Perspectives in Clinical Research最新文献

{"title":"Declaration of Helsinki: Can it still serve as a North star for ethics in regulatory trials?","authors":"Sanish Davis","doi":"10.4103/picr.picr_247_22","DOIUrl":"10.4103/picr.picr_247_22","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/eb/37/PCR-14-1.PMC10003581.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9101540","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":"Electronic health record interoperability using FHIR and blockchain: A bibliometric analysis and future perspective","authors":"Gaurav Anand, Divya Sadhna","doi":"10.4103/picr.picr_272_22","DOIUrl":"https://doi.org/10.4103/picr.picr_272_22","url":null,"abstract":"Electronic health records (EHRs) constitute vital statistics, current health condition, ongoing therapies, and patient data; hence, their interoperability could be useful for epidemiologic and clinical research. Fast Healthcare Interoperability Resources (FHIR) and blockchain are currently “in-use” and tested for exchange of such data. The annual scientific production of publications for both FHIR and blockchain shows steady growth. The data interoperability and electronic data interchange have been introduced in the field of EHR in 2020, hence inferring that data interoperability is relatively a new domain. The thematic mapping suggested “interoperability” of EHR is well-developed and important for the structure of the research field.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"63 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136008454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Experience of the selected Ethics Committee of Pune city regarding the review of COVID-19 protocols during the pandemic.","authors":"Sonopant G Joshi, Abhijeet Ashok Safai, Samir Sumant Barve","doi":"10.4103/picr.picr_2_22","DOIUrl":"10.4103/picr.picr_2_22","url":null,"abstract":"A sudden upsurge in COVID-19 research during the pandemic in 2020 brought a tremendous workload over Ethics Committees (ECs). Altered lifestyles and changes in research-related approaches due to the pandemic posed a completely different scenario to ECs,[1] and compelled them to adopt new administrative and functional modalities.[2] In addition, the Indian Council of Medical Research (ICMR) released special guidelines for ethical review of research studies during the pandemic.[3] This study aimed at exploring the functioning and experiences of a selected EC from India during the pandemic.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 1","pages":"43-44"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ab/35/PCR-14-43.PMC10003585.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9101535","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 medical adherence, adverse drug reactions, and quality of life in post tubercular obstructive airway disease.","authors":"Vinita Awasthi,&nbsp;Sarvesh Singh,&nbsp;Narendra Kumar,&nbsp;Manoj Kumar,&nbsp;Amod Kumar Sachan,&nbsp;Rajiv Garg,&nbsp;Rahul Kumar","doi":"10.4103/picr.PICR_55_21","DOIUrl":"10.4103/picr.PICR_55_21","url":null,"abstract":"<p><strong>Background: </strong>Increasing incidence of tuberculosis is intensifying the posttubercular obstructive airway disease (PTOAD) in developing countries. Currently, there are no standard treatment guidelines for the management of PTOAD patients. The present study aims to evaluate the prescribing pattern, adherence, adverse drug reactions (ADRs), and quality of life (QoL) in PTOAD patients.</p><p><strong>Materials and methods: </strong>A prospective observational study was conducted to evaluate the prescriptions of PTOAD patients, estimating the medical adherence using Morisky 8-Item Medication Adherence Questionnaire, assessing ADRs using Hartwig's Severity Assessment Scale and assessing QoL using St. George's respiratory Questionnaire. Chi-square test, analysis of variance, paired <i>t</i>-test were used to compare the data. The significance of change in adherence status was assessed by Wilcoxon signed-rank test.</p><p><strong>Results: </strong>A total of 94 prescriptions of PTOAD were analyzed. Inhaled long-acting muscarinic antagonist was prescribed to 31.9% of patients. The most common inhaled fixed dose combination was long-acting beta-2 agonist with corticosteroid, prescribed to 52.1% of patients. At final follow-up, maximum percentage of patients were found to be highly adherent, i.e. 56.4%. Overall, 34% of patients have complained about mild category of ADRs. A significant improvement in QoL was observed. At baseline, mean forced expiratory volume in 1 (FEV₁) was 64.66% ±23.61%, which increased significantly to 73.34% ±21.60% on final follow-up (<i>P</i> < 0.001).</p><p><strong>Conclusion: </strong>Bronchodilators are the mainstay of treatment of PTOAD patients, since both the QoL and FEV1 were improved with treatments. However, to have good treatment outcome, strict adherence along with safety of the medications must be assured.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 1","pages":"20-25"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e4/04/PCR-14-20.PMC10003586.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9101539","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":"Investigator initiatives for academic trials: Dilemmas and difficulties","authors":"Usharani Pingali","doi":"10.4103/picr.picr_247_23","DOIUrl":"https://doi.org/10.4103/picr.picr_247_23","url":null,"abstract":"The strength of a country’s medical research capability can be gauzed by the number and quality of academic studies initiated and conducted in that country. Academic studies help bridge the knowledge lacunae between clinical trials and real-world scenarios and are pivotal in repurposing of existing drugs. The population-specific data generated by academic studies can help solve population-specific clinical queries and help in formulating precise guidelines and policies tailored to the specific population. To bolster the academic clinical trials arena in India, the Central Drugs Standard Control Organization has laid down precise rules and regulations pertaining to definition and conduct of academic clinical trials in “New Drugs and Clinical Trials Rules (NDCT), 2019.” As per NDCT 2019, an Academic clinical trial “means a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration or new dose or new dosage form, where the results of such a trial are intended to be used only for academic or research purposes and not for seeking approval of the Central Licensing Authority or regulatory authority of any country for marketing or commercial purpose.”