Perspectives in Clinical Research最新文献

{"title":"Immunomodulatory effect of a proprietary polyherbal formulation on healthy participants: A single- blind, randomized, placebo- controlled, exploratory clinical study.","authors":"Suresh Khadke,&nbsp;Poonam Gupte,&nbsp;Akanksha Mourya,&nbsp;Amit Yadav,&nbsp;Sarika Mane,&nbsp;Asavari Joshi,&nbsp;Madhavi Mahajan,&nbsp;Manisha Mishra,&nbsp;Supriya Bhalerao","doi":"10.4103/picr.picr_100_22","DOIUrl":"10.4103/picr.picr_100_22","url":null,"abstract":"<p><strong>Context: </strong>Clinical study for immunity.</p><p><strong>Aims: </strong>The present study aimed to assess the effect of proprietary polyherbal formulation (PPHF), labelled as Kofol immunity tablets (KIT) on innate and adaptive immune responses in healthy individuals, on the backdrop of COVID-19 pandemic.</p><p><strong>Settings and design: </strong>Single-blind, randomized, placebo-controlled, exploratory study in institutional setting.</p><p><strong>Materials and methods: </strong>Post Ethics Committee permission, screened healthy individuals of either sex aged 18-35 years were randomized to PPHF/Placebo for 2 months. Major assessment variables included peak expiratory flow rate (PEFR), questionnaire-based immune status, perceived stress, and quality of life (QOL) with immune-specific cell counts (CD4+, CD8+), cytokines (interferon gamma [IFN-γ], tumor necrosis factor-alpha [TNF-α], interleukin 10 [IL-10]), and oxidative stress in red blood cells (RBCs) (malondialdehyde (MDA), glutathione peroxidase [GPx]), done at day 60.</p><p><strong>Statistical analysis used: </strong>Mean ± standard deviation and paired/unpaired <i>t-</i>test for parametric data analysis while median (range) and Wilcoxon Rank sum test/Mann-Whitney test for nonparametric data analysis, were done. Categorical data was analyzed using Chi-square test. GraphPad InStat software, version 9 was used with <i>p</i> < 0.05, as the level of statistical significance.</p><p><strong>Results: </strong>Of 52 recruited, 28 individuals completed the study. PPHF significantly increased PEFR, improved immune status along with QOL compared to baseline. It also decreased perceived stress from moderate and severe grade to mild. Serum IFN-γ levels remained almost constant post-PPHF treatment. PPHF significantly decreased MDA and increased GPx in RBCs. Significant decrease and increase in TNF-α and IL-10, respectively, were seen in PPHF group. The safety parameters post-PPHF treatment remained within normal reference ranges.</p><p><strong>Conclusions: </strong>PPHF is an efficacious and safe formulation with immunomodulatory potential.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 3","pages":"130-138"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9e/8d/PCR-14-130.PMC10405535.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9962583","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":"Strengthening postapproval oversight in research ethics committees: Challenges and solutions.","authors":"Yashashri Chandrakant Shetty, Rajmohan Seetharaman","doi":"10.4103/picr.picr_151_23","DOIUrl":"10.4103/picr.picr_151_23","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 3","pages":"105-107"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c7/6d/PCR-14-105.PMC10405534.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9956241","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":"Generating fit-for-purpose real-world evidence in Asia: How far are we from closing the gaps?","authors":"Wen-Yi Shau,&nbsp;Sajita Setia,&nbsp;Salil Shinde,&nbsp;Handoko Santoso,&nbsp;Daniel Furtner","doi":"10.4103/picr.picr_193_22","DOIUrl":"10.4103/picr.picr_193_22","url":null,"abstract":"<p><p>Evidence generated by randomized controlled trials (RCTs) does not often represent the patient journey and clinical outcomes in the real world due to limited external validity or generalizability. Studies based on real-world data are intended to generalize results to the broader population; however, if the influence of external factors or confounders is not effectively managed, the cause-and-effect relationship and internal validity may be challenged, resulting in flawed results. The collection of quality real-world evidence (RWE) is crucial in Asia as there is often an underrepresentation of Asian populations in RCTs. In addition, few countries in Asia are catching up with the Western world in issuing practical foundational principles and guidance for conducting and adopting evidence for regulatory and reimbursement decisions. However, privacy and data protection laws are generally lagging behind technological developments in electronic medical records. While leveraging RWE in clinical and regulatory decision-making holds excellent potential, collective efforts across industry, governments, and research institutions are required for generating standardized practices and building capabilities for developing fit-for-purpose RWE in Asia.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 3","pages":"108-113"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c9/3a/PCR-14-108.PMC10405531.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9962586","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 audit of informed consent of online survey: Characteristics and adherence to prevalent guidelines.","authors":"Himel Mondal,&nbsp;Shaikat Mondal,&nbsp;Sachin Soni","doi":"10.4103/picr.picr_175_22","DOIUrl":"10.4103/picr.picr_175_22","url":null,"abstract":"<p><strong>Background: </strong>Research on human participants requires formal approval from a competent ethics committee. During the recruitment of the research participants, obtaining informed consent is a prerequisite. The online survey method is used by many researchers as it can collect the data from a diverse population in a short time.