New European Union regulation of clinical trials is conflicting on deferred consent in emergency situations

BMJ ◽  
2013 ◽  
Vol 346 (feb06 1) ◽  
pp. f667-f667 ◽  
Author(s):  
C. Gamble ◽  
K. Woolfall ◽  
P. Williamson ◽  
R. Appleton ◽  
B. Young
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Emergency Situations ◽  
Deferred Consent

Prevention of Armed Attacks at Schools as a Part of Emergency Situations Didactics

2015 ◽  
Vol 5 (3) ◽  
pp. 95-112
Author(s):  
Miroslava Kovaříková
Keyword(s):  
European Union ◽  
School Management ◽  
The European Union ◽  
Security Risks ◽  
Emergency Plans ◽  
Security Issues ◽  
Emergency Situations ◽  
European Union Countries ◽  
Perception Of Security ◽  
Technical And Organizational Measures

This article deals with the issue of security management and its following application in education. The article focuses on the topic of armed attacks at schools. Based on a research probe aimed at teachers which focused on perception of security risks, there are chosen areas to which Central emergency system services should react. Further, knowledge of technical and organizational measures of emergency plans in the organization and the level of attention paid to this issue by the school management were investigated. In the text there are also international models of solutions of this issue introduced. The contribution also brings outline of how is the issue solved in the European Union countries, in particular in the Kingdom of Spain. Experience with the solution of security issues of schools in Latin America are also mentioned. In the conclusion the summary of measures for improvement of security at schools is presented.

scholarly journals A Healthy Sense of Trust

2017 ◽  
Vol 2 (Suppl. 1) ◽  
pp. 1-10
Author(s):  
Denis Horgan
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Big Data ◽  
Data Protection ◽  
Fast Moving ◽  
Ethical Issues ◽  
Personalised Medicine ◽  
Drug Pricing ◽  
The Right ◽  
The Eu

In the fast-moving arena of modern healthcare with its cutting-edge science it is already, and will become more, vital that stakeholders collaborate openly and effectively. Transparency, especially on drug pricing, is of paramount importance. There is also a need to ensure that regulations and legislation covering, for example the new, smaller clinical trials required to make personalised medicine work effectively, and the huge practical and ethical issues surrounding Big Data and data protection, are common, understood and enforced across the EU. With more integration, collaboration, dialogue and increased trust among each and every one in the field, stakeholders can help mould the right frameworks, in the right place, at the right time. Once achieved, this will allow us all to work more quickly and more effectively towards creating a healthier - and thus wealthier - European Union.

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.

scholarly journals Uninformed refusals: objections to enrolment in clinical trials conducted under an Exception from Informed Consent for emergency research

2018 ◽  
Vol 45 (1) ◽  
pp. 18-21
Author(s):  
Victoria Vorholt ◽  
Neal W Dickert
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Human Services ◽  
Emergency Research ◽  
Emergency Situations ◽  
Risks And Benefits ◽  
Department Of Health ◽  
The Us ◽  
Level Of Understanding ◽  
Practical Implications

Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent (EFIC) in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study.

scholarly journals Deutsche Universitäten machen Ergebnisse klinischer Arzneimittelstudien unzureichend öffentlich – Das sollte sich ändern

2020 ◽  
Vol 63 (12) ◽  
pp. 1531-1537
Author(s):  
Peter Grabitz ◽  
Till Brückner ◽  
Daniel Strech
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Klinische Studien ◽  
Status Quo ◽  
Öffentliche Gesundheit ◽  
Deklaration Von Helsinki

ZusammenfassungErgebnisse klinischer Arzneimittelstudien müssen nach Abschluss zeitnah und nichtselektiv veröffentlicht werden. Die Ergebnispublikation ist als zentrale ethische Regel in der Deklaration von Helsinki des Weltärztebundes festgehalten. Deutsche Universitätskliniken sind vermehrt in die Kritik geraten, diesen Anforderungen nicht ausreichend nachzukommen.In diesem Beitrag werden verschiedene Publikationsformen von klinischen Arzneimittelstudien (Fachartikel und Kurzberichte) diskutiert und der Status quo der Ergebnispublikation deutscher Universitätskliniken analysiert. Dazu wurden 3 Register und Datenbanken für klinische Studien auf Veröffentlichung von Kurzberichten geprüft: das European Union Clinical Trials Register (EUCTR), das US-amerikanische Register ClinicalTrials.gov und das rein deutschsprachige Portal PharmNet.Bund. Positionen unterschiedlicher Interessengruppen werden zusammengetragen und mögliche Schritte zur Verbesserung vorgeschlagen.Derzeit erfüllen deutsche Universitätskliniken ihre regulatorischen und ethischen Verpflichtungen im Hinblick auf die Ergebnisveröffentlichung klinischer Arzneimittelstudien nur unzureichend. Zwei Jahre nach Studienende hatten 2 Drittel der Studien, die 2010–2014 abgeschlossen wurden und auf ClinicalTrials.gov verzeichnet sind, noch keine Ergebnisse als Fachartikel veröffentlicht, im Register selbst waren nur für 4,7 % als Kurzberichte hinterlegt. Im EUCTR liegt die Publikationsrate von Kurzberichten bei weniger als 7 %. Die Untersuchung der Datenbank PharmNet.Bund zeigte Ergebnisberichte für weniger als 15 % der dortigen Einträge.Um das Abschneiden der deutschen Universitätskliniken im Bereich Ergebnispublikation von klinischen Arzneimittelstudien zu verbessern, braucht es politischen Willen und Engagement der Kliniken selbst. Die Veröffentlichung der Ergebnisse aller klinischen Studien ist mit geringen Kosten verbunden. Die Vorteile für öffentliche Gesundheit und Wissenschaft überwiegen bei Weitem den jetzt notwendigen Mehraufwand.

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