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Evaluation of factors that act as barriers in conducting academic trials – An investigator’s perception 评估阻碍学术试验开展的因素--研究人员的看法
Q2 Medicine Pub Date : 2023-12-19 DOI: 10.4103/picr.picr_76_23
S. Gajbhiye, G. Dakhale, C. Chindhalore, Ashish Vijay Gupta, E. T. Selvi
Academic trials are essential in investigating health research questions relevant to the society. Only a few leading research institutions in India have been engaged in academic trials. Thus, there is a need to understand what factors dampen the spirit of the academician in conducting academic clinical trials. The aim of the study is to evaluate the investigator’s perception of obstacles to carrying out academic trials and to identify factors that will motivate investigators in conducting academic trials We conducted a prospective observational study in a tertiary care hospital for 6 months. Faculty members working in academic institutes were selected. A structured questionnaire was designed for the study and administered using google forms. Responses were taken on a Likert scale. Validity and reliability assessments were carried out. Mann-Whitney test was applied to assess differences between demographic groups. P <0.05 was considered significant. Most of the participants rated applying for research grants (76%), obtaining funding for the study and making arrangements for compensation for trial-related events (75%) as extremely challenging. We found that the degree of challenge is significantly lower in the faculty members who conducted clinical trials in the past as against those who did not (P = 0.00069). We also found that the degree of challenge is significantly higher in the faculty members with <10 years of experience than those with >10 years of experience (P = 0.00001). Thus, to conclude the challenges faced by investigators were at multiple levels, most common being applying for research grants and making arrangements for the funds for payment towards participation or study-related injury. Faculty members with exposure to conducting clinical trials and with experience of more than 10 years had perceived a reduced degree of challenges.
学术试验对于调查与社会相关的健康研究问题至关重要。印度只有少数领先的研究机构从事学术试验。因此,有必要了解是哪些因素抑制了院士开展临床学术试验的精神。 本研究旨在评估研究者对开展学术试验的障碍的看法,并找出能激励研究者开展学术试验的因素。 我们在一家三级医院开展了一项为期 6 个月的前瞻性观察研究。研究选取了在学术机构工作的教职员工。研究设计了一份结构化问卷,并使用谷歌表格进行管理。采用李克特量表进行回答。对问卷的有效性和可靠性进行了评估。采用 Mann-Whitney 检验来评估人口统计组之间的差异。P 10 年工作经验(P = 0.00001)。 总之,研究人员面临的挑战是多方面的,最常见的是申请研究基金和安排资金用于支付参与研究或与研究相关的伤害。接触过临床试验并拥有 10 年以上经验的教员所面临的挑战程度较低。
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引用次数: 0
An observational study to evaluate the awareness of drug treatment, prescription pattern, adverse drug reactions, and adherence in patients of major depressive disorder 一项旨在评估重度抑郁症患者对药物治疗的认识、处方模式、药物不良反应和依从性的观察性研究
Q2 Medicine Pub Date : 2023-12-06 DOI: 10.4103/picr.picr_113_23
U. Parmar, Pranali Puradkar, Kranti Kadam, Firoz M. Tadavi, Snehalata Gajbhiye, Shirish Joshi, Amitoj Sohal
Due to the paucity of studies in and out of India that dealt with treatment awareness of major depressive disorder (MDD), we decided to assess the awareness of MDD patients, and since adherence and awareness are linked to each other, we assessed adherence too. Prescription pattern studies identify changes in prescriptions due to poor initial response or adverse drug reactions (ADRs), which may result in dose reduction or switching medications and delay remission. Therefore, the study assessed the ADR pattern. A cross-sectional questionnaire-based study was carried out on 200 MDD patients with treatment records for at least 3 months after getting approval from the Institutional Ethics Committee and consent from the patients. The data obtained were entered in Microsoft Excel and analyzed using descriptive statistics. The mean age was 44.65 ± 12.02 years, and females were 70%. Maximum patients (98%) were aware of the consequence of stopping the drugs suddenly, and only 12.5% were aware of the onset of response to treatment. Escitalopram was the most common antidepressant prescribed (43.77%), and 67 ADRs out of 136 were attributable to it. Weakness and fatigue were the most common ADRs. The majority (97) of the ADRs were possibly related to antidepressants, and 65% of patients showed optimal adherence to medications. This study sheds light on the treatment awareness and adherence of MDD patients in India and highlights the need for educating patients about treatment response. It also emphasizes the importance of monitoring ADRs and adjusting prescription patterns accordingly to improve treatment outcomes.