</p><p><strong>Aim: </strong>This study aimed to observe the characteristics and adherence to prevalent guidelines (set by the <i>Indian Council of Medical Research</i> [ICMR]) of informed consent coupled with online surveys.</p><p><strong>Methods: </strong>We collected the informed consent text from online survey links obtained from a network of colleagues who got a request to participate in a survey. Data were collected from July 2020 to June 2022. The text was anonymized for further analysis. The word count, sentences, and Flesch reading ease score were calculated. The adherence to ICMR guidelines where checked by two authors individually and a consensus was reached to prepare the final result.</p><p><strong>Results: </strong>A total of 44 online surveys in English were audited and among them, 10 did not have informed consent. The informed consent in 34 surveys had a median of 6 sentences and 84 words. The median reading ease score was 45.7 (college level). The majority of the consent states the purpose of the research (91.18%), the voluntary nature of the participation (85.29%), and mentioned that it is research (64.71%). However, the rest of the components are ignored by the majority of the survey consent form.</p><p><strong>Conclusion: </strong>Informed consent form with online surveys lacks adherence to the components suggested by ICMR. Hence, the forms should be made carefully by the researchers so that the vigor of informed consent is maintained in the online surveys.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 3","pages":"123-129"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/29/c2/PCR-14-123.PMC10405532.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9966010","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":"Designing and validating a research questionnaire - Part 1.","authors":"Priya Ranganathan,&nbsp;Carlo Caduff","doi":"10.4103/picr.picr_140_23","DOIUrl":"10.4103/picr.picr_140_23","url":null,"abstract":"<p><p>Questionnaires are often used as part of research studies to collect data from participants. However, the information obtained through a questionnaire is dependent on how it has been designed, used, and validated. In this article, we look at the types of research questionnaires, their applications and limitations, and how a new questionnaire is developed.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 3","pages":"152-155"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/dd/61/PCR-14-152.PMC10405529.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9956236","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":"An audit of medical postgraduate theses registered in the Clinical Trials Registry of India in 2019.","authors":"Shruti V Tilak,&nbsp;Pranav G Gawande,&nbsp;Padmaja A Marathe,&nbsp;Kruttika R Chitnis,&nbsp;Dhananjay K Kokate","doi":"10.4103/picr.picr_222_22","DOIUrl":"10.4103/picr.picr_222_22","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 3","pages":"156-157"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/00/bf/PCR-14-156.PMC10405533.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9962580","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":"Post-approval process: A challenge for ethics committees.","authors":"Aarti Halwai,&nbsp;Vina Vaswani","doi":"10.4103/picr.picr_214_22","DOIUrl":"10.4103/picr.picr_214_22","url":null,"abstract":"<p><strong>Context: </strong>Ethics committees (ECs) work toward upholding rights, dignity, safety, and well-being of research participants. They are also tasked with conducting oversight pre- and post-approval. ECs face various challenges in their functioning. Post-approval oversight is one of the major challenges, and various studies have stressed the importance of post-approval oversight.</p><p><strong>Aims: </strong>The aim of this study was to explore the challenges in the post-approval processes that are faced by the ECs and to suggest solutions to the most common challenges.</p><p><strong>Methods: </strong>We conducted a quantitative study contacting member secretaries of different ECs using an online Google Forms questionnaire. The questionnaire consisted of three domains and included questions about the description of the EC, conduct of post-approval activities, and challenges encountered during the post-approval process.</p><p><strong>Results and conclusion: </strong>We received responses from 61 member secretaries. We were able to identify challenges faced by the EC members in the post-approval process in the areas of site monitoring visit, review of post-approval submission (nonsubmission/incomplete submission/late submission of documents by PI, long time taken by reviewers, nonavailability of reviewers, nonadherence to timeline and too much paperwork), review of serious adverse events, and review of protocol deviations. Our study also noted the difference between accredited/assessed (National Accreditation Board for Hospitals and Healthcare Providers/Forum for Ethical Review Committees in the Asian and Western Pacific Region) ECs versus registered (Central Drugs Standard Control Organisation/Department of Health Research only) ECs by comparing the challenges.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 3","pages":"139-145"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/78/6d/PCR-14-139.PMC10405536.