scholarly journals Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Daria Kim ◽  
Joerg Hasford
Keyword(s):  
Clinical Trials ◽  
Health Risks ◽  
Ethics Committees ◽  
Medical Community ◽  
Significant Extent ◽  
Regulatory Requirements ◽  
Trial Participants ◽  
Clinical Trials Regulation ◽  
Clinical Trial Regulation ◽  
The Eu

Abstract The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

scholarly journals Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries

2020 ◽  
Vol 29 ◽  
Author(s):  
Giovanni Ostuzzi ◽  
Chiara Gastaldon ◽  
Carlo Petrini ◽  
Brian Godman ◽  
Corrado Barbui
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
European Countries ◽  
Pragmatic Trials ◽  
Research And Practice ◽  
Major Threat ◽  
Pragmatic Clinical Trials ◽  
Clinical Trial Regulation ◽  
The Eu

Abstract The principle of pragmatism in clinical trials has been broadly recognised as a way to close the gap between research and practice. In this contribution, we argue that the conduct of pragmatic clinical trials in Europe may be hampered by poor implementation of current European Union's Clinical Trial Regulation No. 536/2014.

Challenges in Opening and Enrolling Patients in Clinical Trials

2017 ◽  
pp. 139-143
Author(s):  
Julie M. Vose ◽  
Meredith K. Chuk ◽  
Francis Giles
Keyword(s):  
Clinical Trials ◽  
Scientific Integrity ◽  
Cancer Therapies ◽  
Regulatory Requirements ◽  
Cancer Treatments ◽  
Contract Research ◽  
Trial Conduct ◽  
Slowing Down ◽  
Research Organizations ◽  
Trial Participants

Clinical trials are key elements of the processes that account for many of the recent advances in cancer care, including decreased mortality rates and increased survivorship; better supportive care; and improved understanding of cancer risk, prevention, and screening. This research also has led to the validation of numerous exciting new types of cancer treatments, such as molecularly targeted therapies and immunotherapies. Clinical trials, however, are becoming more and more challenging to conduct. Research programs must comply with legal and regulatory requirements that can be inefficient and costly to implement and often are variably interpreted by institutions and sponsors and sponsors’ representatives, including contract research organizations. Some of these requirements are essential to protect the safety of trial participants, to promote the scientific integrity of research, or to ensure that trial conduct is efficient and adequately resourced. Such requirements are important to preserve. However, some requirements do not fulfill any of these goals and, in fact, hinder research and slow patient access to safe and effective treatments. This article discusses some of the identified issues that are slowing the process of cancer clinical trials, such as conservatively interpreted guidelines by pharmaceutical companies and contract research organizations; overprotective language for contracts; and patient protections by health systems and universities. The article also discusses possible solutions to these problems that are slowing down the cancer therapies that patients need.

Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards

2020 ◽  
pp. medethics-2020-106757
Author(s):  
Vilma Lukaseviciene ◽  
Joerg Hasford ◽  
Dirk Lanzerath ◽  
Eugenijus Gefenas
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Negative Consequences ◽  
Ethics Review ◽  
Clinical Trial Directive ◽  
Favourable Environment ◽  
The Eu

The upcoming Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Regulation), which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible.

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.

The EU regulatory network and emerging trends – a review of quality, safety and clinical development programmes

2021 ◽  
Vol 10 (2) ◽  
pp. 83-99
Author(s):  
Marta Zuccarelli ◽  
Benjamin Micallef ◽  
Mark Cilia ◽  
Anthony Serracino-Inglott ◽  
John-Joseph Borg
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Phase I ◽  
Clinical Development ◽  
Phase Iii ◽  
Regulatory Requirements ◽  
Safety Concerns ◽  
Emerging Trends ◽  
Over Time ◽  
The Eu

Introduction/Study Objectives: The development of biosimilars is challenging due to the complexity of the active substances as well as the strict regulatory requirements to show similarity with a reference medicinal product. This review aims to describe the regulatory experience of approving biosimilars in the European Union (EU) within the EU framework, identify emerging trends in the EU regulatory pathway when approving biosimilars and discuss where the EU biosimilar framework is heading. Methods: Marketing authorisation applications (MAAs) submitted up to 2019 were retrieved from the public domain. The European public assessment report database was searched for approved biosimilars and clinical development programmes of biosimilars belonging to the same class were reviewed. In order to observe if biosimilars released onto the market increased safety concerns, we compared disproportionate adverse event reports pre- and post-licensure. Results: Up to December 2019, 90 MAAs were submitted and 53 biosimilars were approved for 14 different biologicals. Total number of clinical trials (both phase I and III) steadily goes up driven by an increase number of approvals in later years, while the average number of both phase I and III trials decreased over time with some with Pegfilgrastim biosimilars being approved without conducting any phase III clinical trials. No new safety concerns were identified from the analysis of disproportionate adverse event reports. Discussion: Clinical development programmes of biosimilars and the requirements set for biosimilars approval are changing over time. Biosimilars approved seem to be as well tolerated as the reference products when approved based on stringent regulatory requirements. Conclusion: Regulation of biosimilars is progressing as more knowledge is gained.

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 Dissemination of trial results to participants in phase III pragmatic clinical trials: an audit of trial investigators intentions

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e035730
Author(s):  
M Zulfiqar Raza ◽  
Hanne Bruhn ◽  
Katie Gillies
Keyword(s):  
Clinical Trials ◽  
Ethics Committees ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Integrated Research ◽  
Pragmatic Clinical Trials ◽  
Phase Iii Trials ◽  
The Uk ◽  
Dissemination Of Results ◽  
Trial Participants

ObjectiveTo determine the proportion of Phase III clinical trials given a favourable opinion by a research ethics committee in the UK that provided trial results to those who participated.DesignAudit of records.SettingPhase III clinical trials registered on the UK’s research permissions system (Integrated Research Application System) between the 1 January 2012 to 31 December 2017.Main outcome measuresProportion of trial investigators that intended to provide results to trial participants compared against what trials reported to ethics committees at the end of study.ResultsOut of 1404 Phase III trials, 87.7% (n=1231) trials stated they intended to disseminate results to participants while 12.3% (n=173) trials stated they would not. Out of these 1231 trials, 18.8% (n=231) trials intended to actively communicate trial results or a means of accessing results to their participants, a further 80.5% (n=991) reported passive intention to disseminate and for the remainder (n=9) the process was unclear. Of the 370 End of Study reports (30% of all included studies) that could be accessed 10 (2.7%) explicitly mentioned activities related to dissemination of findings to participants with the majority (74.9%) having no mention and a further 22.4% of reports not being accessible. Of the 10 which did report dissemination of results to participants the majority (n=6) were through a lay summary or letter.ConclusionsReported intention to disseminate results to trial participants among trial investigators is high, however, reporting of feedback methods is lacking. In addition, mechanisms to ensure intentions to disseminate trial results are translated into actual behaviour need to be put in place to ensure those who participate in trials have the opportunity to find out about the results.

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