Regulation of Clinical Trials

2021 ◽  
pp. 195-212
Keyword(s):  
Clinical Trial ◽  
European Union ◽  
Information System ◽  
Clinical Trials ◽  
Well Being ◽  
The European Union ◽  
Approval Process ◽  
Clinical Trials Regulation ◽  
Clinical Trial Information ◽  
The Eu

This chapter discusses the publication of the European Clinical Trials Directive in 2001 and its incorporation into the law of Member States. It explores the intention of the Directive in harmonising the rules for conducting clinical trials within the EU to facilitate the internal market in medicinal products and to protect the rights, safety, and well-being of participants. It also covers the passing of the new Clinical Trials Regulation (CTR) by the EU in 2014, which was prompted by concern that the system for approving clinical trials was overly bureaucratic and that it was hampering multinational trials. The CTR could not come into force until the Clinical Trial Information System (CTIS), which is intended to provide a single coordinated approval process, became fully functional. This happened too late for the CTR to be automatically incorporated into UK law by the European Union (Withdrawal) Act 2018.

Clinical Trials Regulation: A Further Step towards Increased Medical Innovation in the EU

2015 ◽  
Vol 6 (4) ◽  
pp. 646-648
Author(s):  
Anna Pavlou ◽  
Emmanuel Saurat
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
European Commission ◽  
Well Being ◽  
Medical Innovation ◽  
Eu Legislation ◽  
Clinical Trials Regulation ◽  
Clinical Trial Activity ◽  
Law Making ◽  
The Eu

On 27 May 2014, after two years of debates and extensive amendments by the EU’s law-making institutions, the EU Clinical Trial Regulation1 was published. The Regulation repeals and replaces the Clinical Trials Directive, an instrument described by the European Commission as “arguably the most heavily criticised piece of EU-legislation in the area of pharmaceuticals”. The Clinical Trials Regulation is intended to improve the existing framework, and will become applicable at the earliest on 28 May 2016. This report reviews the most significant changes to the existing system brought about by the Clinical Trials Regulation, and how this Regulation purports to strike a balance between its objective of increasing clinical trial activity in the EU and the need to protect clinical trial subjects’ rights, safety and well-being.

scholarly journals The European Clinical Trials Directive: What does this mean for the biopharmaceutical industry?

2001 ◽  
Vol 8 (1) ◽  
Author(s):  
Simon Bryson
Keyword(s):  
Clinical Trial ◽  
European Union ◽  
Clinical Trials ◽  
Good Clinical Practice ◽  
Good Manufacturing Practice ◽  
Biopharmaceutical Industry ◽  
The European Union ◽  
Qualified Person ◽  
First Time ◽  
The Eu

1st May, 2001, saw the final publication of the long-anticipated European Union Directive relating to Good clinical practice in the conduct of clinical trials on medicinal products for human use (2001/20/EC). The Directive consolidates, for the first time, aspects relating to the manufacture and provision of clinical material, clinical trial regulatory approval, and the protection of trial subjects, which encompass the conduct of clinical trials in the European Union. There are certain aspects of the directive which sow the seed of change within the pharmaceutical industry. For the first time, a qualified person will be required to perform the release of the investigational medicinal product (IMP) for use in a clinical trial. Good manufacturing practice in the manufacture of IMPs will be a legal requirement universally across the EU. This was previously dependent on member states instituting controls voluntarily. There are also changes in the pre-approval process for some biopharmaceutical products prior to trial commencement. In this paper we will explore the contents of the Directive and consider how this will impact the biopharmaceutical industry.

The European Union as an object of insecure collective attachment: A response to ‘Brexit: Who is afraid of group attachment? Part I. Europe: What Europe?’ by Arturo Ezquerro

2021 ◽  
pp. 053331642110012
Author(s):  
Antigonos Sochos
Keyword(s):  
European Union ◽  
Attachment Theory ◽  
Well Being ◽  
European Population ◽  
Insecure Attachment ◽  
The European Union ◽  
Group Attachment ◽  
Asymmetrical Power ◽  
The Eu

In this commentary I argue that the European Union has been functioning as an insecure object of collective attachment for large parts of the European population for many years. According to attachment theory, in relationships of asymmetrical power insecure attachment is formed as the narrative constructed by the most powerful party overwrites the authentic experience of the weakest, generating conflicted representation of self and the attachment object. That attachment object may be interpersonal or collective. The EU narrative on how it safeguards democracy and citizen well-being contradicts the true experience of many Europeans who struggle to make ends meet in neoliberal Europe. On this basis, an insecure collective bond with the EU is established, as the latter fails to recognize and address the needs of many of its citizens.