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9962581","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":"Unreported protocol deviations - The tip of the research-berg.","authors":"Uma Kulkarni,&nbsp;Ravi Vaswani,&nbsp;Mohammed Guthigar,&nbsp;Nagapati Bhat,&nbsp;Laxminarayan Sonde","doi":"10.4103/picr.picr_235_21","DOIUrl":"10.4103/picr.picr_235_21","url":null,"abstract":"<p><strong>Introduction: </strong>Failure to stay within an ethics committee (EC)-approved protocol limits is termed protocol deviation or violation (PD/PV), depending on the seriousness of the transgression and its attendant risks and/or harms. PD/PVs arise in the post-approval phase of the research and are often missed. Current guidelines expect ECs to detect, report and recommend suitable actions such that research participants' risks and harms are mitigated, to the extent possible.</p><p><strong>Objective: </strong>Yenepoya Ethics Committee-1 conducted an internal audit of ongoing postgraduate dissertations involving human participants to assess the occurrence of PD/PVs.</p><p><strong>Materials and methods: </strong>54 out of 80 postgraduates responded to our request for filling out a self-reported checklist. These responses were followed up with physical verification of the protocol-related documents.</p><p><strong>Results: </strong>Protocol transgressions were classified as non-compliance (administrative issues), protocol deviations (minor transgressions with minimal or less than minimal increase in attendant risk to participants) and protocol violations (serious transgressions with more than minimal increase in attendant risk to participants). The non-compliances included non-reporting for audit and non-reporting of PDs. Protocol deviations included non-conformance to EC validity, sample size, approved methodology, informed consent process and documentation and suboptimal data storage. No protocol violations were observed.</p><p><strong>Conclusion: </strong>We report PD/PVs from these 54 protocols - with our assessment on the negative impact it may have on scientific validity, harm to participants, EC functioning and credibility of the institution - in the hope that our readers appreciate this important aspect of the post-approval process in the functioning of an EC.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 2","pages":"68-74"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/74/81/PCR-14-68.PMC10267994.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9654969","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":"Educational intervention to improve knowledge, attitude, and practice of pharmacovigilance among resident doctors at a tertiary care hospital.","authors":"Sadhana Keshav Hingorani,&nbsp;Awani Yogesh Shah,&nbsp;Chaitali Dharmendra Mehta","doi":"10.4103/picr.picr_37_22","DOIUrl":"10.4103/picr.picr_37_22","url":null,"abstract":"<p><strong>Background: </strong>Physicians, residents, interns, pharmacists, and nurses, as major health-care providers, bear a great deal of responsibility for reporting adverse drug reactions (ADRs). Resident doctors are the backbone of health-care system; hence they play a significant role in detecting and reporting ADR, particularly for hospitalized patients, as they are in contact with a patient and available round the clock.</p><p><strong>Aims and objective: </strong>Hence, the purpose of this study was to assess the knowledge, attitude, and practice (KAP) regarding Pharmacovigilance among resident doctors and to improve reporting of ADR by training resident doctors for filling the ADR reporting form. Material: This was a prospective, cross-sectional, questionnaire-based study.</p><p><strong>Materials and methods: </strong>A prevalidated, structured KAP-relatd questionnaire was given to resident doctors before and after the educational intervention at a tertiary care teaching hospital. Pre- and post test questionnaires were then compared and statistical analysis was applied using McNemar's test and paired t-test.</p><p><strong>Result: </strong>A total of 151 resident doctors submitted the pre- and post questionnaires. The study result depicted that resident doctors lacked the knowledge in reporting the ADRs. Post educational training, resident doctors inclined a positive attitude toward reporting ADRs. KAP among resident doctors has improved significantly as a result of the educational intervention.</p><p><strong>Conclusion: </strong>The present requirement in India is to motivate the residents through continuous medical educations and trainings in order to enhance the importance of Pharmacovigilance practice.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 2","pages":"75-80"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/8a/80/PCR-14-75.PMC10267989.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9648656","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":"Implementation of research ethics training for postgraduate medical students - A learner-centered approach.","authors":"Mourouguessine Vimal,&nbsp;Anandabaskar Nishanthi,&nbsp;Rajendrakumar Nivaratirao Kagne","doi":"10.4103/picr.picr_135_22","DOIUrl":"10.4103/picr.picr_135_22","url":null,"abstract":"According to the World Federation of Medical Education document, research competency is essential for medical postgraduates globally.[1] On similar grounds, postgraduate medical students in India are mandated to do research as a part of their curriculum to acquire first‐hand learning experience and develop them as competent researchers.[2] However, they face many ethical problems during their research, and no formal teaching of research ethics is incorporated into their curriculum.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 2","pages":"102-103"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/68/d2/PCR-14-102.PMC10267992.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9648649","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}