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Background: The number of new noncommercial clinical studies conducted in Japan declined within the first year of the implementation of the Clinical Trials Act (CTA) on April 1, 2018. This study aimed to examine the impact of the CTA’s enforcement on the number of new noncommercial clinical studies registered in the Japanese Clinical Trial Registry. Methods: An interrupted time-series design was used in the analysis, which was conducted from April 2015 to March 2019. We collected data for studies registered in the Clinical Trial Registry, managed by the University Hospital Medical Information Network. Results: In total, 35,811 studies were registered; of these, 16,455 fulfilled the eligibility criteria. The difference in the trend of monthly number of new studies after CTA enforcement decreased significantly by 15.0 (95% confidence interval [CI], −18.7 to −11.3), and the level decreased by 40.8 (95% CI, −68.2 to −13.3) studies from the pre-enforcement to the post-enforcement period. Multigroup analyses indicated that the act exerted a significant effect on the trend of new clinical studies, particularly those with smaller sample sizes, interventional study designs, and nonprofit funding sponsors. Conclusions: The number of Japanese noncommercial clinical studies declined significantly following implementation of the CTA. It is necessary to establish a system to promote clinical studies in Japan while ensuring transparency and safety.

Objective: large-scale multicentre clinical trials conducted by cooperative groups have generated a lot of evidence to establish better standard treatments. The Clinical Trials Act was enforced on 1 April 2018, in Japan, and it has remarkably increased the operational burden on investigators, but its long-term impact on cancer cooperative groups is unknown., Methods: a survey was conducted across the nine major cooperative groups that constitute the Japan Cancer Trials Network to assess the impact of Clinical Trials Act on the number of newly initiated trials from fiscal year (from 1 April to 31 March) 2017 to 2022 and that of ongoing trials on 1 April in each year from 2018 to 2023., Results: the number of newly initiated trials dropped from 38 trials in fiscal year 2017 to 26 trials in fiscal year 2018, surged to 50 trials in fiscal year 2019, but then gradually decreased to 25 trials by fiscal year 2022. Specified clinical trials decreased from 32 trials in fiscal year 2019 to 12 trials in fiscal year 2022. The number of ongoing trials was 220 trials in 2018, peaked at 245 trials in 2020, but then gradually decreased to 219 trials by 2023. The number of specified clinical trials has been in consistent decline. By April 2023, of the 20 ongoing non-specified clinical trials, nine adhered to Clinical Trials Act and 11 followed the Ethical Guidelines for Medical and Health Research Involving Human Subjects., Conclusion: the number of multicentre clinical trials in oncology gradually decreased after the Clinical Trials Act's enforcement, which underscores the need for comprehensive amendment of the Clinical Trials Act to streamline the operational process., (© The Author(s) 2024. Published by Oxford University Press.)

Background: Enforcement of the 2018 Clinical Trials Act (CTA) in Japan resulted in strict and complicated regulations surrounding intervention studies. Few Japan-specific measures have been developed to promote intervention studies in Japan despite concerns about CTA's negative influence on such studies. Therefore, this study examined the changes in academic investigators' interest in conducting clinical studies before and after enforcement of the CTA to determine measures to promote specified clinical trials. Methods: We conducted a questionnaire survey with investigators belonging to the Institute of Biomedical Sciences, Tokushima University Graduate School, before and after enforcement of the CTA. Results: Investigators had lesser interest in intervention studies in the post-questionnaire survey (post) group than in the pre-questionnaire survey (pre) group. Their desire for "project management" was significantly higher in the post-group than in the pre-group. Their desire for "support for preparing documents when conducting specified clinical trials" was significantly higher in the group interested in conducting specified clinical trials than that in the not-interested group. Conclusion: We revealed that investigators were highly interested in "project management" and "support for preparing documents when conducting specified clinical trials" after enforcement of the CTA. Measures for these desires may promote specified clinical trials. [ABSTRACT FROM AUTHOR]

