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A review of clinical trials registered in India from 2008 to 2022 to describe the first-in-human trials 回顾2008年至2022年在印度注册的临床试验,描述首次人体试验
Q2 Medicine Pub Date : 2023-10-16 DOI: 10.4103/picr.picr_124_23
Sowparnika Treasa Sabu, Shravan Venkatraman, Jerin Jose Cherian, Saibal Das, Monika Pahuja, Tulsi Adhikari, Shoibal Mukherjee, Nabendu Sekhar Chatterjee, Nilima Arun Kshirsagar
Abstract Aim: This analysis was conducted to review the number, and describe the characteristics of first-in-human (FIH) Phase 1 clinical trials registered in India from 2008 to 2022. Materials and Methods: The data were extracted from the Clinical Trials Registry – India database for all FIH Phase 1 clinical trials registered between 2008 and 2022. Early-phase trials that were not FIH trials (e.g., pharmacokinetic studies and drug–drug interaction studies) were excluded from the study. Results: A total of 1891 trials were retrieved and 220 were included in the analysis. Most of the investigational products were drugs (55%) followed by vaccines (38.2%). The most common therapeutic class of drugs was cancer chemotherapy (19.8%), followed by antimicrobial chemotherapy and endocrinology (18.2% each). The most common vaccine was the influenza vaccine (21.4%), followed by the measles–mumps–rubella vaccine (15.5%). The pharmaceutical industry was the predominant sponsor for most (91%) of the Phase 1 trials. Of the top five sites where most of the Phase 1 trials were conducted, three were private nonacademic centers (cumulatively 31%) and two were tertiary care medical colleges (cumulatively 9%). Conclusion: Phase 1 clinical trials seem to be conducted in India predominantly with industry sponsorship. There is a need to have an alternate ecosystem to take forward molecules that do not receive adequate attention from the industry and molecules that are of national health priority other than areas such as chemotherapy, antimicrobials, and endocrinology. The Indian Council of Medical Research is setting up Phase 1 clinical trial capacity for molecules that predominantly may arise from nonindustry channels.
摘要目的:本研究回顾了2008年至2022年在印度注册的首次人体(FIH) 1期临床试验的数量和特征。材料和方法:数据从印度临床试验注册中心数据库中提取,涉及2008年至2022年期间注册的所有FIH一期临床试验。非FIH试验的早期试验(例如,药代动力学研究和药物-药物相互作用研究)被排除在研究之外。结果:共检索到1891项试验,其中220项纳入分析。大多数研究产品是药物(55%),其次是疫苗(38.2%)。最常见的治疗类别是肿瘤化疗(19.8%),其次是抗菌化疗和内分泌治疗(各占18.2%)。最常见的疫苗是流感疫苗(21.4%),其次是麻疹-腮腺炎-风疹疫苗(15.5%)。制药业是大多数(91%)一期临床试验的主要赞助方。在进行大部分1期临床试验的前5个地点中,3个是私立非学术中心(累计31%),2个是三级医疗院校(累计9%)。结论:i期临床试验似乎主要在印度由行业赞助进行。需要有一个替代的生态系统来推进那些没有得到业界足够重视的分子和除了化疗、抗菌剂和内分泌学等领域之外的国家卫生优先领域的分子。印度医学研究委员会正在为主要可能来自非工业渠道的分子建立第一阶段临床试验能力。
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引用次数: 0
The role of remote data capture, wearables, and digital biomarkers in decentralized clinical trials 远程数据采集、可穿戴设备和数字生物标志物在分散临床试验中的作用
Q2 Medicine Pub Date : 2023-10-13 DOI: 10.4103/picr.picr_219_22