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.

COMMENTARY: COMBINATION THERAPY FOR ALZHEIMER’S DISEASE: PERSPECTIVES OF THE EU/US CTAD TASK FORCE

2019 ◽  
pp. 1-2
Author(s):  
E. Siemers
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
European Union ◽  
Clinical Trials ◽  
Task Force ◽  
Pharmaceutical Companies ◽  
The European Union ◽  
Combination Therapies ◽  
Regulatory Pathways ◽  
The Eu

In October 2018, the European Union-North American Clinical Trials in Alzheimer’s Disease Task Force (EU/US CTAD Task Force) met to discuss an increasingly important topic, the scientific, regulatory, and logistical challenges to the development of combination therapies for AD. Challenges related to ever-changing scientific knowledge, challenges related to complex regulatory pathways and challenges related to the necessity for pharmaceutical companies to collaborate must all be addressed. These challenges must be met since task Force members unanimously agreed that successful treatment of AD will likely require combination therapies targeting multiple mechanisms and pathways.

scholarly journals Characteristics of Medical Products Comprising Human Cells, Genes, or Tissues Developed in Japan and the European Union Compared via Public Assessment Reports

2020 ◽  
Vol 8 ◽  
Author(s):  
Ryosuke Kurauchi ◽  
Hiroi Kasai ◽  
Tatsuya Ito
Keyword(s):  
Gene Therapy ◽  
European Union ◽  
Clinical Trials ◽  
Cell Therapy ◽  
Human Cells ◽  
The European Union ◽  
Medical Products ◽  
The Eu ◽  
Assessment Reports

Medical products comprising human cells, genes, and tissues have been developed for clinical applications worldwide, and their developmental environment has been established. These products can be imported and exported, but marketing authorization regulations are complicated among regions. This investigation was conducted to identify the characteristics of medical products comprising human cells, genes, and tissues. We used website data, books from survey companies, and reports from public agencies to conduct two investigations. We used website data to conduct a general information survey of 143 cell-therapy and gene-therapy products sold in 24 countries and public assessment reports to individually survey non-clinical and clinical developments of 18 cell-therapy and gene-therapy products developed in Japan and the European Union (EU). The first survey revealed that the numbers of products used in orthopedic surgery and dermatology have increased since 2000, and the numbers of hematological products have increased since 2011. The second investigation revealed that fewer orphaned products were developed in Japan than in the EU. The most appropriate dose was 1.2 × 108 cells per injection per adult. Clinical trials to determine the most appropriate dose were conducted in the EU but not in Japan. No non-clinical immunogenicity tests for autogenous products were conducted in Japan or the EU. Pharmacokinetics tests were not individually performed for sheet-form products. Both in vivo and in vitro pharmacological tests were more likely to be conducted in the EU, while only one or the other was conducted in Japan. Furthermore, in Japan, carcinogenicity tests were performed based on non-clinical technical guidance, while in the EU, these tests were determined according to each product's features. Fewer clinical trials were performed, and fewer subjects per product were used in Japan than in the EU. Many aspects of the clinical and non-clinical development of medical products comprising human cells, genes, and tissues differ between Japan and the EU. Analyzing these differences will enable the safe and rapid distribution of these products to clinical sites.

scholarly journals Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19

2020 ◽  
Vol 51 (1) ◽  
pp. 5-13
Author(s):  
Joel Lexchin ◽  
Janice Graham ◽  
Matthew Herder ◽  
Tom Jefferson ◽  
Trudo Lemmens
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Drug Regulation ◽  
New Drugs ◽  
European Medicines Agency ◽  
Approval Process ◽  
Health Canada ◽  
Clinical Trial Information

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials is becoming more available, regulators are still reluctant to provide detailed information about how that information is interpreted. As medicines and vaccines come up for approval for treatment of COVID-19, transparency in how pivotal trials are interpreted will be critical in determining how these treatments should be used.

scholarly journals Workforce Participation, Ageing, and Economic Welfare: New Empirical Evidence on Complex Patterns across the European Union

Complexity ◽  
2022 ◽  
Vol 2022 ◽  
pp. 1-13
Author(s):  
Mirela S. Cristea ◽  
Marilen G. Pirtea ◽  
Marta C. Suciu ◽  
Gratiela G. Noja
Keyword(s):  
European Union ◽  
Labor Market ◽  
Older People ◽  
Well Being ◽  
Economic Welfare ◽  
Ageing Population ◽  
The European Union ◽  
Eu Countries ◽  
Ageing Phenomenon ◽  
The Eu

