scholarly journals The Current Status and Future Direction of Clinical Research in Japan From a Regulatory Perspective

2022 ◽  
Vol 8 ◽  
Author(s):  
Hideki Maeda
Keyword(s):  
Clinical Trials ◽  
Clinical Study ◽  
Clinical Research ◽  
Personal Information ◽  
Human Subjects ◽  
Legal Framework ◽  
Current Status ◽  
Biological Research ◽  
Marketing Approval ◽  
Ethical Guidelines

In Japan, a law called the Clinical Trials Act went into being effective on April 1, 2018, and clinical research on human subjects conducted in Japan has been undergone major changes. Those other than clinical trials for marketing approval of drugs or medical devices are broadly classified into “specific clinical trials” and others, and regulations have been tightened for each. As a result, clinical interventional study was drastically reduced, and observational clinical study increased. For the observational clinical study, the two previous ethical guidelines were merged into the “Ethical Guidelines for Medical and Biological Research Involving Human Subjects,” which was enacted in March 2021. The observational clinical study is now subjected to these ethical guidelines. In addition, changes are planned for the Act on the Protection of Personal Information, which greatly affects data collection in clinical research. Clinical research in Japan must be conducted appropriately while adapting to these various changes in the external environment and legal framework. Adapting to these changes is not an easy task, as it requires increased financial and human resources for all stakeholders.

scholarly journals Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic

2021 ◽  
Vol 11 (3-4) ◽  
pp. 181-195
Author(s):  
Anetta Jedličková
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Human Subjects ◽  
Subject Matter Experts ◽  
Ethical Challenges ◽  
Wide Audience ◽  
Ethical Implications ◽  
The Subject ◽  
Research Professionals ◽  
Trial Participants

Abstract The current coronavirus disease 2019 (COVID-19) pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and study protocol modifications may significantly impact ethically salient fundamentals, such as the risk-benefit profile and safety of clinical trial participants, which raise key ethical challenges the subject-matter experts must face. This article aims to acquaint a wide audience of clinical research professionals, ethicists, as well as the general public interested in this topic with the legal, ethical and practical considerations in the field of clinical trials during the COVID-19 pandemic and to support the clinical researchers and study sponsors to fulfil their responsibilities in conducting clinical trials in a professional way that does not conflict with any legal or ethical obligations.

scholarly journals The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic

2020 ◽  
Vol 54 (6) ◽  
pp. 1461-1472
Author(s):  
L. Horavova ◽  
K. Nebeska ◽  
L. Souckova ◽  
R. Demlova ◽  
P. Babula
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Healthcare Providers ◽  
Paediatric Population ◽  
Current Status ◽  
Therapeutic Area ◽  
Healthcare Provision ◽  
Non Profit ◽  
Pharmaceutical Industries ◽  
Design Characteristics

Abstract Introduction Paediatric non-commercial interventional clinical trials (NICTs) are crucial for healthcare provision. In spite of the fact that current regulations and initiatives try to enhance the quantity and quality of paediatric NICTs, there are still shortcomings that need to be addressed in order to accelerate the conduct of relevant clinical trials in children. To improve the current landscape of paediatric clinical research, it is necessary to identify and analyse the main trends and shortcomings, along with their impact on national performance in paediatric NICTs and this is the aim of this work. Method A retrospective systematic search of paediatric NICTs was performed on four international clinical trials registries. Entries were filtered by date from 01/01/2004 to 31/12/2017. Each identified paediatric NICT was screened and analysed for sponsors, funders, type of intervention, therapeutic area, design characteristics and associated publications. Results The search identified 439 unique NICTs. When stratifying the trials by enrolment ages, 86 trials were found involving the paediatric population. Most trials investigated the use of medicinal products and were focused on cancer or cardiovascular diseases. The most common sources of the funding were non-profit organizations. Furthermore, from the total number of completed trials, only half of them already published their results. Conclusion The main shortcomings—specifically, ethical, methodological and, in particular, economic obstacles were identified. There is a continual need for greater support and collaboration between all major stakeholders including health policymakers, grant agencies, research institutions, pharmaceutical industries and healthcare providers at the national and international level.

scholarly journals Reporting of ethical considerations in clinical trials in Chinese nursing journals

2017 ◽  
Vol 26 (4) ◽  
pp. 973-983 ◽  
Author(s):  
Yanni Wu ◽  
Michelle Howarth ◽  
Chunlan Zhou ◽  
Xue Ji ◽  
Jiexia Ou ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Human Subjects ◽  
Journal Citation Report ◽  
Mainland China ◽  
Ethical Guidelines ◽  
Ethical Considerations ◽  
Research Papers ◽  
Technology Journal ◽  
Ethical Approval

