Ethical Guidelines for Clinical Trials in Mexico: Theory and Practice

2013 ◽  
pp. 217-236
Author(s):  
Emma Verástegui ◽  
Edith Váldez-Martínez
Keyword(s):  
Clinical Trials ◽  
Theory And Practice ◽  
Ethical Guidelines

scholarly journals Fair and equitable subject selection in concurrent COVID-19 clinical trials

2020 ◽  
Vol 47 (1) ◽  
pp. 7-11
Author(s):  
Maud O. Jansen ◽  
Peter Angelos ◽  
Stephen J. Schrantz ◽  
Jessica S. Donington ◽  
Maria Lucia L. Madariaga ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Research Design ◽  
Ethics Committees ◽  
Scientific Uncertainty ◽  
Moral Concern ◽  
Structural Barriers ◽  
Ethical Guidelines ◽  
Academic Medical Centre ◽  
Subject Selection ◽  
Study Results

Clinical trials emerged in rapid succession as the COVID-19 pandemic created an unprecedented need for life-saving therapies. Fair and equitable subject selection in clinical trials offering investigational therapies ought to be an urgent moral concern. Subject selection determines the distribution of risks and benefits, and impacts the applicability of the study results for the larger population. While Research Ethics Committees monitor fair subject selection within each trial, no standard oversight exists for subject selection across multiple trials for the same disease. Drawing on the experience of multiple clinical trials at a single academic medical centre in the USA, we posit that concurrent COVID-19 trials are liable to unfair and inequitable subject selection on account of scientific uncertainty, lack of transparency, scarcity and, lastly, structural barriers to equity compounded by implicit bias. To address the critical gap in the current literature and international regulation, we propose new ethical guidelines for research design and conduct that bolsters fair and equitable subject selection. Although the proposed guidelines are tailored to the research design and protocol of concurrent trials in the COVID-19 pandemic, they may have broader relevance to single COVID-19 trials.

Paediatric Research under the New eu Regulation on Clinical Trials: Old Issues New Challenges

2016 ◽  
Vol 23 (4) ◽  
pp. 325-349 ◽  
Author(s):  
Éloïse Gennet ◽  
Annagrazia Altavilla
Keyword(s):  
Clinical Trials ◽  
Implementation Process ◽  
Paediatric Research ◽  
Ethical Guidelines ◽  
Eu Regulation ◽  
Paediatric Regulation ◽  
New Challenges

Regulating paediatric research means searching for the balance between two valuable goals: protecting children while ensuring they benefit from safe and efficient medicines. Different legal instruments were adopted in the eu in order to regulate clinical trials, foster paediatric research and promote European and international ethical guidelines. However a new Regulation on clinical trials was adopted in 2014, and might change the current framework of paediatric research. How does the new Regulation 536/2014 foster research on children taking into account both the eu Paediatric Regulation and the eu Ethical Recommendations? Does it live up to the standards of the Directive 2001/20/ec and does it represent a step forward in accordance with international ethical guidelines? This article shows that, despite the adoption of new rules, many clarifications are still needed. Stakeholders involved in paediatric research have to play a driving role in the implementation process of the new Regulation.

scholarly journals PO 8490 PROMOTING GOOD DATA MANAGEMENT PRACTICES IN CLINICAL RESEARCH IN RESOURCE-POOR SETTINGS

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A45.1-A45
Author(s):  
Harry Van Loen ◽  
Diana Arango ◽  
Hanne Landuyt ◽  
Christophe Burm ◽  
Yven Van Herrewege
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Data Management ◽  
Capacity Building ◽  
Management Practices ◽  
Theory And Practice ◽  
Sub Saharan Africa ◽  
The South ◽  
Good Data ◽  
Resource Poor