由于印度国内外关于重度抑郁症(MDD)治疗意识的研究很少,我们决定评估MDD患者的意识,并且由于依从性和意识是相互关联的,我们也评估了依从性。处方模式研究确定由于初始反应差或药物不良反应(adr)而改变处方,这可能导致剂量减少或转换药物和延迟缓解。因此,本研究评估了不良反应模式。经机构伦理委员会批准并征得患者同意后,对200例治疗记录至少3个月的MDD患者进行横断面问卷调查研究。得到的数据在Microsoft Excel中输入,并使用描述性统计进行分析。平均年龄44.65±12.02岁,女性占70%。大多数患者(98%)意识到突然停药的后果,只有12.5%的患者意识到治疗反应的开始。艾司西酞普兰是最常见的抗抑郁药(43.77%),136例不良反应中有67例可归因于艾司西酞普兰。虚弱和疲劳是最常见的不良反应。大多数不良反应(97例)可能与抗抑郁药有关,65%的患者表现出最佳的药物依从性。这项研究揭示了印度重度抑郁症患者的治疗意识和依从性,并强调了对患者进行治疗反应教育的必要性。它还强调了监测不良反应和相应调整处方模式以改善治疗结果的重要性。
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引用次数: 0
Home nursing in clinical trials: Result from semi-structured qualitative interviews 临床试验中的家庭护理:半结构化定性访谈的结果
Q2 Medicine Pub Date : 2023-12-06 DOI: 10.4103/picr.picr_218_22
Pooja Sharma, S. Bhowmick, Kedar Nayak, Soma Bhattacharjee, Sandeep Lahiry
There is a need to transition from conventional (on-site) clinical trials (CTs) to trials conducted within the comfort of a patient’s home or community (decentralized CT) through e-consent, remote data monitoring, and telemedicine consults. This shift in trial procedures will positively impact recruitment rates, compliance and participant retention, protocol deviations, and delays or missed visits. Home nursing in CTs (HNCTs) will be an important component of this decentralization effort. A few limitations may impact the implementation of HNCT in India. In this regard, the workstream conducted semi-structured qualitative interviews with experts from diverse domains of CT conduct (researchers from academia and industry, clinicians, investigators, nursing staff, patient research advocates, institutional ethics committee, or institutional review board members, legal experts, and trial participants) to collect their understanding, perspectives, and the ground realities about HNCTs in India. The current review puts forth the key areas that would facilitate the establishment of HNCTs in India and provides recommendations for the same.
有必要通过电子同意、远程数据监测和远程医疗咨询,从传统的(现场)临床试验(CT)过渡到在患者家中或社区舒适地进行的试验(分散式CT)。试验程序的这种转变将对招募率、依从性和参与者保留率、方案偏差、延迟或错过就诊产生积极影响。ct的家庭护理将是这种权力下放工作的重要组成部分。一些限制可能会影响在印度实施HNCT。在这方面,工作流程与来自CT行为不同领域的专家(来自学术界和产业界的研究人员、临床医生、调查人员、护理人员、患者研究倡导者、机构伦理委员会或机构审查委员会成员、法律专家和试验参与者)进行了半结构化的定性访谈,以收集他们对印度hnct的理解、观点和实际情况。目前的审查提出了有助于在印度建立高毒性国家工作队的关键领域,并为此提出了建议。
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引用次数: 0
Trends of different inflammatory markers and clinical outcomes in hospitalized COVID-19 patients COVID-19 住院患者不同炎症指标的变化趋势和临床结局
Q2 Medicine Pub Date : 2023-11-15 DOI: 10.4103/picr.picr_123_23
Srikanth Krishnamurthy, Nandagopal Velayuthaswamy, Jaymohan Unnithan, Nagarajan Srinivasan, Shobana Balasubramaniam, Ramesh Jagannathan
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引用次数: 0
ChatGPT in medical writing: A game-changer or a gimmick? 医学写作中的 ChatGPT:改变游戏规则还是噱头?
