Akshay Sanjay Argade, Saee Sudesh Hinglaspurkar, Nithya Jaideep Gogtay","doi":"10.4103/picr.picr_111_24","DOIUrl":"https://doi.org/10.4103/picr.picr_111_24","url":null,"abstract":"<p><strong>Context: </strong>One of the most frequent difficulties encountered in clinical trials is the failure to retain participants and this is doubly important when the disease is 100% fatal. Studies conducted during the COVID-19 pandemic regarding adherence have been equivocal.</p><p><strong>Aims: </strong>The aim of this study is to compare participant adherence in a phase IV clinical trial for postexposure rabies prophylaxis before the pandemic, during lockdown, and after lockdown.</p><p><strong>Settings and design: </strong>An observational study (audit).</p><p><strong>Subjects and methods: </strong>The study in May 2023 covers the period from October 2019 to March 2022. Individual participant files of recruited participants were examined for adherence to treatment in the prepandemic period, during lockdown, and postlockdown eras.</p><p><strong>Statistical analysis used: </strong>The primary outcome measure-participant adherence anti-rabies vaccination (ARV completion) in the three timelines was compared using the Chi-squared test. The secondary outcome measures: reasons for nonadherence and potential factors associated with it done by univariate followed by multivariate logistic regression. All analyses conducted at a 5% significance level.</p><p><strong>Results: </strong>A total of 455 (2046 ARV visits) participants were recruited in the original Phase IV study, with a mean (±standard deviation) age of 31.9 ± 16.23 years. The COVID-19 lockdown reported the highest nonadherence to ARV (5/26, 19%) due to travel restriction and fear of contracting SARS-CoV2 infection compared to prepandemic (9/144, 6%) and postlockdown (6/285, 2%) periods.</p><p><strong>Conclusion: </strong>There was a significant reduction in participant adherence for ARV completion during the lockdown compared to the prepandemic and postlockdown timelines. Decentralized Clinical Trials may offer potential solutions to improve adherence in the context of epidemics and pandemics.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 2","pages":"92-98"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048096/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144012146","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":"Role of lay person in ethics committee: Bridging expertise and public trust.","authors":"Dakhale Ganesh, Mrunalini V Kalikar","doi":"10.4103/picr.picr_232_24","DOIUrl":"https://doi.org/10.4103/picr.picr_232_24","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 2","pages":"99-101"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048089/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144037876","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":"Time-to-event analysis.","authors":"Priya Ranganathan, Vishal Deo, C S Pramesh","doi":"10.4103/picr.picr_52_25","DOIUrl":"https://doi.org/10.4103/picr.picr_52_25","url":null,"abstract":"<p><p>Survival analysis (or time-to-event analysis) deals with data where the outcome of interest is the length of time until the occurrence of an event. This type of analysis is unique because the event may not occur in all participants (known as censoring). A previous article in this journal covered the basic aspects of conventional survival analysis. In this article, we discuss two unique features - nonproportional hazards (PH) and competing risks.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 2","pages":"102-105"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144009183","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":"Evaluation of the current status of ethics committees in India using the National Accreditation Board for Hospitals and Health-care Providers, Central Drugs Standard Control Organization (CDSCO), and Department of Health Research databases.","authors":"Trinath Panda, Prabodh Kumar Lala, Kaviya Manoharan, Juanna Jinson, Melvin George","doi":"10.4103/picr.picr_40_24","DOIUrl":"https://doi.org/10.4103/picr.picr_40_24","url":null,"abstract":"<p><strong>Purpose/aim: </strong>Ethics committees (ECs) have gained much importance since the introduction of the New Drugs and Clinical Trials Rules 2019. The committee report authored by Prof. Ranjit Roy Chaudhury suggested the need for accreditation of Institutional ECs. We aimed to enumerate the registered and accredited ECs across different geographical regions in India and to assess the adequacy of EC standard operating procedures (SOPs).</p><p><strong>Materials and methods: </strong>Our study was conducted between August and October 2022. The registration status of ECs was obtained from the Central Drugs Standard Control Organization (CDSCO) and Department of Health Research (DHR) websites. Information on accreditation status was obtained from the National Accreditation Board for Hospitals and Healthcare Providers (NABH) website. Registration data were categorized region-wise and available SOPs were collected from respective hospital websites and analyzed for adequacy.</p><p><strong>Results: </strong>We found that 1400 ECs in India were registered under CDSCO and 952 under DHR. Maharashtra had the largest number of registered ECs. Puducherry, Delhi, and Daman and Diu had the highest density of ECs. Bihar, Himachal Pradesh, and Jharkhand had the lowest. Only 299 ECs had their composition listed, and 111 had SOPs available on their websites. Most ECs lacked SOPs related to reviewing clinical trial agreements, compensation, and dealing with participant complaints.