[1] Further, the rules state that, academic clinical trials should be conducted in accordance with the ethical principles specified in the National Ethical Guidelines for Biomedical and Health Research involving human participants provided by Indian Council of Medical Research.[2] However, unlike regulatory clinical trials, academic clinical trials require approval only from an ethics committee registered with Department of Health research. In addition, they have the overall responsibility of oversight, monitoring, audit, and compensation for adverse event related to the trial. The potential challenges of conducting Academic clinical trials as per NDCT 2019 and ICMR Ethical guidelines, 2017, have been expounded in excellent articles by Bhatt and Konwar et al.[3,4] Despite the release of NDCT 2019, the current academic clinical trial scenario is India is still in its infancy and lagging behind other developed countries. To understand the current landscape of academic clinical trials in India, a multicenter study published in this issue of the journal[5] was conducted among 100 academicians from 3 tertiary care centers, located at Mumbai, Maharashtra. The study was conducted in two phases: phase 1 focused on estimating the approximate number of academic clinical trials in India by analyzing academic interventional studies registered in Clinical Trials Registry of India between April 2019 and October 2022, while phase 2 of the study utilized a questionnaire consisting of four domains on knowledge, awareness, practical experience, and potential challenges faced in conduct of academic clinical trials. The present study was fairly designed with a validated questionnaire and conducted at instit","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136005812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characteristics, attitudes, and the odds for positive attitude toward clinical trial: A study on Indonesian COVID-19 vaccine trial participants","authors":"Nani Maharani, Nuvi Gustriawanto, YettyM Nency, Endang Mahati, GlennF Yeremia, DimasT Anantyo, Rebriarina Hapsari, Mulyono Mulyono, SetyoG Pramudo, Nur Farhanah","doi":"10.4103/picr.picr_71_23","DOIUrl":"https://doi.org/10.4103/picr.picr_71_23","url":null,"abstract":"Aims: This study was performed to understand the Indonesian population’s characteristics and the factors that contribute to a more positive attitude toward participation in a clinical trial. Methods: A cross-sectional survey was conducted involving 402 COVID-19 vaccine trial participants in Semarang, Indonesia, utilizing self-reporting questionnaires consisting of questions related to socio-demographic characteristics and statements in a 5-scaled Likert Scale to assess the attitude toward vaccine trial. The odds for positive attitude were analyzed using Ordinal Logistic Regression to obtain the odd-ratio and 95% confidence interval. The P < 0.05 was considered statistically significant. Results: Most of the respondents were adults aged 22–64-year-old (89.30%), males (63.68%), married (77.61%), worked as an employee (59.70%), obtained information about the clinical trial from the Public Health Service (41.29%), had a low education level (40.80%), a low monthly income level (68.41%), with no previous participation in a clinical trial (90.80%). All respondents showed a good attitude toward the trial, with low education level, nonemployment status, fewer or no previous participation in clinical trials, and getting the information from the public health centers were the main predictors for better attitude toward vaccine trials. Conclusion: There was a positive attitude toward vaccine trials in the Indonesian population. The positive attitude could be driven by having a low education level, nonemployment status, fewer or no previous participation in the clinical trial, and getting information from public health centers.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"69 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136008214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gene therapy in India: Developments, challenges, and future directions","authors":"Geeta Jotwani, V. Dalal, MunnaLal Yadav, Akanksha Bhawsar","doi":"10.4103/picr.picr_119_22","DOIUrl":"https://doi.org/10.4103/picr.picr_119_22","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70839428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative study of efficacy and safety of cetirizine and bilastine in patients of chronic spontaneous urticaria: Open-label, randomized, parallel-group study","authors":"MrunaliniVinay Kalikar, VishakhaV Sinha, JayeshIshwardas Mukhi, AkhilBhagwan Giradkar, Smita Sontakke","doi":"10.4103/picr.picr_28_23","DOIUrl":"https://doi.org/10.4103/picr.picr_28_23","url":null,"abstract":"Purpose: Bilastine is a novel second-generation antihistaminic. Very few studies in Indian population have compared the safety and efficacy of bilastine with other second-generation antihistaminic like cetirizine. Hence, the present study was planned. Materials and Methods: This was a randomized, open-label comparative parallel group study conducted on 70 patients of chronic spontaneous urticaria (CSU). Patients either received cetirizine 10 mg or bilastine 20 mg once daily for 6 weeks. The primary endpoint was to find out the difference in the mean total symptom score (MTSS) at baseline and 6 weeks. The secondary endpoint was to find out changes in the scale of the number of wheals, change in pruritus scale, scale for size of wheal, change for interference of wheals with sleep, change in visual analog scale (VAS) for sedation, change in scale for intensity of erythema, and change in Scale for Extent of Skin Area Involvement (SESI). Results: Bilastine and cetirizine offer a significant reduction in MTSS, mean number of wheals, and mean pruritus scale at baseline to 1, 3, and 6 weeks. The mean difference in MTSS was significantly more in bilastine. Cetirizine showed a significant increase in VAS score for sedation as compared to bilastine. Both the drugs were well tolerated and safe. Adverse events like headache, gastric irritation, dryness of mouth, and sedation were more reported in cetirizine group. Conclusion: Bilastine was more efficacious than cetirizine in patients of CSU and the efficacy was seen earlier at 1 week, which was not seen in the cetirizine group.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"2019 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136008462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital.","authors":"Ganesh Nathuji Dakhale,&nbsp;Mrunalini Vinay Kalikar,&nbsp;Akhil B Giradkar,&nbsp;Vishakha V Sinha","doi":"10.4103/picr.PICR_293_20","DOIUrl":"https://doi.org/10.4103/picr.PICR_293_20","url":null,"abstract":"<p><strong>Background: </strong>Managing of SAE by all stakeholders i.e. principal investigator (PI), sponsor, and Institutional Ethics Committee (IEC), in an ethical manner is the most important indicator of participant safety during clinical trial. The present study was conducted with the objectives to assess the extent of regulatory compliance in reporting SAEs, relatedness and financial compensation given/recommended by various stakeholders.</p><p><strong>Methods: </strong>This was a retrospective observational study which involved analysis of SAE's reviewed by IEC. Administrative approval for accessing the documents was obtained and complete confidentiality was maintained. A total of 66 SAE of 34 regulatory clinical trials reported from January 2014 to March 2020 were analyzed.</p><p><strong>Result: </strong>When analyzed for relatedness, 16 (24.24%) of the reported SAEs were found related to the clinical trial and out of these, 7 were SAE of death. Among the remaining 50 SAEs, 48 (72.7 %) were not related to clinical trial .65 (98.48%) SAEs, initial report and final report were submitted to EC within timelines. All the 66 SAE reports were sent by EC within stipulated time as required by regulation.</p><p><strong>Conclusion: </strong>The study concludes that 66 SAE reports were identified and there was no deviation in reporting timelines in initial reporting and due analysis report by PI and initial review by IEC in 65 SAE's. Similarly, analysis of SAE by IEC for relatedness, and provision of compensation to participant was achieved in majority of SAE. The study is unique in a way that qualitative and quantitative analysis of SAE reports was performed.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"13 4","pages":"189-193"},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/0a/2c/PCR-13-189.PMC9635352.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40468450","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 cross-sectional study of pre- and posttraining evaluation of inhaler use technique among outpatients with bronchial asthma or chronic obstructive pulmonary disease at a tertiary care hospital in India.","authors":"Selvaraj Nitya,&nbsp;Sivagourounadin Kiruthika,&nbsp;R Meenakshi,&nbsp;H Suriya,&nbsp;S Yuvarajan","doi":"10.4103/picr.picr_328_20","DOIUrl":"https://doi.org/10.4103/picr.picr_328_20","url":null,"abstract":"<p><strong>Context: </strong>Management of asthma and chronic obstructive pulmonary disease (COPD) includes use of inhalers as an integral component of drug delivery. Awareness about inhaler devices along with demonstration of the usage of inhaler technique aids in the optimization of therapeutic outcome.</p><p><strong>Aim: </strong>This study aimed to assess the correct use of inhaler technique following pre- and posttraining sessions for the management of COPD and asthma among pulmonary outpatients at a tertiary care hospital.</p><p><strong>Settings: </strong>This prospective cross-sectional study was carried out among patients diagnosed with asthma or COPD and prescribed with inhaler medication in the form of pressurized metered-dose inhaler (pMDI), MDI with spacer, or dry powder inhaler (DPI).</p><p><strong>Subjects and methods: </strong>The inhaler device use by the patients was assessed initially, followed by a demonstration on inhaler device technique, and reassessed post training using a checklist.</p><p><strong>Statistical analysis: </strong>Comparison of the median total score of pretraining and posttraining inhaler technique was analyzed by Wilcoxon signed rank test. <i>P</i> < 0.05 was considered statistically significant.</p><p><strong>Results: </strong>Out of 144 patients, 55.6%, 27.7%, and 16.7% of them were prescribed pMDI, MDI with spacer, and DPI, respectively. Post inhaler technique training, about 79.2% of the patients were able to demonstrate the inhaler technique correctly compared to 52.1% prior to training. A statistically significant difference in the median score of inhaler technique has been observed before and after training.</p><p><strong>Conclusions: </strong>This study reports a significant improvement in the correct use of inhaler technique post training. In addition, the most frequent error among inhaler users was revealed to be in the breath actuation.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"13 4","pages":"184-188"},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/48/8b/PCR-13-184.PMC9635346.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40682861","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}