This paper aims to publish an appended table for the Clinical Trials Act to decide the applicability of the law to studies on the development of nursing welfare and rehabilitation devices with mechanical loads in human subjects. Under the Clinical Trials Act, the specified clinical trials must have a medical or dental doctor as a representative. Ifthis limitation applies to challenging exploratory research involving human subjects, the majority of researchers other than medical or dental doctors will face difficulties of pursuing their studies under the law. Significantly, researchers should pay close attention to the delicate issue of whether their studies involve performing "medical practice." JSMBE announced a guideline for judgment of the applicability to clinical trials involving human subjects last year. The appended table in this paper supports researchers who are interested in nursing welfare and rehabilitation studies, especially those of gait, posture and balance, joint motion, and body pressure, to decide the applicability of the law. The authors, then, consider the appended table to show the standards or assessments for universities and research institutes processing large amounts of evidence and data for publication regarding what must be examined. [ABSTRACT FROM AUTHOR]

The Clinical Trials Act introduced in Japan in April 2018 requires measures to ensure the safety of subjects. As defined in the act, the term “clinical trials” refers to such research that is conducted to clarify an efficacy or safety of medicines, medical devices, and medical instrument by testing them in people, that is, by using them in a medical practice. If a research is recognized as a clinical trial, the act requests judicious procedure to conduct the research. However, the definition of medical practice has not been interpreted systematically. Therefore, medical-engineering researchers have difficulty in deciding whether their study involves a medical practice. As a result, the act may cause reduction of researches in biomedical engineering. Here, we try to clarify the principles used to decide whether a research is classified as a “clinical trial” and to provide a summary for medical-engineering researchers as a guideline of the Japanese Society for Medical and Biomedical Engineering. We apply the guideline to several examples to show its efficiency. [ABSTRACT FROM AUTHOR]

Background: The number of new noncommercial clinical studies conducted in Japan declined within the first year of the implementation of the Clinical Trials Act (CTA) on April 1, 2018. This study aimed to examine the impact of the CTA's enforcement on the number of new noncommercial clinical studies registered in the Japanese Clinical Trial Registry., Methods: An interrupted time-series design was used in the analysis, which was conducted from April 2015 to March 2019. We collected data for studies registered in the Clinical Trial Registry, managed by the University Hospital Medical Information Network., Results: In total, 35,811 studies were registered; of these, 16,455 fulfilled the eligibility criteria. The difference in the trend of monthly number of new studies after CTA enforcement decreased significantly by 15.0 (95% confidence interval [CI], -18.7 to -11.3), and the level decreased by 40.8 (95% CI, -68.2 to -13.3) studies from the pre-enforcement to the post-enforcement period. Multigroup analyses indicated that the act exerted a significant effect on the trend of new clinical studies, particularly those with smaller sample sizes, interventional study designs, and nonprofit funding sponsors., Conclusions: The number of Japanese noncommercial clinical studies declined significantly following implementation of the CTA. It is necessary to establish a system to promote clinical studies in Japan while ensuring transparency and safety.

In April 2018, the Clinical Trials Act pertaining to investigator-initiated clinical trials was passed in Japan. The purpose of this study was to investigate activity in investigator-initiated clinical studies before and after enforcement of the new Clinical Trials Act. This was done by analysing the records of the Ethics Committee of Tokushima University Hospital, which reviews studies based on the Japanese government's Ethical Guidelines for Medical and Health Research Involving Human Subjects prior to the Clinical Trials Act, and records of the Certified Review Board established at Tokushima University under the Clinical Trials Act in 2018. The number of new applications to these two review boards during fiscal years 2015-2017 (pre-Act) and fiscal years 2018 and 2019 (post-Act) were used as an indicator of activity in investigator-initiated clinical studies. The number of new applications to the Ethics Committee was 303, 261, 316, 303, and 249 in 2015, 2016, 2017, 2018, and 2019, respectively. The data show that the total number of new interventional studies decreased from 50.3 in average in 2015-2017 (pre-Act) to 42 in 2018 and 40 in 2019 (post-Act), respectively. These results suggest that fewer interventional studies were started following enforcement of the new Clinical Trials Act. To confirm this trend and identify contributing factors, further studies are required. In addition, possible way, such as broader contribution of clinical research coordinators, to promote clinical studies in the new Clinical Trials Act era should be examined.