Q2 Medicine Pub Date : 2023-11-15 DOI: 10.4103/picr.picr_167_23
Shital Sarah Ahaley, Ankita Pandey, Simran Kaur Juneja, Tanvi Suhane Gupta, Sujatha Vijayakumar
OpenAI’s ChatGPT (Generative Pre-trained Transformer) is a chatbot that answers questions and performs writing tasks in a conversational tone. Within months of release, multiple sectors are contemplating the varied applications of this chatbot, including medicine, education, and research, all of which are involved in medical communication and scientific publishing. Medical writers and academics use several artificial intelligence (AI) tools and software for research, literature survey, data analyses, referencing, and writing. There are benefits of using different AI tools in medical writing. However, using chatbots for medical communications pose some major concerns such as potential inaccuracies, data bias, security, and ethical issues. Perceived incorrect notions also limit their use. Moreover, ChatGPT can also be challenging if used incorrectly and for irrelevant tasks. If used appropriately, ChatGPT will not only upgrade the knowledge of the medical writer but also save time and energy that could be directed toward more creative and analytical areas requiring expert skill sets. This review introduces chatbots, outlines the progress in ChatGPT research, elaborates the potential uses of ChatGPT in medical communications along with its challenges and limitations, and proposes future research perspectives. It aims to provide guidance for doctors, researchers, and medical writers on the uses of ChatGPT in medical communications.
OpenAI 的 ChatGPT(生成预训练转换器)是一个聊天机器人,它能以对话的口吻回答问题并执行写作任务。在发布后的几个月内,多个领域都在考虑这款聊天机器人的各种应用,包括医学、教育和研究等领域,这些领域都涉及医学交流和科学出版。医学作家和学者使用多种人工智能(AI)工具和软件进行研究、文献调查、数据分析、参考文献和写作。在医学写作中使用不同的人工智能工具有很多好处。但是,在医学交流中使用聊天机器人会带来一些重大问题,如潜在的不准确性、数据偏差、安全性和道德问题。不正确的观念也限制了聊天机器人的使用。此外,如果使用不当或用于不相关的任务,ChatGPT 也可能具有挑战性。如果使用得当,ChatGPT 不仅能提升医学撰稿人的知识水平,还能节省时间和精力,将其用于需要专家技能的更具创造性和分析性的领域。本综述介绍了聊天机器人,概述了 ChatGPT 的研究进展,阐述了 ChatGPT 在医学交流中的潜在用途及其挑战和局限性,并提出了未来的研究展望。它旨在为医生、研究人员和医学撰稿人在医学交流中使用 ChatGPT 提供指导。
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引用次数: 0
Pharmaceutical sponsors and contract research organization’s perception toward genetic data reuse for future research 医药赞助商和合同研究组织对未来研究中基因数据再利用的看法
Q2 Medicine Pub Date : 2023-11-15 DOI: 10.4103/picr.picr_220_22
R. Devarinti, M. S. Ganachari
Pharmaceutical sponsors and Contract research organization plays vital role in the preparation and implementation of clinical trials and give rise to ethical predicaments that pertain to various aspects such as general or genetic consent, optional research, storage and utilization of genetic data and specimens, as well as disclosure of research findings to study participants. The current investigation is to assess the knowledge, attitudes, and practices of Clinical Research Organizations and Pharmaceutical Sponsors in relation to re-use of genetic research data for future research. A cross-sectional study conducted on pharmaceutical sponsor and their representatives from the metro cities, India. The present research encompassed N=50 of pharmaceutical sponsors and contract research organizations. Among these, 84% evinced cognizance regarding the re-use of genetic data in clinical trials. Furthermore, 62% of pharmaceutical sponsors and contract research organizations articulated apprehensions with respect to ethical and legal quandaries might arise due to the re-use of genomic data. A considerable proportion of participants are a willingness to share and reuse genetic data for future studies. However, it is observed that the perception towards practice is low, particularly in relation to the return of genetic results and ethical concerns while storing genetic samples. There are presently no universally accepted international Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines in place for the management of genetic sampling and data at the global level. In India, however, ICMR regulations exist to provide direction for the use of biological materials and datasets in research.