Deepa Chodankar, Tapan K. Raval, Jeyaseelan Jeyaraj
Abstract Decentralized clinical trials (DCTs) are gaining momentum in clinical research as these studies can be executed remotely through telemedicine and mobile/local health-care providers. The COVID-19 pandemic has further accelerated advances and adoption in this area. In the past few years, there has been significant development and growth in the use of remote data that are electronically transmitted from a clinical trial (CT) participant, from outside the clinical setting, to a data repository. Such data may include laboratory data, safety data, or outcome measures reported by the participant, the clinician or the observer. Similarly, wearable health monitoring devices are being increasingly used in health-care and CT settings. Digital biomarkers, which can support continuous measurement of physiologic parameters outside the physical confines of the clinical environment, are also creating new and improved opportunities for patient care and biomedical research, enabling remote monitoring and DCTs. There are several benefits to using remote data capture, wearables, and digital biomarkers in clinical health-care research; however, several questions and challenges still need to be addressed. In an effort to understand the adoption of these technologies in DCTs, and the challenges therein, the authors of this workstream conducted an online survey of clinical research stakeholders across India and reviewed 80 responses. The review article summarizes the key findings from this online survey.
分散临床试验(dct)在临床研究中获得了越来越多的动力,因为这些研究可以通过远程医疗和移动/本地卫生保健提供者远程执行。2019冠状病毒病大流行进一步加速了这一领域的进展和采用。在过去几年中,远程数据的使用有了显著的发展和增长,这些数据通过电子方式从临床试验(CT)参与者从临床环境之外传输到数据存储库。这些数据可能包括实验室数据、安全数据或参与者、临床医生或观察者报告的结果测量。同样,可穿戴式健康监测设备也越来越多地用于医疗保健和CT环境。数字生物标志物可以支持临床环境物理限制之外的生理参数的连续测量,也为患者护理和生物医学研究创造了新的和改进的机会,使远程监测和dct成为可能。在临床医疗保健研究中使用远程数据捕获、可穿戴设备和数字生物标志物有几个好处;然而,仍有一些问题和挑战需要解决。为了了解这些技术在dct中的应用及其面临的挑战,本工作流程的作者对印度的临床研究利益相关者进行了在线调查,并审查了80份回复。这篇综述文章总结了这次在线调查的主要发现。
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引用次数: 0
Exploring the trend of use of qualitative methods in randomized controlled trials. 探讨在随机对照试验中使用定性方法的趋势。
Q2 Medicine Pub Date : 2023-10-01 Epub Date: 2022-11-14 DOI: 10.4103/picr.picr_131_22
S R Disha, K Merin Eldhose, Yashashri Shetty
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引用次数: 0
Adherence to Consolidated Health Economic Evaluation Reporting Standards guidelines for published pharmacoeconomic studies in PubMed-indexed medical journals over a year (2021-2022). 在一年内(2021-2022年)在pubmed索引的医学期刊上发表的药物经济学研究遵循综合卫生经济评估报告标准指南。
Q2 Medicine Pub Date : 2023-10-01 Epub Date: 2023-04-17 DOI: 10.4103/picr.picr_7_23
Miteshkumar Maurya, Renuka Munshi
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引用次数: 0
Virtual clinical trials. 虚拟临床试验。
Q2 Medicine Pub Date : 2023-10-01 Epub Date: 2023-03-08 DOI: 10.4103/picr.picr_184_22
Priya Ranganathan, Rakesh Aggarwal, C S Pramesh