Medical research is indispensable to develop new treatments or diagnostic methods. An ethics review board reviews the validity of such medical research. However, with the recent advances in medicine, a meaningful review of medical research often requires advanced knowledge. There is thus a growing necessity for a professional who can support ethical review. Therefore, a new system called the Certified Research Ethics Committee Professional (CReP), an Ethical Review Expert, has been established., Competing Interests: None, (Copyright © Japan Medical Association.)

The standard of care for lymphoid tumors has been established and is continually being updated, using the evidence generated through clinical research and development, including multicenter phase III trials. The Japan Clinical Oncology Group-Lymphoma Study Group is a multicenter research group that has been developing treatments for lymphoid malignancies for >40 years. This group is fully equipped with a system that guarantees a high level of scientific accuracy and quality and has produced considerable evidence based on the results of phase III trials. There are currently several issues in advancing clinical research. The strict legal regulation by the clinical trial act would be a burden for researchers in conducting clinical researches. From the perspective of developing a standard of care, researchers should always be aware of the difference in the significance between investigator-led and sponsor-led clinical trials that are intended to gain regulatory approval. Incorporating patient opinions from the early stages of treatment development and implementing genomic medicine are considered important issues for promoting clinical research.

Background : Enforcement of the 2018 Clinical Trials Act (CTA) in Japan resulted in strict and complicated regulations surrounding intervention studies. Few Japan-specific measures have been developed to promote intervention studies in Japan despite concerns about CTA's negative influence on such studies. Therefore, this study examined the changes in academic investigators' interest in conducting clinical studies before and after enforcement of the CTA to determine measures to promote specified clinical trials. Methods : We conducted a questionnaire survey with investigators belonging to the Institute of Biomedical Sciences, Tokushima University Graduate School, before and after enforcement of the CTA. Results : Investigators had lesser interest in intervention studies in the post-questionnaire survey (post) group than in the pre-questionnaire survey (pre) group. Their desire for "project management" was significantly higher in the post-group than in the pre-group. Their desire for "support for preparing documents when conducting specified clinical trials" was significantly higher in the group interested in conducting specified clinical trials than that in the not-interested group. Conclusion : We revealed that investigators were highly interested in "project management" and "support for preparing documents when conducting specified clinical trials" after enforcement of the CTA. Measures for these desires may promote specified clinical trials. J. Med. Invest. 68 : 71-75, February, 2021.

Objective: To describe changes in Japanese clinical trial regulations after the implementation of the Clinical Trials Act in April 2018., Methods: First, how to apply multiple regulations after the enforcement of Clinical Trials Act was described. Second, the changes in the number of clinical trials in the National Cancer Center Hospital under each regulation were compared before and after the implementation of Clinical Trials Act. Third, new requirements imposed by Clinical Trials Act and their influences were discussed., Results: In April 2018, Clinical Trials Act was enacted and academic clinical trials were classified into the following three categories: (i) investigator-initiated registration-directed trial under the Pharmaceuticals and Medical Devices Act; (ii) clinical trial under Clinical Trials Act; and (iii) clinical trial under the Ethical Guidelines. While 90% (205/227) of interventional studies were conducted under the Ethical Guidelines before the implementation of Clinical Trials Act in 2018, 46% (94/204) were subject to Clinical Trials Act in 2019 at the National Cancer Center Hospital. Under the Clinical Trials Act, investigators receive a scientific/ethical review by a certified review board (CRB). The identification of investigators in charge is mandated and they are required to submit the conflict of interest management plan to CRB. After the CRB review, the principal investigator must submit the trial plan to the government, and the content is uploaded to the newly established clinical trial registry site, the Japan Registry of Clinical Trials., Conclusions: The enforcement of the new Clinical Trials Act was supposed to improve the reliability of academic clinical trials in Japan; however, the financial and administrative burden may reduce clinical trial activity in the years to come., (© The Author(s) 2020. Published by Oxford University Press.)

