学术试验的研究者主动性:困境和困难

Q2 Medicine
Usharani Pingali
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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 institutions which are at the forefront of academic research in India. Although the results of the study are encouraging in terms of knowledge and awareness about academic clinical trials, there still exists some ambiguity regarding knowledge on approvals and compensation of academic clinical trials. An intriguing finding of the study is the paradoxical increase in the registration of academic clinical trials during the COVID year of 2020 with a progressive decline in the subsequent 2 years. Alarmingly, despite 89% of the academicians received training specifically on academic clinical trials, only 50% have actually conducted an academic clinical trial in the past 3 years. One of the major challenges which the investigators reported was related to obtaining approval from ethics committee and funding. Ethics committees have a challenging task of balancing science and ethics as they are the final authority for approval, monitoring, audit, and compensation of academic clinical trial. To add to this complexity, there is still a lot of ambiguity around rules for compensation of academic clinical trials as per ICMR. There is scope for standardization of standard operating procedures of ethics committees regarding oversight, audit, and compensation of academic clinical trials. This highlights the need for accreditation of ethics committees and robust training of ethics committee members to empower them to effectively assess, monitor, and audit the academic clinical trials. Yet, another challenge for the investigator and ethics committees is regarding industry sponsorship and use for commercial purpose. Despite signing a contract stating that the company will not use the results for commercial purposes, the ethics committees and investigators lack the time, financial, and legal resources necessary to ensure that the outcomes of academic clinical trials are not used for commercial purposes anywhere in the world. A few limitations, however, exist within this study. First a small and arbitrarily taken sample size from a single geographical center in a vast country like ours, limits the generalizability. Second, because the NDCT rules were released in March 2019 and CTRI registration typically occurs after ethics committee approval but before enrolling the first participant, the studies registered between April 2019 and August 2019 may not accurately reflect how the NDCT rules affected academic studies. Third, the number of academic clinical trials may be confounded, as the authors did not specifically study the funding of studies and CTRI does not yet have a clear demarcation between registration of academic clinical trials and investigator-initiated sponsored clinical trials. For both investigator-initiated studies (IIS) and academic clinical trials, the sponsor is the investigator, yet there is subtle difference in terms of funding and use of results for commercial purpose. Unlike an IIS, which can be used for commercial purpose, the rules are clear that the academic clinical trial results cannot be used for commercial purpose. Finally, the authors could also have studied the mechanism in place by the investigators and their institutes to ensure that academic clinical trials are not used for commercial purpose. It is a humongous task for the investigators and ethics committees to ensure that the results are not used for commercial purpose in any country despite having a legal agreement, especially so in this era of information and technology. To make scientific progress without commercial interests, it is essential to train academic investigators at an early stage to conceptualize, design, and conduct academic clinical trials. Further, there is imminent need to increase funding and formulate policies at an institute level to manage issues related to medical management and compensation for handling serious adverse event during an academic clinical trial. Perhaps, we as the clinical research community need to evolve our training methods to bridge the gap between training and actual implementation of academic clinical trial.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Investigator initiatives for academic trials: Dilemmas and difficulties\",\"authors\":\"Usharani Pingali\",\"doi\":\"10.4103/picr.picr_247_23\",\"DOIUrl\":null,\"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 institutions which are at the forefront of academic research in India. Although the results of the study are encouraging in terms of knowledge and awareness about academic clinical trials, there still exists some ambiguity regarding knowledge on approvals and compensation of academic clinical trials. An intriguing finding of the study is the paradoxical increase in the registration of academic clinical trials during the COVID year of 2020 with a progressive decline in the subsequent 2 years. Alarmingly, despite 89% of the academicians received training specifically on academic clinical trials, only 50% have actually conducted an academic clinical trial in the past 3 years. One of the major challenges which the investigators reported was related to obtaining approval from ethics committee and funding. Ethics committees have a challenging task of balancing science and ethics as they are the final authority for approval, monitoring, audit, and compensation of academic clinical trial. To add to this complexity, there is still a lot of ambiguity around rules for compensation of academic clinical trials as per ICMR. There is scope for standardization of standard operating procedures of ethics committees regarding oversight, audit, and compensation of academic clinical trials. This highlights the need for accreditation of ethics committees and robust training of ethics committee members to empower them to effectively assess, monitor, and audit the academic clinical trials. Yet, another challenge for the investigator and ethics committees is regarding industry sponsorship and use for commercial purpose. Despite signing a contract stating that the company will not use the results for commercial purposes, the ethics committees and investigators lack the time, financial, and legal resources necessary to ensure that the outcomes of academic clinical trials are not used for commercial purposes anywhere in the world. A few limitations, however, exist within this study. First a small and arbitrarily taken sample size from a single geographical center in a vast country like ours, limits the generalizability. 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引用次数: 0

