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.

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 Budgeting of non-commercial clinical trials: development of a budget tool by a public funding agency

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Hilde Nevens ◽  
Jillian Harrison ◽  
France Vrijens ◽  
Leen Verleye ◽  
Nelle Stocquart ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Selection Process ◽  
Necessary Condition ◽  
Funding Agency ◽  
Published Data ◽  
Close Monitoring ◽  
High Quality ◽  
Cost Drivers ◽  
Pragmatic Clinical Trials

Abstract Background Investigator-led multicentre randomised trials are essential to generate evidence on the optimal use of medical interventions. These non-commercial trials are often hampered by underfunding, which may lead to difficulties in gathering a team with the necessary expertise, a delayed trial start, slow recruitment and even early trial discontinuation. As a new public funder of pragmatic clinical trials, the KCE Trials programme was committed to correctly pay all trial activities in order to assure timely delivery of high-quality trial results. As no appropriate trial budget tool was readily publicly available that took into account the costs for the sponsor as well as the costs for participating sites, we developed a tool to make the budgeting of a clinical trial efficient, transparent and fair across applicants. Methods All trial-related activities of the sponsor and sites were categorised, and cost drivers were identified. All elements were included in a spreadsheet tool allowing the sponsor team to calculate in detail the various activities of a clinical trial and to appreciate the budget impact of specific cost drivers, e.g. a delay in recruitment. Hourly fees by role were adapted from published data. Fixed amounts per activity were developed when appropriate. Results This publicly available tool has already been used for 17 trials funded since the start of the KCE Trials programme in 2016, and it continues to be used and improved. This budget tool is used together with additional risk-reducing measures such as a multistep selection process with advance payments, a recruitment feasibility check by sponsor and funder, a close monitoring of study progress and a milestone-based payment schedule with the last payment made when the manuscript is submitted. Conclusions The budget tool helps the KCE Trials programme to answer relevant research questions in a timely way, within budget and with high quality, a necessary condition to achieve impact of this programme for patients, clinical practice and healthcare payers.

scholarly journals The evolution of clinical trials: Can we address the challenges of the future?

2018 ◽  
Vol 15 (1_suppl) ◽  
pp. 27-32 ◽  
Author(s):  
Hans-Georg Eichler ◽  
Fergus Sweeney
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Precision Medicine ◽  
External Validity ◽  
Pragmatic Trials ◽  
The Future ◽  
Meaningful Data

The authors describe key challenges facing the clinical trials community and propose solutions to these issues, including the role the Clinical Trials Transformation Initiative can play in addressing these issues. Specifically, the authors reflect on clinical trial globalization and the harmonization of frameworks and requirements across regions; the challenges associated with balancing the desire for external validity, pragmatic trials, and precision medicine; clinical trial transparency; and operational complexity and the expense of clinical trials. By addressing these challenges, future clinical trials will be more feasible, relevant, and credible, and support both the continuing altruistic contributions of patients and the collection of more meaningful data.

scholarly journals Clinical Trials and the Drive to Material Standardisation

2017 ◽  
pp. 30-44 ◽  
Author(s):  
Catherine M. Montgomery
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
External Validity ◽  
Three Dimensions ◽  
Material Objects ◽  
Pragmatic Trials ◽  
Positive Effects ◽  
Ethnographic Data ◽  
The Uk

There have long been calls to reduce the bureaucratization of clinical trials and make them more ‘sensible’, with the focus on approvals and guidelines. Here, I focus on the mundane environments of a multi-centre clinical trial to ask how ‘sensible’ it is to standardize trials at the level of material objects. Drawing on ethnographic data collected in the UK, South Africa and Vietnam, I present three vignettes of material standardisation. While acknowledging some positive effects, I argue that standardising in this way may be antithetical to sustainable and relevant clinical research.  Three dimensions of this are discussed: 1) the external validity of evidence from pragmatic trials 2) the gap between experimentation and implementation and 3) long-term site capacity to conduct research.  Drawing on the literature on ‘situated standardisation’, the paper concludes by suggesting a greater acknowledgement of the need for trials not only to be ‘sensible’ but also ‘situated’.