医药赞助商和合同研究组织在临床试验的准备和实施过程中发挥着重要作用,并在各方面引发了伦理困境,如一般或遗传同意、选择性研究、遗传数据和标本的储存和利用,以及向研究参与者披露研究结果等。 目前的调查旨在评估临床研究机构和药品赞助商对在未来研究中重复使用基因研究数据的认识、态度和做法。 研究对象为印度大城市的医药赞助商及其代表。 本研究涉及 50 家医药赞助商和合同研究组织。其中,84% 的人对在临床试验中重复使用基因数据表示认可。此外,62% 的药品赞助商和合同研究组织对基因组数据再利用可能引发的伦理和法律问题表示担忧。 相当一部分参与者愿意在今后的研究中共享和再利用基因数据。然而,我们注意到,人们对实践的认识并不高,特别是在基因结果的返还和基因样本储存的伦理问题上。 目前,国际人用药品技术要求协调会议(ICH)还没有制定全球普遍接受的基因采 样和数据管理准则。不过,印度有 ICMR 法规,为在研究中使用生物材料和数据集提供指导。
{"title":"Pharmaceutical sponsors and contract research organization’s perception toward genetic data reuse for future research","authors":"R. Devarinti, M. S. Ganachari","doi":"10.4103/picr.picr_220_22","DOIUrl":"https://doi.org/10.4103/picr.picr_220_22","url":null,"abstract":"Pharmaceutical sponsors and Contract research organization plays vital role in the preparation and implementation of clinical trials and give rise to ethical predicaments that pertain to various aspects such as general or genetic consent, optional research, storage and utilization of genetic data and specimens, as well as disclosure of research findings to study participants. The current investigation is to assess the knowledge, attitudes, and practices of Clinical Research Organizations and Pharmaceutical Sponsors in relation to re-use of genetic research data for future research. A cross-sectional study conducted on pharmaceutical sponsor and their representatives from the metro cities, India. The present research encompassed N=50 of pharmaceutical sponsors and contract research organizations. Among these, 84% evinced cognizance regarding the re-use of genetic data in clinical trials. Furthermore, 62% of pharmaceutical sponsors and contract research organizations articulated apprehensions with respect to ethical and legal quandaries might arise due to the re-use of genomic data. A considerable proportion of participants are a willingness to share and reuse genetic data for future studies. However, it is observed that the perception towards practice is low, particularly in relation to the return of genetic results and ethical concerns while storing genetic samples. There are presently no universally accepted international Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines in place for the management of genetic sampling and data at the global level. In India, however, ICMR regulations exist to provide direction for the use of biological materials and datasets in research.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139272302","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}
引用次数: 0
GENESIS-Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students research in health care: A research modeling experience from a newly established medical college GENESIS--以指导、教育、联网和赋权为基础的学生医疗保健研究智能倡议:一所新成立医学院的研究模式经验
Q2 Medicine Pub Date : 2023-11-10 DOI: 10.4103/picr.picr_88_23
Priyansh Nathani, Shreya Goyal, Yash Junnarkar, Khushi Prajapati
The importance of undergraduate medical research has been undermined in Indian medical education. Various studies show there is a drastic difference between the research output of Indian medical graduates in comparison to Western counterparts. With all the challenges identified, a student-oriented research committee was formed –Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students (GENESIS) research in health care – A research modeling experience from a newly established medical college. The structure was established to serve the needs of students in the field of research. Problems were identified with the help of a survey, and steps were taken to address the issues through its 4-pronged strategy that includes conducting regular journal clubs. Journal clubs follow a peer-to-peer learning strategy and provide an open stage for discussion. Second, a research tracker which helps in increasing the sustainability of a research project. The third strategy includes a research live matchmaker which helps in bridging the gap between the students and the faculties. Lastly, involving alumni in the initiative will help students get guidance and acts as a gateway to opportunities at the national level. For maintaining the integrity and sustainability of the initiative, the involvement of students from all the batches is made sure. Inputs from faculties and administration are taken on a regular basis. Interinstitutional collaborations and regular assessment and evaluation are done to ensure positive outcomes. With its focus on peer-to-peer mentoring and attempt to eliminate the barriers for research enthusiasts, GENESIS has the potential to make a lasting impact in promoting research culture in colleges.
