scholarly journals Bioethics in crisis or the crisis of bioethics? : An Anthropology of Pandemic in the Medicalized Society

2021 ◽  
Author(s):  
Antonio Sandu
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Side Effects ◽  
Medical Research ◽  
Human Subjects ◽  
Standard Procedure ◽  
Herd Immunity ◽  
The European Union ◽  
Record Time ◽  
Research On Human Subjects

We will discuss (…) the need for ethics in times of crisis. Many people consider ethics and bioethics and the call for principles to be bureaucratic obstacles to obtaining a rapid response from the population, for example, to achieve vaccines in record time, to immunize the population, to establish unpopular but necessary measures, such as closing borders and non-compliance with fundamental principles of the European Union, establishing public policies aimed at herd immunity or, conversely, closing most activities considered essential in the economy, to ensure social distancing and self-isolation of the population. These measures are understood as derogations from ethics or bioethics when targeting medical research on human subjects performed faster than required by standard procedure, or the implementation of innovative therapeutic practices that have not previously been studied by clinical trials to certify that there are no known side effects.

scholarly journals EMEA and Gene Therapy Medicinal Products Development in the European Union

2003 ◽  
Vol 2003 (1) ◽  
pp. 3-8 ◽  
Author(s):  
Marisa Papaluca Amati ◽  
Francesco Pignatti ◽  
Alexis Nolte ◽  
Nirosha Amerasinghe ◽  
Daniel Gustafsson ◽  
...  
Keyword(s):  
Gene Therapy ◽  
European Union ◽  
Clinical Trials ◽  
Good Clinical Practice ◽  
Evaluation Agency ◽  
The European Union ◽  
Medicinal Products ◽  
Regulatory Processes ◽  
National Competent Authorities ◽  
Practice Implementation

The evaluation of quality, safety, and efficacy of medicinal products by the European Medicines Evaluation Agency (EMEA) via the centralized procedure is the only available regulatory procedure for obtaining marketing authorization for gene therapy (GT) medicinal products in the European Union. The responsibility for the authorization of clinical trials remains with the national competent authorities (NCA) acting in a harmonized framework from the scientific viewpoint. With the entry into force of a new directive on good clinical practice implementation in clinical trials as of 1 May 2004, procedural aspects will also be harmonized at EU level. Scientifically sound development of medicinal products is the key for the successful registration of dossiers and for contributing to the promotion and protection of public health. The objective of this paper is to introduce the EMEA regulatory processes and scientific activities relevant to GT medicinal products.

scholarly journals New regulation for clinical trials in the European Union: review and discussion

2019 ◽  
Vol 1 (30) ◽  
pp. 26-32
Author(s):  
Bakhyt Sarymsakova ◽  
◽  
Gaukhar Kuanova ◽  
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
The European Union

scholarly journals Methodological Characteristics of Clinical Trials Supporting the Marketing Authorisation of Advanced Therapies in the European Union

2021 ◽  
Vol 12 ◽  
Author(s):  
Carolina Iglesias-Lopez ◽  
Antònia Agustí ◽  
Antonio Vallano ◽  
Merce Obach
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Added Value ◽  
Life Cycle Approach ◽  
The European Union ◽  
Open Label ◽  
Advanced Therapy ◽  
Advanced Therapies ◽  
Number Of Patients ◽  
The Eu

Several advanced therapy medicinal products (ATMPs) have been approved in the European Union (EU). The aim of this study is to analyse the methodological features of the clinical trials (CT) that supported the marketing authorization (MA) of the approved ATMPs in the EU. A systematic review of the characteristics of pivotal CT of ATMPs approved in the EU until January 31st, 2021 was carried out. A total of 17 ATMPs were approved and 23 CT were conducted to support the MA (median, 1, range, 1–3). Of those studies, 8 (34.78%) were non-controlled and 7 (30.43%) used historical controls. Only 7 (30.4%) were placebo or active-controlled studies. Among all CT, 21 (91.3%) were open-label and 13 (56.52%) had a single-arm design. To evaluate the primary endpoint, 18 (78.26%) studies used an intermediate and single variable. The median (IQR) number of patients enrolled in the studies was 75 (22–118). To date, ATMPs’ approval in the EU is mainly supported by uncontrolled, single-arm pivotal CT. Although there is a trend toward an adaptive or a life cycle approach, a switch to more robust clinical trial designs is expected to better define the benefit and the therapeutic added value of ATMPs.