Virtual clinical trials refer to clinical trials that take advantage of digital technologies, including computer and mobile device apps, web-based tools, and remote monitoring devices, for one or more of the trial processes, such as participant recruitment, counseling, informed consent, measurement of endpoints, and/or adverse event monitoring, to obviate or reduce the need for participant visits to the trial site. The advantages of such trials may include higher recruitment rates, better compliance, lower dropout rates, reduction in time for trial completion, and lower costs. The use of such trials increased manifold during the COVID-19 pandemic and is likely to continue in the future.

虚拟临床试验是指利用数字技术(包括计算机和移动设备应用程序、基于网络的工具和远程监测设备)进行一个或多个试验过程(如参与者招募、咨询、知情同意、终点测量和/或不良事件监测)的临床试验,以避免或减少参与者前往试验现场的需要。这类试验的优势可能包括更高的招募率、更好的依从性、更低的退出率、更短的试验完成时间和更低的成本。在COVID-19大流行期间,此类试验的使用增加了许多,并可能在未来继续使用。
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引用次数: 0
Prescribing patterns and pharmacoeconomic analysis of antihypertensive drugs in South Indian population: A cross-sectional study. 南印度人群抗高血压药物的处方模式和药物经济学分析:一项横断面研究。
Q2 Medicine Pub Date : 2023-07-01 Epub Date: 2022-11-14 DOI: 10.4103/picr.picr_122_22
S Shanmugapriya, Saravanan Thangavelu, Aashiq Ahamed Shukkoor, P Janani, R Monisha, Varsha Elsa Scaria

Background: Global evidence-based recommendations for hypertension management are periodically updated, and ensuring adherence to the guidelines is imperative. Furthermore, the current high prevalence of hypertension effectuates a high health-care cost.

Purpose: To evaluate the prescribing patterns of antihypertensive drugs and other factors affecting blood pressure (BP) with the objective of assessing the proportion of patients achieving the target BP and to perform a pharmacoeconomic analysis in a South Indian population.

Materials and methods: In a cross-sectional study, 650 patients previously diagnosed with hypertension and already on treatment with one or more drugs were included. A prospective interview of patients was done using a prevalidated questionnaire on various factors in BP control. Prescribing patterns and pharmacoeconomic analyses, namely, cost acquisition, cost of illness, and cost-effectiveness analyses were carried out.

Results: Of 650 subjects, 257 (39.54%) achieved the target BP, while 393 (60.46%) did not. A significant association of age, occupational status, monthly family income, and area of residence in addition to physical activity and diet scores, with achieving target BP was noted. A significantly higher cost of anti-hypertensive drug treatment in achieving target BP (P = 0.02) was observed. Among patients who achieved target BP, 37.35% were on monotherapy and 48.25% on multiple drug therapy compared to 46.31% and 35.62%, respectively, in patients who did not. Average cost-effectiveness ratio were found to be Rs. 20.45 and Rs. 57.27, respectively, for single and multiple drug therapies, with incremental cost-effectiveness of Rs. 194.14 per additional patient treated with multiple free drug combinations.

Conclusion: This study identified the anti-hypertensive prescribing pattern and provided insight into the various pharmacoeconomic factors that play a significant role in attaining target BP in the treated population.

背景:全球高血压管理循证建议定期更新,确保遵守指南至关重要。此外,目前高血压的高患病率带来了高昂的医疗费用。目的:评估降压药的处方模式和其他影响血压的因素,目的是评估达到目标血压的患者比例,并对南印度人群进行药物经济学分析。材料和方法:在一项横断面研究中,纳入了650名先前被诊断为高血压并已接受一种或多种药物治疗的患者。对患者进行了前瞻性访谈,使用了一份关于血压控制中各种因素的预验证问卷。进行了处方模式和药物经济学分析,即成本获取、疾病成本和成本效益分析。结果:650名受试者中,257人(39.54%)达到了目标血压,393人(60.46%)没有达到目标血压。除体育活动和饮食得分外,年龄、职业状况、每月家庭收入和居住面积与实现目标血压之间也存在显著关联。观察到在达到目标血压方面,抗高血压药物治疗的成本显著较高(P=0.02)。在达到目标血压的患者中,37.35%的患者接受单药治疗,48.25%的患者接受多种药物治疗,而未达到目标血压患者的这一比例分别为46.31%和35.62%。单药和多种药物治疗的平均成本效益比分别为20.45卢比和57.27卢比,每增加一名接受多种免费药物组合治疗的患者,成本效益增量为194.14卢比。结论:本研究确定了抗高血压的处方模式,并深入了解了在治疗人群中对达到目标血压起重要作用的各种药物经济因素。
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引用次数: 0
Clinical studies with Cannabis in India - A need for guidelines for the investigators and ethics committees. 印度大麻临床研究——研究人员和伦理委员会需要指南。
Q2 Medicine Pub Date : 2023-07-01 Epub Date: 2023-06-26 DOI: 10.4103/picr.picr_159_22
Prakash Nayak, Gouri Pantvaidya, Priya Ranganathan, Sabita Jiwnani, Shalaka Joshi, Nithya Jaideep Gogtay