BackgroundAccurate and timely data management (DM) is of key importance in clinical research to generate high-quality and GCP-compliant data for analysis and/or sharing. Our objective is to strengthen the capacity for DM in clinical research in resource-poor settings by organising several teaching initiatives.MethodsOur teaching initiatives have a twofold approach. First, a generic and comprehensive approach with capacity building on various thematical modules. These include a research component (overviewing the research data management procedures) and a technological component (introducing databases and software). In addition, a component on legislation, guidelines and standards specific towards DM is discussed, as well as a project management component on how to organise DM efficiently and timely. Second, we apply a more focused and study-specific approach which details roles and responsibilities in data management, milestones and documentation practices. Both approaches are based upon successful implementation in EDCTP-funded clinical trials, such as the 4ABC, PREGACT and Microbicide Safety Biomarkers studies, as well as the FP7 sponsored NIDIAG project. The target audience comprises various study stakeholders such as data managers, IT administrators, clinicians, laboratory researchers and statisticians, coming from sub-Saharan Africa, South-East Asia and Latin America.ResultsA teaching model for promoting Good Data Management Practices has been developed with theory- and practice-based modules. This model is used at face-to-face workshops in remote settings and has been re-used by colleagues and implemented by other research institutions to promote further capacity building and sustainable development in the South. In addition, it has led to mutual learning and enhanced institutional and personal North-South collaborations.ConclusionThere is a clear case for promoting DM and providing guidelines for Good Data Management Practices. Our twofold approach has enabled the successful conduct of GCP compliant non-commercial clinical trials in the South.

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 Legal regulations, ethical guidelines and recent policies to increase transparency of clinical trials

2020 ◽  
Vol 86 (4) ◽  
pp. 679-686 ◽  
Author(s):  
Jan Borysowski ◽  
Agata Wnukiewicz‐Kozłowska ◽  
Andrzej Górski
Keyword(s):  
Clinical Trials ◽  
Legal Regulations ◽  
Ethical Guidelines

The Protection of the Person is Central in CIOMS International Ethical Guidelines

2014 ◽  
Vol 3 (4) ◽  
pp. 270-272
Author(s):  
Michel Vallotton ◽  
Sian Fluss ◽  
Gian Sjolin Forsberg
Keyword(s):  
Clinical Trials ◽  
Selection Criteria ◽  
Meta Analysis ◽  
Epidemiological Studies ◽  
Nongovernmental Organization ◽  
Evidence Based ◽  
Ethical Guidelines ◽  
The Subject ◽  
Based Medicine ◽  
And Storage

In this brief article the authors report on the objectives of this nongovernmental organization and, most particularly, on the protection of the person in its International Ethical Guidelines for the fields of clinical trials and epidemiological studies. They emphasize the terminology used to describe the subjects or the populations involved in these studies. They discuss the possibility and nature of harm to persons involved in such studies, and justify the requirement for informed consent also for the persons involved in epidemiological studies. Finally, they consider the roles of such trials and studies as the basis for evidence-based medicine, including cases when their results are pooled in meta-analysis. This methodology is the subject of examination by a CIOMS Working Group of  problems concerning identification and selection criteria, analysis and interpretation of results (including unpublished results), and storage of data.

scholarly journals Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments

Gut ◽  
2020 ◽  
pp. gutjnl-2020-320690
Author(s):  
Klaus Gottlieb ◽  
Marco Daperno ◽  
Keith Usiskin ◽  
Bruce E Sands ◽  
Harris Ahmad ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Statistical Power ◽  
Scoring Systems ◽  
Academic Community ◽  
Theory And Practice ◽  
Outcome Instrument ◽  
Inflammatory Bowel

Central reading, that is, independent, off-site, blinded review or reading of imaging endpoints, has been identified as a crucial component in the conduct and analysis of inflammatory bowel disease clinical trials. Central reading is the final step in a workflow that has many parts, all of which can be improved. Furthermore, the best reading algorithm and the most intensive central reader training cannot make up for deficiencies in the acquisition stage (clinical trial endoscopy) or improve on the limitations of the underlying score (outcome instrument). In this review, academic and industry experts review scoring systems, and propose a theoretical framework for central reading that predicts when improvements in statistical power, affecting trial size and chances of success, can be expected: Multireader models can be conceptualised as statistical or non-statistical (social). Important organisational and operational factors, such as training and retraining of readers, optimal bowel preparation for colonoscopy, video quality, optimal or at least acceptable read duration times and other quality control matters, are addressed as well. The theory and practice of central reading and the conduct of endoscopy in clinical trials are interdisciplinary topics that should be of interest to many, regulators, clinical trial experts, gastroenterology societies and those in the academic community who endeavour to develop new scoring systems using traditional and machine learning approaches.

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