The Proposed EU-regulation on Clinical Trials on Medicinal Products: An Unethical Proposal?

2013 ◽  
Vol 20 (4) ◽  
pp. 347-362 ◽  
Author(s):  
Jilles Heringa ◽  
Joseph Dute
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
The European Union ◽  
Medicinal Products ◽  
Member States ◽  
Legal Documents ◽  
Human Use ◽  
Proposed Regulation ◽  
High Level ◽  
Force Member

Abstract The Commission has proposed a regulation ‘on clinical trials on medicinal products for human use’ to introduce one regulatory framework for clinical trials in the European Union. This regulation should replace the current clinical trials directive (2001/20/EC). In this article we describe and critically review the main provisions of the proposed regulation. We assess the consequences for a sound authorisation procedure of clinical trials and the level of protection for human subjects. We note that the proposed regulation is inconsistent with applicable international legal documents, such as the Biomedicine Convention and the Declaration of Helsinki. We conclude that the proposed regulation does not ensure a “high level of human health protection” — required by its legal basis in the TFEU — because it may force Member States concerned to accept a reporting Member States’ approval of — in their estimation — an unethical clinical trial.

Risk, double effect and the social benefit requirement

2020 ◽  
pp. medethics-2019-106034
Author(s):  
Robert C Hughes
Keyword(s):  
Medical Research ◽  
Human Subjects ◽  
Double Effect ◽  
Social Benefit ◽  
Social Value ◽  
Doctrine Of Double Effect ◽  
Medical Benefit ◽  
The Social ◽  
Physical Risk ◽  
Research On Human Subjects

Many ethicists maintain that medical research on human subjects that presents no prospect of direct medical benefit must have a prospect of social benefit to be ethical. Payment is not the sort of benefit that justifies exposing subjects to risk. Alan Wertheimer has raised a serious challenge to this view, pointing out that in industry, social value is not considered necessary to make dangerous jobs ethical. This article argues that Wertheimer was correct to think that the ethics of hazard pay should be the same in medical research and in business. Nevertheless, a qualified social benefit requirement should apply in both fields. For a study or a job with significant net physical risk to be ethical, it must have social value beyond the satisfaction of ordinary preferences, including the preference for money. The requirement derives from a non-absolutist version of the doctrine of double effect. If a risky study or a dangerous job has no distinctive social value, and hazard pay is subjects' or workers’ only reason to undergo risks, the very fact that they undergo risk is intended as a means to a financial end. Inviting people to enrol in such a study or to take such a job wrongfully treats people as mere means. By contrast, if a study or a job has social value, people can participate with a primary end other than money, even if they accept compensation. Researchers or employers do not intend but merely foresee risks to subjects or workers.

scholarly journals Clinical trials for authorized biosimilars in the European Union: a systematic review

2016 ◽  
Vol 82 (6) ◽  
pp. 1444-1457 ◽  
Author(s):  
Johanna Mielke ◽  
Bernd Jilma ◽  
Franz Koenig ◽  
Byron Jones
Keyword(s):  
Systematic Review ◽  
European Union ◽  
Clinical Trials ◽  
The European Union

scholarly journals Conflicts among Multinational Ethical and Scientific Standards for Clinical Trials of Therapeutic Interventions

2012 ◽  
Vol 40 (1) ◽  
pp. 99-121 ◽  
Author(s):  
Jacob M. Kolman ◽  
Nelda P. Wray ◽  
Carol M. Ashton ◽  
Danielle M. Wenner ◽  
Anna F. Jarman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
International Standards ◽  
Therapeutic Interventions ◽  
Research Subjects ◽  
Medical Sciences ◽  
Professional Groups ◽  
Department Of Health ◽  
Research On Human Subjects ◽  
Scientific Standards

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences (CIOMS), the International Conference on Harmonization's standards for industry (ICH), and the CONSORT group's reporting norms (Consolidated Standards of Reporting Trials), in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's (FDA) body of regulations, and information sheets by the Department of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”

Sign in / Sign up

Export Citation Format

Share Document