Perspectives in Clinical Research最新文献

{"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":"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}

{"title":"Evaluation of self medication practices and prescription patterns in patients of chronic kidney disease: A cross-sectional, questionnaire based study.","authors":"Raakhi K Tripathi, Chaitali Pilliwar, Snehalata V Gajbhiye, Sujeet K Bhilwade, Tukaram Jamale","doi":"10.4103/picr.picr_308_23","DOIUrl":"10.4103/picr.picr_308_23","url":null,"abstract":"<p><strong>Background: </strong>Pharmacotherapy of chronic kidney disease (CKD) consists of prescribing myriad of drugs such as antihypertensives, antidiabetics, and phosphate binders to delay disease progression and control the comorbidities, resulting in inherent variability in prescriptions. In addition, tendency to self-medicate may further aggravate the condition. Hence, the present study was planned to assess self-medication practices and variability in prescription patterns in CKD patients.</p><p><strong>Methodology: </strong>A cross-sectional, questionnaire-based study approved by the ethics committee was conducted in CKD patients attending the nephrology outpatient department. The prescription details which included drug name, dosage form, dose, frequency, duration, and dosage instructions were recorded and prescription completeness was checked. To assess the tendency of CKD patients to self-medicate, each patient was administered a prevalidated [Content Validity Ratio (CVR) = 0.76] 8-item questionnaire which had dichotomous responses \"Yes\" and \"No\" and was scored as 2 and 0, respectively (total score 16).</p><p><strong>Results: </strong>Three hundred CKD patients (150 on hemodialysis and 150 nondialysis) yielded 300 prescriptions with 1272 drugs. It was evident that 33% of patients did self-medicate themselves with analgesics, and the mean score (7.81 ± 3.01) of self-medication practices was perceived significantly higher in the nondialysis group (8.41 ± 3.46). The most common classes of drugs prescribed in CKD patients were calcium channel blockers (41%), antidiabetic drugs (39%), diuretics (35%), gastrointestinal drugs (35%), and multivitamins (27%), with the average number of drugs being 5.84 ± 0.51.</p><p><strong>Conclusion: </strong>Nearly one-third of CKD patients were self-medicating with paracetamol, nonsteroidal anti-inflammatory drugs; more in the nondialysis group emphasizing reinforcement of patient education programs. The most common drugs prescribed were amlodipine, followed by metformin, and the average number of drugs was less in our setting, indicating vigilant dose prescribing in CKD patients.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 1","pages":"23-30"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759236/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047671","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":"Incidence of adverse drug reactions among tuberculosis patients initiated on daily drug regimen in a southern district of Karnataka.","authors":"R N Hithaish Kumar, Chythra R Rao, Ravindra Maradi, Shashikiran Umakanth, S V Chidananda Sanju, P S Balu","doi":"10.4103/picr.picr_20_24","DOIUrl":"10.4103/picr.picr_20_24","url":null,"abstract":"<p><strong>Aim: </strong>The study aimed to determine the incidence of adverse drug reactions (ADRs) among newly diagnosed tuberculosis (TB) patients receiving daily drug regimen with fixed-dose combination treatment under the National Tuberculosis Elimination Program.</p><p><strong>Materials and methods: </strong>A community-based prospective cohort study was carried out in the Udupi district. Over 12 months, all newly diagnosed TB patients of either gender were included from 63 primary health centers and 6 community health centers, and ADRs were recorded by personal interviews.</p><p><strong>Results: </strong>A total of 710 patients were enrolled, among whom 453 (63.8%), were males, and 257 (36.2%) were females. Pulmonary TB was diagnosed among 510 (71.8%) and 200 (28.2%) were extrapulmonary cases. During the intensive phase (IP) of treatment, 480 (67.6%) patients reported at least one ADR and 79 (11.1%) experienced two ADRs during IP and 31 (6.5%) had ADRs during the continuation phase. Out of 480, 140 (29.2%) had gastritis, 132 (27.5%) had vomiting, 105 (21.9%) had nausea, 60 (12.5%) had skin rashes, 27 (5.6%) had drug-induced hepatitis, and 16 (3.3%) had vision problems. Among 480 patients with ADRs, 462 (96.3%) had successful treatment outcomes, the remaining 17 patients (3.5%) died, and one (0.2%) had treatment failure.</p><p><strong>Conclusions: </strong>Adverse events were more common in the 1^st few months of treatment than in subsequent months. All mild-to-moderate ADRs were effectively managed, and most had successful treatment outcomes.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 1","pages":"31-37"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759235/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143046339","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":"Novel trial designs: Master protocol trials.","authors":"Priya Ranganathan, Vishal Deo, C S Pramesh, Mahesh P Parmar","doi":"10.4103/picr.picr_214_24","DOIUrl":"10.4103/picr.picr_214_24","url":null,"abstract":"<p><p>Conventional trial designs are resource and time-intensive. To accelerate the process of testing new interventions, we now have several novel research trial designs. This article focuses on master protocol trials, which allow several therapies to be tested within a single larger trial.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 1","pages":"50-53"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759229/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143046525","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":"Declaration of Helsinki 2024: Too much too late?","authors":"Deepa Chodankar, Arun Bhatt, Sanish Davis","doi":"10.4103/picr.picr_218_24","DOIUrl":"10.4103/picr.picr_218_24","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759231/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047667","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":"Antibiotics-induced pulmonary embolism: A disproportionality analysis in Food and Drug Administration database of Adverse Event Reporting System using data mining algorithms.","authors":"Pramod Kumar Adusumilli, Foujia Begum, Ankita Ashok Sangnure, Jeesa George","doi":"10.4103/picr.picr_10_24","DOIUrl":"10.4103/picr.picr_10_24","url":null,"abstract":"<p><strong>Background: </strong>Antibiotics are among the most commonly prescribed drugs. Unnecessary use of antibiotics is particularly concerning because antibiotics may be associated with a number of adverse drug events.</p><p><strong>Aim: </strong>The study was designed to detect the association between pulmonary embolism and antibiotics by disproportionality analysis in the Food and Drug Administration database of Adverse Event Reporting System (FAERS) using data mining algorithms (DMAs).</p><p><strong>Materials and methods: </strong>A retrospective case/noncase disproportionality analysis was performed in the FAERS database. This study was based on adverse events (AEs) reported to FAERS from 2004 Q1 to 2022 Q3. Reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC) were applied to measure the disproportionality in reporting. A positive signal of increased AE risk was defined as ROR >1, Chi-square >4, PRR R2 with the number of cases >3, and IC >0.</p><p><strong>Results: </strong>Total AEs in the FAERS database from 2004 Q1 to 2022 Q3 were found to be 26,555,430. Among which 80,809 reports of pulmonary embolism were considered. The same were selected for further analysis which showed that 11 antibiotics were reported for pulmonary embolism. The number of reports for minocycline, chloramphenicol, and moxifloxacin was found to be 113, 14, and 179. A significant potential signal was noted for minocycline (ROR - 2.87, Chi-square - 135.95, IC - 1.22), chloramphenicol (ROR - 3.35, Chi-square - 22.80, IC - 0.77), and moxifloxacin (ROR - 2.08, Chi-square - 99.37, IC - 0.83).</p><p><strong>Conclusion: </strong>This study found a statistically significant increased risk of reporting pulmonary embolism with minocycline, chloramphenicol, and moxifloxacin, although a causal relation cannot be definitively established.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 1","pages":"44-49"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759233/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047654","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}