</p><p><strong>Conclusion: </strong>The advent of the New Drugs and Clinical Trials 2019 has created a definite impetus for increased responsibilities of ECs in India. Yet the registered ECs are not evenly distributed across the country. Moreover, it is disheartening to note that 90% of ECs in the country do not have NABH accreditation. Only a handful of ECs had SOPs posted on their websites.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 2","pages":"75-80"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048088/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993901","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":"Study on antifungal usage in patients with vaginal itching and discharge at a private hospital in Kolkata using the National Accreditation Board for Hospitals and Healthcare Providers and the World Health Organization prescribing criteria.","authors":"Ankita Roy, Arpan Ganguly, Soumyajit Pal, Subhrojyoti Bhowmick, Nina Das","doi":"10.4103/picr.picr_78_24","DOIUrl":"https://doi.org/10.4103/picr.picr_78_24","url":null,"abstract":"<p><strong>Introduction: </strong>One in every 10 women presents with abnormal vaginal discharge in Gynaecology and Obstetrics Department, with the most common cause being candidiasis. Irrational use of antifungal for treatment of this condition leads to antifungal resistance and increase morbidity.</p><p><strong>Materials and methods: </strong>This retrospective study was conducted at the Department of Pharmacology in collaboration of Department of Obstetrics and Gynaecology of the private medical college hospital in Kolkata. One hundred and forty outpatient department prescriptions were screened and included in this study from March 2024 to April 2024, and the prescriptions of the previous 6 months were collected.</p><p><strong>Results: </strong>The average number of drugs per prescription was 1.1. Antifungals were prescribed in 89.3%, out of which only 8.6% were in accordance with the standard treatment guidelines of management of vaginal candidiasis. The dose of the drug was written in 11.5% of the prescriptions while the duration of treatment was written in 84.9% of the prescriptions. The fungal culture and sensitivity testing was documented in only 10.7% of the prescriptions. 29.5% of the prescriptions had the generic name of the medicines whereas the complete diagnosis was written in only 13.7% of the prescriptions.</p><p><strong>Conclusion: </strong>This study highlights the commonly encountered errors in prescribing of antifungal drugs in a tertiary care teaching hospital. These errors may lead to irrational prescribing of antifungal and development of antifungal resistance in the long run. Active surveillance in the form of regular prescription audit and organizing regular training workshop for the prescribers will improve the prescribing practice.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 2","pages":"81-86"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048093/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144038033","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":"Medical writing bias in myeloma clinical research: A comprehensive analysis.","authors":"Adam ElSayed, Sarah Mettias, Ryan Danis, Susanna Kim, James R Berenson","doi":"10.4103/picr.picr_58_24","DOIUrl":"https://doi.org/10.4103/picr.picr_58_24","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 2","pages":"106-107"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048095/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144049938","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":"Adverse events associated with the use of radiopharmaceuticals: A prospective study from a tertiary care institute.","authors":"Kanhaiyalal Agrawal, Bikash Ranjan Meher, Abhinav Baranwal, Navneet Kumar","doi":"10.4103/picr.picr_89_24","DOIUrl":"https://doi.org/10.4103/picr.picr_89_24","url":null,"abstract":"<p><strong>Introduction: </strong>Radiopharmaceuticals (RPs) are used in the diagnosis and management of various cancer and noncancerous conditions. Like those of conventional drugs, the use of RPs may also be associated with the development of various adverse events (AEs). The information obtained from patients about these AEs may empower medical professionals to identify, evaluate, and manage them more efficiently to ensure the safe use of RPs.</p><p><strong>Objective: </strong>The objective of our study was to assess the type, timing, and frequency of the reported AEs associated with the use of RPs and to establish their causal association as well as to evaluate the outcome of these AEs from the perspective of patients.</p><p><strong>Methods: </strong>This study was a prospective cohort study conducted on 315 patients who underwent nuclear medicine examination in a tertiary care center for various indications. Relevant data were collected from the participants regarding suspected AEs associated with the use of various RPs. The collected data were objectively analyzed and assessed.</p><p><strong>Results: </strong>Of 315 patients, 39 (12.3%) developed 59 AEs. All the reported AEs were mild in nature and neither required hospitalization nor caused death of any participants. 37.2% of the reported AEs occurred within 1 h of administration of the RPs and spontaneously resolved within a few hours. Of these 59 AEs, 10 had causal associations (possible or probable) with RPs and were considered adverse drug reaction (ADR). The incidence of ADR in our study was 2.2%.</p><p><strong>Conclusion: </strong>RPs can cause ADRs though it is less in comparison to conventional drugs. We expect that our study will increase the awareness of AEs associated with the use of RPs among patients and health-care professionals and encourage its reporting.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 2","pages":"87-91"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048092/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144041042","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}