The ageing population has become one of the major issues, with manifold consequences upon the economic welfare and elderly living standards satisfaction. This paper grasps an in-depth assessment framework of the ageing phenomenon in connection with the labor market, with significant implications upon economic welfare, across the European Union (EU–27). We configure our research on four distinctive groups of the EU–27 countries based on the Active Ageing Index mapping, during 1995–2018, by acknowledging the different intensities of ageing implications on economic well-being from one group of countries to another. The methodological endeavor is based on Structural Equation Modelling. Empirical results highlight that the ageing dimensions and labor market productivity notably shape the socioeconomic development of EU countries, visibly distinguished across the four panels. The economic development induced remarkable positive spillover effects on the welfare of older people, under the influence of the ageing credentials and dynamic shaping factors. Our research advances the literature underpinnings on this multifaceted topic by investigation made on specific groups of the EU countries and distinctive strategies proposed for each group of countries, as effective results for improving the well-being of older people. Constant policy rethinking and adequate strategies should be a top priority for each specific group of EU countries, to further sustain the ageing phenomenon, with positive implications mostly on elderly welfare.

Sustainability Evaluation of the European Union based on the Ecological Footprint

2016 ◽  
Vol 19 (1) ◽  
pp. 30-40 ◽  
Author(s):  
Magdaléna Drastichová
Keyword(s):  
European Union ◽  
Human Development ◽  
Ecological Footprint ◽  
Well Being ◽  
Developed Countries ◽  
The United States ◽  
The Other ◽  
Standard Of Living ◽  
The European Union ◽  
The Eu

Abstract Recent production and consumption activities impose a heavy burden on the Earth's current and future capacity. Therefore, it is inevitable to deal with the impacts of the economic activities on the natural resources which determine our future well-being and the survival by itself. The indicators reflecting impacts of regions and countries on the available resources are used in this Paper to operationalize the sustainable development concept. The Ecological Footprint, Total Biocapacity and their components are investigated in the European Union (EU) and its countries and the EU region is compared with the other regions of the world. The additional three developed countries – Norway, Switzerland and the United States (US), were included in the sample together with the EU countries to enable extended comparisons. The aim of the Paper is to evaluate sustainability in the EU and its countries by means of the Ecological Footprint and the available biocapacity and to detect the relations between the countries’ EF and their standard of living and human development level. Concerning the regions, the highest Ecological Footprint per capita is typical of North America followed by the EU region. The Northern countries show largest biocapacities and are thus the largest resource creditors. The worst results in the Ecological Footprint – biocapacity relations analysis are typical of Cyprus, Belgium, Netherlands and Italy. The cross-section regression models confirmed that, at least, in the sample of the developed countries the positive relations between the Ecological Footprint on the one hand and the standard of living / state of the human development on the other hand exist.

scholarly journals Number of clinical trials of new therapeutic agents in the European Union countries of Central and Eastern Europe, 2000–2019

2021 ◽  
Author(s):  
Mikołaj Bartoszkiewicz ◽  
Joanna Kufel-Grabowska ◽  
Maria Litwiniuk
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Clinical Research ◽  
Eastern Europe ◽  
Central And Eastern Europe ◽  
Phase Iii ◽  
The European Union ◽  
Eu Countries ◽  
Phase Iii Trials ◽  
The Eu

Introduction: The clinical research market of the European Union (EU) countries of Central and Eastern Europe has been experiencing a dynamic growth of clinical trials in the last 10 years. Oncology and cardiology are the areas where the most clinical trials are conducted. Aim: This study aims to analyze the clinical research market including countries, medical fields and trial phases in the EU countries of Central and Eastern Europe. The comparative analysis of countries is divided into 5-year periods. Material and methods: Clinical research market analysis was carried out in 11 EU countries of Central and Eastern Europe: Bulgaria, Croatia, Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia. In searching for the number of clinical trials, the ClinicalTrials.gov database was used. Results and discussion: From 2000 to 2019, 6497 clinical trials were conducted in the EU countries of Central and Eastern Europe. There were 1840 clinical trials registered in Poland, 1188 in Czechia, and 1005 in Hungary. The most clinical trials were registered in the field of oncology (22%), followed by cardiology (16%) and neurology (12%). Phase III trials representing as much as 60% (n = 2854) of all conducted medical experiments. The highest increase in the number of clinical trials in the last two 5-year periods (2010–2014 and 2015–2019) was recorded in Estonia, at 471%. Conclusions: There has been a significant increase in the number of clinical phase III trials in the EU countries of Central and Eastern Europe, mainly in Poland, Czechia, and Hungary.

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