Two years have passed since the Clinical Trials Act came into effect in April 2018. There were a series of research misconducts behind the legislation, and the Clinical Trials Act was enacted to ensure confidence in clinical trials conducted in Japan. The term "specified clinical trials" refers to clinical trials conducted using pharmaceuticals or medical devices, approval for which has not been obtained, or clinical trials conducted receiving research funds or other benefits provided by a manufacturer with marketing approval for pharmaceuticals or medical devices. The key elements in conducting specified clinical trials are as follows: (1) compliance with clinical trial standards, (2) approval by the certified review board, (3) submission of the trial plan to the Minister of Health, Labour, and Welfare, and (4) entering into an agreement with a manufacturer providing research funds. This manuscript overviews the Clinical Trials Act and the conduct of specified clinical trials by reviewing the key issues behind the legislation.

In the pharmaceutical industry, a Medical Affairs ("MA") professional collects, organizes and transmits information about a health care product based on the judgment of science, medicine and ethical values, thereby optimizing the product's value, improving corporate value, and assuring quality medical care. The role of the MA is to construct a "medical strategy" through the process of collecting, analyzing and evaluating information. On the other hand, Academic Detailing is "a new approach to drug information that actively disseminates drug comparison information from a pharmacological viewpoint, linking the drug's foundation to clinical practice." Cooperation between Academic Detailing and a pharmaceutical company's MA will be an essential relationship in realizing advanced prescribing proposals in the future, with the ultimate goal of optimal medication regimes for patients.

Currently, the role of medical representative (MR) is responsible for providing information to medical doctors from pharmaceutical/medical equipment companies. In recent years, however, the newer role of medical science liaison (MSL) has been established to construct evidence and provide advanced medical and scientific information to health care professionals. This position, independent from the sales division of a pharmaceutical or medical equipment company, has already been established in Europe and the U.S. The MSL helps to combat concerns of conflicts of interest (COI) concerning the sophistication of expert information, and in support of clinical research. I will introduce the role of the MSL in Japan.

Background: The new Clinical Trials Act that recently came into effect in Japan emphasizes the reliability of investigator-initiated clinical trials. Although Japanese clinical research coordinators have been mainly engaged in operational roles in industry-initiated clinical trials for drug approval (registration trials), broadening their contribution to cover more types of clinical research may lead to quality improvement of clinical research. To ultimately establish a clinical research infrastructure that meets the needs of the new era of Clinical Trials Act, here we gathered basic information on how clinical research coordinators might make such contributions., Methods: We conducted a survey using self-reporting questionnaires in clinical research-related personnel to examine present status and the perspectives toward broader contribution of clinical research coordinators. The study participants were attendee of group discussion of a clinical research-related meeting in Shikoku area of Japan held in August 2017., Results: Among 88 participants, 69 responded (response rate: 78.4%) and 68 respondents (98.6%) were engaged in support and management of clinical research. The main area of involvement was industry-initiated registration trials (48, 69.7%), and main roles of involvement were cooperators who plays roles under the guidance of investigators (41, 59.5%). When divided by occupation into clinical research coordinators (n = 41) and other clinical research-related personnel (n = 28), approximately half of the respondents in each group replied positively to wanting broader involvement of clinical research coordinators as a clinical research professional., Conclusion: The present study revealed that about half of the clinical research coordinators and other clinical research-related personnel view a broadening of involvement of clinical research coordinators in research activities positively. Accordingly, a structured practical program aimed at encouraging such involvement may help to expand and strengthen their contribution into the future. Whether greater involvement of clinical research coordinators in clinical research will help to ensure the reliability of investigator-initiated clinical research warrants further study., Competing Interests: The authors have no conflict of interest to disclose with respect to the present study.

Medical research is conducted by doctors as medical professionals with inspirational ideas and high ethical standards to gain knowledge for the future of medicine. Therefore, doctors must properly understand the three principles of ethics, i.e., respect for persons, beneficence, and justice, and appropriately practice them in the clinical research field. The Japan Clinical Research Act was established to restore the public confidence in clinical research that has been lost due to repeated research misconduct. Rather than being pessimistic towards the legal regulation of research, we should initiate a discussion regarding a framework to effectively utilize the evidence obtained in clinical research conducted under the law that could lead to innovative medical development. Amid changes in the global environment surrounding clinical research, we must continue generating evidence from our country, Japan, where medical resources are extremely limited, via high-quality clinical research with ethical validity and scientific rationality.