Background: It is acknowledged that publishers now require all primary research papers to demonstrate that they have obtained ethical approval for their research. Objectives: To assess the rate of reporting of ethical approval in clinical trials in core nursing journals in mainland China. Research design: A retrospective observational study. Participants: All clinical trials published in all of the 12 core nursing periodicals from 2016 edition China Science and Technology Journal Citation Report (core version) between 2013 and 2016 were retrieved by hand to explicate rate of reporting ethical approval and informed consent. Ethical considerations: The study did not require approval from the research ethics committee as it did not involve human subjects or records. Results: In total, 40,278 papers were published in 12 nursing periodicals between 2013 and 2016. Out of these, 9488 (23.6%) focused on clinical trials. Informed consent obtained from patients or the legally authorized representative was reported in 51.8% of clinical trials. Notably, only 27.4% of clinical trials reported that they had obtained written consent. Furthermore, 25.9% of clinical trials described ethical approval; however, the rate of reporting informed consent and ethical approval in these 12 nursing journals in China during 4 years from 2013 to 2016 improved markedly, with 38.1%, 44.0%, 59.0% and 66.6%, respectively ( p < 0.001), and 17.6%, 21.9%, 28.6% and 35.8%, respectively ( p < 0.001). In addition, both reporting informed consent and reporting written informed consent had a positive significant correlation with the reporting ethical approval ( p < 0.05 or < 0.01). Conclusion: Chinese scientific nursing journals have improved the rate of reporting informed consent and ethical approval in clinical trials during the last 4 years. However, it should be noted that nearly half of clinical trials still did not report either ethical approval or whether informed consent was obtained. Efforts from editors, researchers, sponsors and authors are needed to ensure the transparency of ethical scrutiny and adherence to ethical guidelines in publishing clinical trials in Chinese nursing journals.

scholarly journals Ethics in clinical research

2012 ◽  
Vol 3 (3) ◽  
pp. 16-20 ◽  
Author(s):  
Md Fakruddin ◽  
Abhijit Chowdhury ◽  
Md Nur Hossain ◽  
Khanjada Shahnewaj Bin Mannan
Keyword(s):  
Clinical Research ◽  
Human Subjects ◽  
Second World War ◽  
Ethical Review ◽  
Ethical Guidelines ◽  
Nuremberg Code ◽  
The World ◽  
Long Time ◽  
History Of ◽  
Second World

History of unethical clinical research practice date back to a very long time, though the most remarkable unethical clinical research was those by the Nazis during second world war, which eventually shaken the scientific community and gives birth to the first guideline of ethics in clinical research, the Nuremberg Code. Following Nuremberg code, a number of ethical guidelines has been formulated most important of which are the declaration of Helsinski. To make any research involving human subjects or samples ethically acceptable, a number of key features have to be considered by the scientists. These guidelines are internationally accepted and without following these guidelines, no clinical research is acceptable in the world. Though, there are many countries in the world like Bangladesh, which don’t have any ethical guidelines of their own and thus scientists in those countries do not adhere the any ethical guideline while conducting their research. Each country should have their own ethical guidelines and each clinical research institutes should have own ethical review committee to ensure ethical clinical research. DOI: http://dx.doi.org/10.3329/bioethics.v3i3.12560 Bangladesh Journal of Bioethics 2012; 3(3):16-20

scholarly journals Ethical Regulations of Medical Research Involving Human Subjects: Exploring the Perspective of Trial Participants

2019 ◽  
Vol 9 (1) ◽  
pp. 34-49
Author(s):  
Anna Kravets
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Research ◽  
Broad Spectrum ◽  
Human Subjects ◽  
Well Being ◽  
Research Protocols ◽  
Ethnographic Data ◽  
Protection Of Human Subjects ◽  
Trial Participants

In this paper I address the question of whether the existing ethical regulations of clinical research ensure protection and well-being of human subjects. Drawing on ethnographic data gathered in Berlin, Germany, I show that German institutions which are meant to ensure the ethical validity of clinical research cannot address posed issues. It appears that these institutions (Berlin Ethik-Kommission in particular) only evaluate research protocols and do not consider the broad spectrum of processes and interactions involved in clinical research. The experience of professional human subjects, as well as the consideration of the every-day life in a clinic, shows that there is much more to clinical trials. The argument of this paper is that the inability of institutions to address protection of human subjects originates from the bureaucratic logic of their organization. Drawing on Bauman’s (1992) argument that the bureaucratic machine is characterized by separation between morality and purpose, with the example of Berlin Ethik-Kommission, I argue that the bureaucratic machine cannot be sensitive to morality and ethics, even if these are its main purposes.

scholarly journals The Investigational Clinical Center: a clinical-supportive and patient-centered trial unit model. Ten years of experience through normal and pandemic times of a large pediatric Trial Center in Italy.