Cannabis is one of the world's oldest cultivated plants and the most commonly used recreational drug worldwide. The plant relevant for medicinal use is Cannabis sativa that has two pharmacologically active ingredients - delta-9-tetrahydrocannabinol that is psychoactive and cannabidiol that does not have psychotropic activity. The policy tapestry of Cannabis has undergone a significant change in the past few decades worldwide. Different countries have diverse policies, ranging from classifying use of Cannabis as illicit, to legalization of its use, both for medicinal and recreational purposes. Cannabis products are approved for use, for instance, in multiple sclerosis and Dravet syndrome (US Food Drug and Administration). Against this backdrop, we find that the knowledge foundations for use of Cannabis in clinical trials in India are still evolving. Conducting ethical research within a clinical trials framework is essential to understand dosing, formulation, shelf life, drug-drug interaction, tolerability, and safety before establishing its utility for various indications. In the absence of guidelines or a regulatory framework for conduct of these studies, the various Institutional Ethics Committees (IECs), which are responsible for reviewing projects related to Cannabis, face unique challenges with respect to the basic requirements. The principal investigators (PIs) are equally strained to find local guidance, recommendations, and literature in support of their application to the respective IEC, thus leading to an impasse and delay in initiating the proposed clinical studies with Cannabis. The present article addresses considerations, questions, and issues that affect the conduct of these clinical studies and recommends mandatory documents and some suggested guidelines for use by both PIs and IECs to take studies with Cannabis forward until such time that an interdisciplinary regulatory framework is firmed up by regulatory authority.

大麻是世界上最古老的栽培植物之一,也是世界上最常用的娱乐药物。与药用相关的植物是大麻,它具有两种药理活性成分——具有精神活性的δ-9-四氢大麻酚和不具有精神活性。在过去的几十年里,全球范围内的大麻政策发生了重大变化。不同的国家有不同的政策,从将大麻的使用归类为非法,到将其用于医疗和娱乐目的的合法化。大麻产品被批准用于治疗多发性硬化症和Dravet综合征(美国食品药品监督管理局)。在这种背景下,我们发现印度在临床试验中使用大麻的知识基础仍在不断发展。在临床试验框架内进行伦理研究对于了解给药、配方、保质期、药物相互作用、耐受性和安全性至关重要,然后才能确定其对各种适应症的效用。在缺乏进行这些研究的指导方针或监管框架的情况下,负责审查大麻相关项目的各个机构伦理委员会在基本要求方面面临着独特的挑战。主要研究人员(PI)同样难以找到支持其应用于各自IEC的当地指南、建议和文献,从而导致拟议的大麻临床研究陷入僵局和延迟。本文阐述了影响这些临床研究进行的考虑因素、问题和问题,并推荐了强制性文件和一些建议指南,供PI和IEC使用,以推进大麻研究,直到监管机构确定跨学科监管框架。
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引用次数: 0
Immunomodulatory effect of a proprietary polyherbal formulation on healthy participants: A single- blind, randomized, placebo- controlled, exploratory clinical study. 专利多羟基制剂对健康参与者的免疫调节作用:一项单盲、随机、安慰剂对照、探索性临床研究。
Q2 Medicine Pub Date : 2023-07-01 Epub Date: 2023-05-22 DOI: 10.4103/picr.picr_100_22
Suresh Khadke, Poonam Gupte, Akanksha Mourya, Amit Yadav, Sarika Mane, Asavari Joshi, Madhavi Mahajan, Manisha Mishra, Supriya Bhalerao

Context: Clinical study for immunity.