摘要

一个国家医学研究能力的强弱可以通过该国发起和开展的学术研究的数量和质量来衡量。学术研究有助于弥合临床试验和现实世界情景之间的知识空白,对现有药物的再利用至关重要。学术研究产生的特定人群数据可以帮助解决特定人群的临床问题,并有助于制定针对特定人群的精确指导方针和政策。为了加强印度的学术临床试验领域,中央药物标准控制组织在“2019年新药和临床试验规则(NDCT)”中制定了与学术临床试验的定义和实施有关的精确规则和条例。根据NDCT 2019,学术临床试验“是指已经批准某种权利要求的药物的临床试验,并由任何研究者、学术或研究机构发起,用于新的适应症或新的给药途径或新剂量或新剂型,此种试验的结果仅用于学术或研究目的,而不用于向任何国家的中央发牌机关或监管机关申请批准用于营销或商业目的。“[1]此外,规则规定,学术临床试验应按照印度医学研究委员会提供的涉及人类的《国家生物医学和健康研究伦理准则》中规定的伦理原则进行。[2]然而,与监管性临床试验不同,学术性临床试验只需要获得在卫生研究部门注册的伦理委员会的批准。此外,他们还全面负责监督、监测、审计和赔偿与试验有关的不良事件。Bhatt和Konwar等人在优秀的文章中阐述了根据2019年NDCT和2017年ICMR伦理指南进行学术临床试验的潜在挑战。[3,4]尽管发布了2019年NDCT,但目前的学术临床试验情况是印度仍处于起步阶段,落后于其他发达国家。为了了解印度学术临床试验的现状,在本期杂志上发表的一项多中心研究[5]对来自位于马哈拉施特拉邦孟买的3个三级医疗中心的100名院士进行了研究。该研究分两个阶段进行:第一阶段侧重于通过分析2019年4月至2022年10月期间在印度临床试验登记处注册的学术介入研究来估计印度学术临床试验的大致数量,而第二阶段研究使用了由知识、意识、实践经验和进行学术临床试验面临的潜在挑战四个领域组成的问卷。本研究设计合理,采用了一份经过验证的问卷,并在印度学术研究前沿的机构进行。虽然本研究的结果在对学术性临床试验的认识和认知方面是令人鼓舞的,但在学术性临床试验的审批和补偿方面仍存在一些模糊的认识。该研究的一个有趣发现是,在2020年COVID年期间,学术临床试验的注册数量有所增加,但随后的两年却在逐步下降。令人担忧的是,尽管89%的院士接受过学术性临床试验的专门培训,但在过去3年中,只有50%的院士实际进行过学术性临床试验。研究人员报告的主要挑战之一与获得伦理委员会的批准和资金有关。伦理委员会是学术临床试验的批准、监督、审计和补偿的最终权力机构,因此,平衡科学与伦理的任务非常艰巨。更复杂的是,根据ICMR的规定,学术临床试验的补偿规则仍然存在很多含糊不清的地方。伦理委员会关于学术临床试验的监督、审计和补偿的标准操作程序有标准化的余地。这突出了对伦理委员会的认证和对伦理委员会成员的有力培训的必要性,以使他们能够有效地评估、监督和审计学术临床试验。然而,研究者和伦理委员会面临的另一个挑战是关于行业赞助和用于商业目的。尽管签署了一份合同,声明该公司不会将结果用于商业目的,但伦理委员会和调查人员缺乏必要的时间、财政和法律资源,以确保学术临床试验的结果不会在世界任何地方用于商业目的。然而,这项研究存在一些局限性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Investigator initiatives for academic trials: Dilemmas and difficulties
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 institutions which are at the forefront of academic research in India. Although the results of the study are encouraging in terms of knowledge and awareness about academic clinical trials, there still exists some ambiguity regarding knowledge on approvals and compensation of academic clinical trials. An intriguing finding of the study is the paradoxical increase in the registration of academic clinical trials during the COVID year of 2020 with a progressive decline in the subsequent 2 years. Alarmingly, despite 89% of the academicians received training specifically on academic clinical trials, only 50% have actually conducted an academic clinical trial in the past 3 years. One of the major challenges which the investigators reported was related to obtaining approval from ethics committee and funding. Ethics committees have a challenging task of balancing science and ethics as they are the final authority for approval, monitoring, audit, and compensation of academic clinical trial. To add to this complexity, there is still a lot of ambiguity around rules for compensation of academic clinical trials as per ICMR. There is scope for standardization of standard operating procedures of ethics committees regarding oversight, audit, and compensation of academic clinical trials. This highlights the need for accreditation of ethics committees and robust training of ethics committee members to empower them to effectively assess, monitor, and audit the academic clinical trials. Yet, another challenge for the investigator and ethics committees is regarding industry sponsorship and use for commercial purpose. Despite signing a contract stating that the company will not use the results for commercial purposes, the ethics committees and investigators lack the time, financial, and legal resources necessary to ensure that the outcomes of academic clinical trials are not used for commercial purposes anywhere in the world. A few limitations, however, exist within this study. First a small and arbitrarily taken sample size from a single geographical center in a vast country like ours, limits the generalizability. Second, because the NDCT rules were released in March 2019 and CTRI registration typically occurs after ethics committee approval but before enrolling the first participant, the studies registered between April 2019 and August 2019 may not accurately reflect how the NDCT rules affected academic studies. Third, the number of academic clinical trials may be confounded, as the authors did not specifically study the funding of studies and CTRI does not yet have a clear demarcation between registration of academic clinical trials and investigator-initiated sponsored clinical trials. For both investigator-initiated studies (IIS) and academic clinical trials, the sponsor is the investigator, yet there is subtle difference in terms of funding and use of results for commercial purpose. Unlike an IIS, which can be used for commercial purpose, the rules are clear that the academic clinical trial results cannot be used for commercial purpose. Finally, the authors could also have studied the mechanism in place by the investigators and their institutes to ensure that academic clinical trials are not used for commercial purpose. It is a humongous task for the investigators and ethics committees to ensure that the results are not used for commercial purpose in any country despite having a legal agreement, especially so in this era of information and technology. To make scientific progress without commercial interests, it is essential to train academic investigators at an early stage to conceptualize, design, and conduct academic clinical trials. Further, there is imminent need to increase funding and formulate policies at an institute level to manage issues related to medical management and compensation for handling serious adverse event during an academic clinical trial. Perhaps, we as the clinical research community need to evolve our training methods to bridge the gap between training and actual implementation of academic clinical trial.
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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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