在印度的医学教育中,本科生医学研究的重要性被削弱了。多项研究表明,印度医学毕业生的研究成果与西方同行相比差距巨大。在确定了所有挑战之后,一个以学生为导向的研究委员会成立了--医疗保健领域的指导、教育、网络和赋权型学生智能倡议(GENESIS)研究--一所新成立医学院的研究示范经验。建立该结构的目的是满足学生在研究领域的需求。通过调查发现了问题,并通过四管齐下的战略(包括定期举办期刊俱乐部)采取措施解决这些问题。期刊俱乐部采用点对点学习策略,为讨论提供了一个开放的舞台。其次,研究跟踪器有助于提高研究项目的可持续性。第三个策略包括研究现场配对,这有助于缩小学生与教师之间的差距。最后,让校友参与这一举措将有助于学生获得指导,并成为获得国家级机会的门户。为了保持活动的完整性和可持续性,确保所有批次的学生都参与进来。定期听取学院和行政部门的意见。为确保取得积极成果,还开展了机构间合作,并定期进行评估和评价。GENESIS 注重同侪指导,努力消除研究爱好者的障碍,因此有可能在促进高校研究文化方面产生持久影响。
{"title":"GENESIS-Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students research in health care: A research modeling experience from a newly established medical college","authors":"Priyansh Nathani, Shreya Goyal, Yash Junnarkar, Khushi Prajapati","doi":"10.4103/picr.picr_88_23","DOIUrl":"https://doi.org/10.4103/picr.picr_88_23","url":null,"abstract":"The importance of undergraduate medical research has been undermined in Indian medical education. Various studies show there is a drastic difference between the research output of Indian medical graduates in comparison to Western counterparts. With all the challenges identified, a student-oriented research committee was formed –Guidance, Education, Networking, and Empowerment-based Smart Initiative for Students (GENESIS) research in health care – A research modeling experience from a newly established medical college. The structure was established to serve the needs of students in the field of research. Problems were identified with the help of a survey, and steps were taken to address the issues through its 4-pronged strategy that includes conducting regular journal clubs. Journal clubs follow a peer-to-peer learning strategy and provide an open stage for discussion. Second, a research tracker which helps in increasing the sustainability of a research project. The third strategy includes a research live matchmaker which helps in bridging the gap between the students and the faculties. Lastly, involving alumni in the initiative will help students get guidance and acts as a gateway to opportunities at the national level. For maintaining the integrity and sustainability of the initiative, the involvement of students from all the batches is made sure. Inputs from faculties and administration are taken on a regular basis. Interinstitutional collaborations and regular assessment and evaluation are done to ensure positive outcomes. With its focus on peer-to-peer mentoring and attempt to eliminate the barriers for research enthusiasts, GENESIS has the potential to make a lasting impact in promoting research culture in colleges.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139281492","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}
引用次数: 0
Impact of the COVID pandemic on functioning of the institutional ethics committee: A comparison study COVID大流行对机构伦理委员会运作的影响:一项比较研究
Q2 Medicine Pub Date : 2023-10-27 DOI: 10.4103/picr.picr_79_23
Yashashri Chandrakant Shetty, Urmila Mukund Thatte, Amitrajit Pal, Janhavi Katkar
Abstract Purpose and Aim: In COVID 19 pandemic, it was essential to document the functioning of the institutional ethics committee (IEC), how the organization adapted and faced challenges posed, thus forming the rationale behind this particular audit. The objectives were to assess the impact of the pandemic on the structure, review process, outcomes, and administration of IEC and to compare the same during its functioning in the prepandemic stage. Subject and Methods: The study was conducted as a retrospective audit. After exemption from ethics review, the data were collected from the IEC office situated in KEM Hospital and were segregated into four domains: structure, review process, outcomes, and administration. The data were analyzed using descriptive statistics. Mann–Whitney U -test was used to compare the turnover time for approval of projects between the two study periods at 5% level of significance. SPSS software version 22 was used to analyze the data. Results: Constitution changed, more protocols pertaining to COVID 19 studies were reviewed, meetings frequency doubled, and Standard Operating Procedures was amended to incorporate the changes faced during pandemic. Significant decrease in turnover time was noticed with respect to submission to query letter and study completion. There were more protocol deviations. Financial burden and expenditure decreased due to less paperwork and meetings being held online. Conclusion The ethics committee infrastructure and functioning had to undergo a paradigm shift to adapt to the various changes and overcome the various hurdles occurring during the COVID-19 pandemic.
