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 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.

Simple, Safe And Transparent(?): Preliminary Reflections on the Proposal for a New EU Regulation of Clinical Trials

2013 ◽  
Vol 4 (4) ◽  
pp. 534-538
Author(s):  
Marco Rizzi
Keyword(s):  
Clinical Trials ◽  
Legal Framework ◽  
Short Report ◽  
Pharmaceutical Regulation ◽  
Risk Regulation ◽  
International Context ◽  
Current Regime ◽  
Eu Regulation ◽  
Comprehensive Account ◽  
Proposed Regulation

A significant reform is currently under the scrutiny of EU institutions in the field of pharmaceutical risk regulation. With its proposal dated July 17th 2012, the Commission seeks to modernise the legal framework of clinical trials by addressing a series of shortcomings ascribed to the current regime governed by Directive 2001/20/EC (to be repealed by the new legislation). The iter of the reform is proving to be complex and lengthy, the first vote having been delayed to March 2014.While a comprehensive account of such a detailed proposal would defeat the scope of this short report, the analysis will focus on some of the most salient features of the proposed regulation, and attempt to situate them in the international context of pharmaceutical regulation.

Does the new EU Regulation on clinical trials adequately protect vulnerable research participants?

Health Policy ◽  
2015 ◽  
Vol 119 (7) ◽  
pp. 925-931 ◽  
Author(s):  
Éloïse Gennet ◽  
Roberto Andorno ◽  
Bernice Elger
Keyword(s):  
Clinical Trials ◽  
Eu Regulation ◽  
Research Participants

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.

New challenges for 21st century clinical trials

2007 ◽  
Vol 4 (2) ◽  
pp. 167-169 ◽  
Author(s):  
Richard Simon
Keyword(s):  
Clinical Trials ◽  
21St Century ◽  
New Challenges

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
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