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.

scholarly journals INTEREST GROUP SESSION—ALZHEIMER'S DISEASE AND RELATED DIMENTIAS: OPPORTUNITIES AND CHALLENGES TO DEVELOPING AND TESTING PRAGMATIC ADRD INTERVENTIONS

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S363-S363
Author(s):  
Abraham A Brody ◽  
Laura N Gitlin
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Real World ◽  
Psychological Symptoms ◽  
Wide Spectrum ◽  
Pragmatic Trial ◽  
Intervention Development ◽  
Pragmatic Trials ◽  
Pragmatic Clinical Trials

Abstract Many clinical trials have been performed to develop the evidence for caring for persons with Alzheimer’s Disease and Related Disorders (ADRD) in tightly controlled settings. These trials have found efficacy of a wide spectrum of interventions to address issues from advanced care planning to behavioral and psychological symptoms of dementia (BPSD). However, few ADRD interventions have been tested in wide-scale pragmatic fashion in long term supportive settings (LTSS) such as nursing homes, primary care clinics, hospices, or community based organizations. This is due to a variety factors, principle amongst them are the difficulty in implementing pragmatic trials, and that many of the interventions developed in tightly controlled settings are not directly translatable to real-world settings. Without translating and testing interventions in real world settings, the evidence base remains largely inaccessible to the end user, the persons with ADRD and their caregivers. Moreover, effectiveness remains unclear. The lack of pragmatic trials in ADRD exists despite significant recent investment from the NIH Office of the Director in a health systems collaboratory to support pragmatic clinical trials. In 2018, NIA therefore released a call for 2-phase intervention development and pragmatic trial testing via an R61-R33 mechanism (PAR-18-585). Four proposals were funded in September 2018 from this PAR. This symposium will explore the opportunities and challenges present in developing and testing pragmatic interventions in ADRD in LTSS. The speakers will also share specific scientific methodological and implementation questions that need to be addressed in applying for pragmatic trial awards.

scholarly journals Principles and procedures for data and safety monitoring in pragmatic clinical trials

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Gregory E. Simon ◽  
Susan M. Shortreed ◽  
Rebecca C. Rossom ◽  
Robert B. Penfold ◽  
Jo Ann M. Sperl-Hillen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pragmatic Trial ◽  
Mental Health Research ◽  
Study Data ◽  
Research Network ◽  
Pragmatic Trials ◽  
Study Staff ◽  
Pragmatic Clinical Trials ◽  
Effective Delivery ◽  
Trial Monitoring

Abstract Background All clinical trial investigators have ethical and regulatory obligations to monitor participant safety and trial integrity. Specific procedures for meeting these obligations, however, may differ substantially between pragmatic trials and traditional explanatory clinical trials. Methods/Results Appropriate monitoring of clinical trials typically includes assessing rate of recruitment or enrollment; monitoring safe and effective delivery of study treatments; assuring that study staff act to minimize risks; monitoring quality and timeliness of study data; and considering interim analyses for early detection of benefit, harm, or futility. Each of these responsibilities applies to pragmatic clinical trials. Just as design of pragmatic trials typically involves specific and necessary departures from methods of explanatory clinical trials, appropriate monitoring of pragmatic trials typically requires specific departures from monitoring procedures used in explanatory clinical trials. We discuss how specific aspects of pragmatic trial design and operations influence selection of monitoring procedures and illustrate those choices using examples from three ongoing pragmatic trials conducted by the Mental Health Research Network. Conclusions Pragmatic trial investigators should not routinely adopt monitoring procedures used in explanatory clinical trials. Instead, investigators should consider core principles of trial monitoring and design monitoring procedures appropriate for each pragmatic trial.

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.

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