2021 ◽  
Author(s):  
Giuseppe Pontrelli ◽  
Marco Ciabattini ◽  
Franco De Crescenzo ◽  
Isabella Biondi ◽  
Rossana Cocchiola ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Good Clinical Practice ◽  
Legal Framework ◽  
Patient Centered ◽  
Unit Model ◽  
Clinical Center ◽  
High Workload ◽  
Pediatric Trial

Abstract Evidence-based medicine relies on appropriately designed, conducted and reported clinical trials (CTs) to provide the best proofs of efficacy and safety for pharmacological and non-pharmacological treatments. Modern clinical research features high complexity and requires a high workload for the management of trials-related activities, often hampering physicians’ participation to clinical trials. Dealing with children in clinical research adds complexity: rare diseases, parents or legal guardian reluctance to engage and recruitment difficulties are major reasons of pediatric trials failure. However, because in pediatrics many treatments are prescribed off-label or are lacking, well-designed clinical trials are particularly needed. Clinical Trial Units (CTUs) are indeed an important asset in the implementation of clinical trials, but their support to investigators is limited to administrative and non-clinical tasks. In this paper we present the model of the Investigational Clinical Center (ICC) of the Bambino Gesù Children’s Hospital in Rome. The ICC includes clinicians supporting the Principal Investigators for clinical management of enrolled patients in compliance of Good Clinical Practice, the legal framework of Clinical Trials. Furthermore, we present ten years’ experience in pediatric clinical trials and how it has been affected in 2020 by the COVID-19 pandemic. The activity of the ICC has been evaluated according to specific metrics of performance. The ICC model offers a complete support, helping investigators, patients and their families to overcome majority of barriers linked to clinical research, even in time of pandemic. We propose this organization as an innovative model for total-supportive and patient-centered clinical trial implementation.

scholarly journals Clinical trials in the pandemic age: What is fit for purpose?

2020 ◽  
Vol 4 ◽  
pp. 58 ◽  
Author(s):  
Dan Hartman ◽  
Penny Heaton ◽  
Nick Cammack ◽  
Ian Hudson ◽  
Shawn Dolley ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Clinical Study ◽  
Clinical Research ◽  
Vulnerable Groups ◽  
Equitable Access ◽  
Fit For Purpose ◽  
Gates Foundation ◽  
And Migration ◽  
Scientific Questions

It is critical to ensure that COVID-19 studies provide clear and timely answers to the scientific questions that will guide us to scalable solutions for all global regions. Significant challenges in operationalizing trials include public policies for managing the pandemic, public health and clinical capacity, travel and migration, and availability of tests and infrastructure. These factors lead to spikes and troughs in patient count by location, disrupting the ability to predict when or if a trial will reach recruitment goals. The focus must also be on understanding how to provide equitable access to these interventions ensuring that interventions reach those who need them the most, be it patients in low resource settings or vulnerable groups.  We introduce a website to be used by The Bill & Melinda Gates Foundation, Wellcome Trust, and other funders of the COVID Therapeutics Accelerator that accept proposals for future clinical research. The portal enables evaluations of clinical study applications that focus on study qualities most likely to lead to informative outcomes and completed studies.

scholarly journals COVID-19 challenges in clinical trials

2021 ◽  
Vol 10 (6) ◽  
pp. 769
Author(s):  
Murugan Panchatcharam ◽  
Sravanthi Lakshmi Mukku
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Human Subjects ◽  
Well Being ◽  
The Past ◽  
The Face ◽  
Current Scenario ◽  
One Year ◽  
Research Organisations ◽  
Contract Research Organisations

Clinical research involves working with human subjects to answer questions relevant to their well-being in an ethical manner. The current scenario from the past one year has drastically changed the face of the clinical trials. The present COVID prevalence and simultaneously conducting the research with all the regulations and the precautions has been the difficult task for the contract research organisations (CRO).

Journey across epidemiology’s third variables: an anesthesiologist’s guide for successfully navigating confounding, mediation, and effect modification

2021 ◽  
pp. rapm-2020-101984 ◽  
Author(s):  
Joshua Levy ◽  
Rebecca Lebeaux ◽  
Brock Christensen ◽  
Tor Tosteson ◽  
Yvon Bryan
Keyword(s):  
Clinical Trials ◽  
Clinical Study ◽  
Clinical Research ◽  
Patient Outcomes ◽  
Clinical Studies ◽  
Effect Modification ◽  
Medical Interventions ◽  
Patient Health ◽  
Independent Variable ◽  
The Relationship

Observational clinical research studies aim to assess which exposures (treatments or other factors; independent variable) affect patient outcomes (dependent variable). These exposures include medical interventions in situations where clinical trials are not possible or prior to their conduct and completion. However, the assessment of the relationship between exposures and outcomes is not straightforward, as other variables may need to be considered prior to reaching valid conclusions. Here, we present three hypothetical scenarios in regional anesthesia to review the epidemiological concepts of confounding, mediation, and effect modification. Understanding these concepts is critical for assessing the design, analysis, and interpretation of clinical studies. These terms may be confusing to anesthesiologists and researchers alike, where such confusion could affect the conclusions of a clinical study, mislead the target audience, and ultimately impact patient health.

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