目的和目的:在2019冠状病毒病大流行期间,有必要记录机构伦理委员会(IEC)的运作情况,组织如何适应和应对所带来的挑战,从而形成本次审计背后的基本原理。目的是评估大流行对独立教育教育机构的结构、审查过程、结果和管理的影响,并对其在大流行前阶段的运作进行比较。研究对象和方法:采用回顾性审核方法。在免除伦理审查后,从位于KEM医院的IEC办公室收集数据,并将其分为四个领域:结构、审查过程、结果和管理。数据采用描述性统计进行分析。在5%显著性水平下,采用Mann-Whitney U检验比较两个研究期的项目审批周转时间。采用SPSS软件22对数据进行分析。结果:章程发生了变化,审查了更多与COVID - 19研究有关的协议,会议频率增加了一倍,并修订了《标准操作程序》,以纳入大流行期间面临的变化。在提交查询信和完成研究方面,周转时间显著减少。有更多的协议偏差。由于文书工作和会议在网上举行,财务负担和支出减少。伦理委员会的基础设施和职能必须经历范式转变,以适应新冠肺炎大流行期间出现的各种变化,并克服各种障碍。
{"title":"Impact of the COVID pandemic on functioning of the institutional ethics committee: A comparison study","authors":"Yashashri Chandrakant Shetty, Urmila Mukund Thatte, Amitrajit Pal, Janhavi Katkar","doi":"10.4103/picr.picr_79_23","DOIUrl":"https://doi.org/10.4103/picr.picr_79_23","url":null,"abstract":"Abstract Purpose and Aim: In COVID 19 pandemic, it was essential to document the functioning of the institutional ethics committee (IEC), how the organization adapted and faced challenges posed, thus forming the rationale behind this particular audit. The objectives were to assess the impact of the pandemic on the structure, review process, outcomes, and administration of IEC and to compare the same during its functioning in the prepandemic stage. Subject and Methods: The study was conducted as a retrospective audit. After exemption from ethics review, the data were collected from the IEC office situated in KEM Hospital and were segregated into four domains: structure, review process, outcomes, and administration. The data were analyzed using descriptive statistics. Mann–Whitney U -test was used to compare the turnover time for approval of projects between the two study periods at 5% level of significance. SPSS software version 22 was used to analyze the data. Results: Constitution changed, more protocols pertaining to COVID 19 studies were reviewed, meetings frequency doubled, and Standard Operating Procedures was amended to incorporate the changes faced during pandemic. Significant decrease in turnover time was noticed with respect to submission to query letter and study completion. There were more protocol deviations. Financial burden and expenditure decreased due to less paperwork and meetings being held online. Conclusion The ethics committee infrastructure and functioning had to undergo a paradigm shift to adapt to the various changes and overcome the various hurdles occurring during the COVID-19 pandemic.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136312543","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}
引用次数: 0
Clinical trial trends over the last 5 years among the BRICS (Brazil, Russia, India, China, and South Africa) nations 金砖国家(巴西、俄罗斯、印度、中国和南非)过去5年的临床试验趋势
Q2 Medicine Pub Date : 2023-10-27 DOI: 10.4103/picr.picr_179_23
Kaviya Manoharan, Juanna Jinson, Kalaivani Ramesh, Melvin George
Abstract Purpose: Although the Americas and Europe have historically dominated the global research landscape, emerging economies – Brazil, Russia, India, China, and South Africa (BRICS) have significantly increased their contributions in recent years. This article studies clinical trial trends in the BRICS nations between 2018 and 2022 and compares it with trends in the G7 nations (comprising Canada, France, Germany, Italy, Japan, the UK, the USA, and the European Union). This will help stakeholders in planning drug development strategies. Materials and Methods: Data were collected from the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and the World Bank database. An electronic search was done for the total number of trials registered between January 1, 2018, and March 15, 2023. Information was analyzed based on the year of registration, therapeutic area, type of intervention, sponsorship, and type of special population. The trial density indices (TDIs) were calculated based on population (Xi) and gross domestic product (GDP) (Yi) using author-derived formulae. Results: Altogether 2, 77, 536 trials from the BRICS and G7 were registered. China and the US had the most trials among the BRICS and G7, respectively. Between 2018 and 2022, the gap between the BRICS and G7 steadily reduced. The most common indication for clinical trials among the BRICS was cancer. Based on population, the TDI was the highest in China and the lowest in Russia. In proportion to the GDP, the TDI was maximum in Russia and minimum in India. Conclusion: There is a remarkable reduction in the gap in clinical trial trends between the BRICS and G7 nations. Among the BRICS, India and China are at the forefront in drug development. There is scope for improvement in trial density based on India’s population and GDP. Stakeholders are likely to utilize the strengths of the BRICS as an attractive destination for investment in this area.