Aims: 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.

Settings and design: Single-blind, randomized, placebo-controlled, exploratory study in institutional setting.

Materials and methods: 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.

Statistical analysis used: Mean ± standard deviation and paired/unpaired t-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 p < 0.05, as the level of statistical significance.

Results: 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.

Conclusions: PPHF is an efficacious and safe formulation with immunomodulatory potential.

背景:免疫的临床研究。目的:本研究旨在评估在新冠肺炎大流行的背景下,标记为Kofol免疫片(KIT)的专有多羟基制剂(PPHF)对健康个体先天和适应性免疫反应的影响。设置和设计:在机构环境中进行单盲、随机、安慰剂对照、探索性研究。材料和方法:经伦理委员会批准,筛选出的18-35岁的健康个体随机接受PPHF/安慰剂治疗2个月。主要评估变量包括呼气峰流速(PEFR)、基于问卷的免疫状态、感知压力和生活质量(QOL),包括免疫特异性细胞计数(CD4+、CD8+)、细胞因子(干扰素γ[INF-γ]、肿瘤坏死因子α[TNF-α]、白细胞介素10[IL-10])和红细胞氧化应激(RBCs)(丙二醛(MDA)、谷胱甘肽过氧化物酶[GPx]),在第60天进行。使用的统计分析:参数数据分析采用平均值±标准差和配对/非配对t检验,非参数数据分析则采用中位数(范围)和Wilcoxon秩和检验/Mann Whitney检验。分类数据采用卡方检验进行分析。使用GraphPad InStat软件,版本9,p<0.05,作为统计学显著性水平。结果:在52名被招募者中,28人完成了研究。与基线相比,PPHF显著增加了PEFR,改善了免疫状态和生活质量。它还将感知压力从中度和重度降低到轻度。PPHF治疗后,血清IFN-γ水平几乎保持不变。PPHF显著降低RBCs中MDA含量,增加GPx。PPHF组TNF-α和IL-10分别显著降低和升高。PPHF治疗后的安全性参数保持在正常参考范围内。结论:PPHF是一种具有免疫调节潜力的安全有效的制剂。
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引用次数: 0
Strengthening postapproval oversight in research ethics committees: Challenges and solutions. 加强研究伦理委员会的审批后监督:挑战和解决方案。
Q2 Medicine Pub Date : 2023-07-01 Epub Date: 2023-07-03 DOI: 10.4103/picr.picr_151_23
Yashashri Chandrakant Shetty, Rajmohan Seetharaman
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引用次数: 0
Generating fit-for-purpose real-world evidence in Asia: How far are we from closing the gaps? 在亚洲生成符合目的的真实世界证据:我们离缩小差距还有多远?
Q2 Medicine Pub Date : 2023-07-01 Epub Date: 2023-06-05 DOI: 10.4103/picr.picr_193_22
Wen-Yi Shau, Sajita Setia, Salil Shinde, Handoko Santoso, Daniel Furtner

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.

由于外部有效性或可推广性有限,随机对照试验(RCT)产生的证据通常不能代表真实世界中的患者旅程和临床结果。基于真实世界数据的研究旨在将结果推广到更广泛的人群;然而,如果没有有效地管理外部因素或混杂因素的影响,因果关系和内部有效性可能会受到挑战,从而导致有缺陷的结果。收集高质量的真实世界证据(RWE)在亚洲至关重要,因为亚洲人群在随机对照试验中的代表性往往不足。此外,亚洲很少有国家在发布实用的基本原则和指导意见,为监管和报销决策提供和采纳证据方面赶上西方世界。然而,隐私和数据保护法普遍落后于电子医疗记录的技术发展。虽然在临床和监管决策中利用RWE具有巨大的潜力,但需要行业、政府和研究机构的集体努力,以制定标准化的实践,并建立在亚洲开发适合用途的RWE的能力。
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引用次数: 0
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Perspectives in Clinical Research
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