摘要目的:尽管美洲和欧洲在历史上一直主导着全球研究格局,但近年来,新兴经济体——巴西、俄罗斯、印度、中国和南非(金砖国家)的贡献显著增加。本文研究了2018年至2022年金砖国家的临床试验趋势,并将其与G7国家(包括加拿大、法国、德国、意大利、日本、英国、美国和欧盟)的趋势进行了比较。这将有助于利益攸关方规划药物开发战略。材料和方法:数据收集自世界卫生组织国际临床试验注册平台(WHO ICTRP)和世界银行数据库。对2018年1月1日至2023年3月15日期间注册的试验总数进行了电子检索。根据注册年份、治疗区域、干预类型、赞助和特殊人群类型对信息进行分析。结果:共有来自金砖国家和七国集团的277,536项试验注册。中国和美国分别是金砖国家和七国集团中审判次数最多的国家。2018年至2022年,金砖国家与七国集团的差距稳步缩小。在金砖国家中,临床试验最常见的适应症是癌症。按人口计算,中国的TDI最高,俄罗斯最低。TDI与GDP的比例,俄罗斯最大,印度最小。结论:金砖国家和G7国家在临床试验趋势上的差距显著缩小。在金砖国家中,印度和中国在药物研发方面走在前列。根据印度的人口和GDP,试验密度还有改进的余地。利益攸关方可能会利用金砖国家的优势,将其作为该领域有吸引力的投资目的地。
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引用次数: 0
Perception and practices on COVID-19 vaccination and booster dose acceptability among health-care workers – A questionnaire-based study 卫生保健工作者对COVID-19疫苗接种和加强剂可接受性的认识和做法——一项基于问卷的研究
Q2 Medicine Pub Date : 2023-10-27 DOI: 10.4103/picr.picr_64_23
Nivethia K. Rathinakumar, Anandabaskar Nishanthi, Shanthi Manickam
Abstract Aim: To assess the perception and practices on COVID-19 vaccination and to determine the predictors of booster dose acceptability among health-care workers (HCWs) in South India. Materials and Methods: We conducted an anonymous cross-sectional survey on the perception and practices on COVID-19 vaccination and booster dose acceptability among the HCWs in South India. We prepared an online self-administered validated questionnaire, and the Google form link to it was circulated from March 28, 2022 to April 27, 2022, in the social media groups of the HCWs. We used binary logistic regression to identify the predictors of booster dose acceptability among HCWs. Results: Overall, we obtained 572 valid responses, of which the majority were from paramedical workers compared to doctors. Most of the respondents were unmarried females aged <30 years. Around 31.6% had been previously diagnosed with COVID-19. About 97.9%, 88.8%, and 12.6% of the participants have taken the first, second, and booster doses of the COVID-19 vaccine, respectively. Among the respondents, 19.7% refused to take the booster dose. The main reason for booster dose refusal is the belief that two doses of the COVID-19 vaccine are sufficient to confer disease protection. Believing vaccination to be one of the most effective measures in COVID-19 prevention and being doctors by profession were the chief predictors of booster dose acceptance among HCWs. Conclusion: While the uptake of the primary COVID-19 vaccination series was commendable among Indian HCWs, booster dose was taken only by a minority of them.
目的:评估南印度卫生保健工作者(HCWs)对COVID-19疫苗接种的认知和实践,并确定加强剂量可接受性的预测因素。材料和方法:我们对印度南部卫生保健工作者对COVID-19疫苗接种和加强剂量可接受性的认知和实践进行了匿名横断面调查。我们准备了一份在线自我管理的有效问卷,并于2022年3月28日至2022年4月27日在卫生保健工作者的社交媒体群中分发了谷歌表格链接。我们使用二元逻辑回归来确定医护人员加强剂量可接受性的预测因素。结果:总体而言,我们获得了572份有效回复,其中大部分来自医务辅助人员,而不是医生。大多数受访者是30岁的未婚女性。约31.6%的人之前被诊断出患有COVID-19。约97.9%、88.8%和12.6%的参与者分别接种了第一剂、第二剂和加强剂COVID-19疫苗。在受访者中,有19.7%的人拒绝接种加强剂。拒绝加强剂量的主要原因是认为两剂COVID-19疫苗足以提供疾病保护。认为疫苗接种是预防COVID-19最有效的措施之一和职业医生是卫生保健工作者接受加强剂量的主要预测因素。结论:虽然印度卫生保健工作者对COVID-19初级疫苗系列的采用值得赞扬,但只有少数人接种了加强剂。
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引用次数: 0
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Perspectives in Clinical Research
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