Skip to main content

Main menu

  • Home
  • COVID-19
    • Articles & podcasts
    • Blog posts
    • Collection
    • News
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • Classified ads
  • Authors
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
  • CMA Members
    • Overview for members
    • Earn CPD Credits
    • Print copies of CMAJ
    • Career Ad Discount
  • Subscribers
    • General information
    • View prices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN

User menu

Search

  • Advanced search
CMAJ
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN
CMAJ

Advanced Search

  • Home
  • COVID-19
    • Articles & podcasts
    • Blog posts
    • Collection
    • News
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • Classified ads
  • Authors
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
  • CMA Members
    • Overview for members
    • Earn CPD Credits
    • Print copies of CMAJ
    • Career Ad Discount
  • Subscribers
    • General information
    • View prices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
  • Visit CMAJ on Facebook
  • Follow CMAJ on Twitter
  • Follow CMAJ on Pinterest
  • Follow CMAJ on Youtube
  • Follow CMAJ on Instagram
News

Europe proposes laxer regulation of clinical trials

Tiago Villanueva Gutierrez Arruda Marques
CMAJ November 06, 2012 184 (16) E829-E830; DOI: https://doi.org/10.1503/cmaj.109-4302
Tiago Villanueva Gutierrez Arruda Marques
Lisbon, Portugal
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Responses
  • Metrics
  • PDF
Loading

The culprit is an 11-year-old creature known as the European Commission’s Clinical Trials Directive that apparently creates a mountain of bureaucratic red tape and overly stringent oversight, leading to an average 152-day delay in the start of trials.

The consequence, many companies and researchers say, has been a substantial decline in the number of applications to conduct clinical trials in the European Union — to 3800 in 2011 from 5028 in 2007 — as companies bailed for countries in which the rules are more industry friendly.

Faced with the fallout, the European Commission is proposing to substantially overhaul the clinical trials environment on the continent so that it features a more streamlined, centralized and harmonized application procedure; a more “risk-based” approach to regulation that reduces industry’s reporting and insurance requirements; and reduced costs for both pharmaceutical firms, who sponsor 60% of trials on the continent, and academics and other organizations, who pick up the tab for the remaining 40%.

The Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (http://ec.europa.eu/health/files/clinicaltrials/2012_07/proposal/2012_07_proposal_en.pdf) is expected to take effect in 2016 and stem the drift of trials to less-regulated environments with larger patient pools.

It is “built for success — restoring Europe’s reputation as an attractive place for clinical trials, and ensuring the protection of health, safety, rights and well-being of patients and the reliability of data generated,” Frédéric Vincent, spokesperson for health and consumer policy at the European Commission, writes in an email.

Figure1

The number of applications to conduct clinical trials in the European Union declined to 3800 in 2011 from 5028 in 2007.

Image courtesy of © 2012 Thinkstock

The overhaul allows for a “single portal” for submitting applications, to be managed by the commission, rather than a “patchwork of 27 national frameworks.” The assessment procedure for a multination, multisite trial would be coordinated by a “reporting Member State,” proposed by the trial sponsor. Ethical issues such as informed consent or the adequacy of trial sites, as well as liability issues, would be decided at the national or local level, as long as the assessment procedure is independent and complies with international standards.

Some clinicians believe the end result will be more ready access to new products and suitable treatments.

“There is high need for more involvement and facilitated streamlined recruitment of patients into clinical trials. This should be a matter of routine, whenever there is uncertainty about choice of treatment (which is frequent in primary care),” Dr. Paul Van Royen, dean of the Faculty of Medicine and Health Sciences at the University of Antwerp in Belgium, writes in an email.

But others worry that Europe is lowering its ethical bar. “With the differentiation between a centralized assessment and a decentralized assessment under the wing of each Member State, there’s no longer a clear synthesis between the ethical border and the scientific border,” Dr. António Vaz Carneiro, professor of medicine and head of the Center for Evidence Based Medicine in the Faculty of Medicine at the University of Lisbon in Portugal, writes in an email. “This differentiation can be problematic in itself, since it could create difficult problems to overcome. After all, the ethical assessment has to bear in mind the scientific aspects. Bad clinical research is always anti-ethical.”

Others, such as Dr. Eva Hummers-Pradier, professor of general practice/family medicine at the University Medicine Göttingen in Germany and chairperson of the European General Practice Research Network, say that while the proposal lays the groundwork for a less onerous approach to oversight, “time limits must be appropriate to allow for thorough reviewing by experts. In the current text, there are lots of different deadlines, which is not really feasible. And many are very short. This could potentially result in a lack of rigorous review and put patients (and science) into danger.”

The proposal alters some reporting requirements, for example, by allowing for direct reporting of unexpected adverse reactions by the trial sponsor to a central European database. In the past, trial sponsors notified authorities in each member state, who then were responsible for reporting to the database. The revisions also allow for electronic submission of annual safety reports to the European Medicines Agency.

It also allows certain types of adverse events to be exempt from reporting requirements if specified by the clinical trial protocol. The overhaul permits European Commission inspection of clinical trial sites and waives the need for trial sponsors to provide trial-specific compensation to people who suffer adverse events during trials “where there is no additional risk or where that additional risk is neglible.” But it would require member states to establish some manner of “national indemnification mechanism” if trials pose a high risk to patients.

Some European organizations stress the need for fine-tuning. “Further guidance is needed to clarify the extent of patients’ involvement, the terminology used by the Commission in the proposal, and the workings of some of the provisions contained therein, e.g. regarding co-sponsorship, risk adaptation and safety reporting,” Monika Kosinska, secretary general of the European Public Health Alliance, writes in an email. “The relationship with evolving pieces of EU [European Union] legislation such as data protection and relevant databases must also be clear to ensure that research results can be disclosed for the benefit of patients.”

PreviousNext
Back to top

In this issue

Canadian Medical Association Journal: 184 (16)
CMAJ
Vol. 184, Issue 16
6 Nov 2012
  • Table of Contents
  • Index by author

Article tools

Respond to this article
Print
Download PDF
Article Alerts
To sign up for email alerts or to access your current email alerts, enter your email address below:
Email Article

Thank you for your interest in spreading the word on CMAJ.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Europe proposes laxer regulation of clinical trials
(Your Name) has sent you a message from CMAJ
(Your Name) thought you would like to see the CMAJ web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
Europe proposes laxer regulation of clinical trials
Tiago Villanueva Gutierrez Arruda Marques
CMAJ Nov 2012, 184 (16) E829-E830; DOI: 10.1503/cmaj.109-4302

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
‍ Request Permissions
Share
Europe proposes laxer regulation of clinical trials
Tiago Villanueva Gutierrez Arruda Marques
CMAJ Nov 2012, 184 (16) E829-E830; DOI: 10.1503/cmaj.109-4302
Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
  • Responses
  • Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • Women experts underrepresented in pandemic coverage
  • What’s important to know about the new COVID-19 variants?
  • Feds update immunization advice with Moderna vaccine approval
Show more News

Similar Articles

Collections

  • Topics
    • Research methods & statistics
    • Pharmacology & toxicology

Content

  • Current issue
  • Past issues
  • Collections
  • Sections
  • Blog
  • Podcasts
  • Alerts
  • RSS
  • Early releases

Information for

  • Advertisers
  • Authors
  • Reviewers
  • CMA Members
  • Media
  • Reprint requests
  • Subscribers

About

  • General Information
  • Journal staff
  • Editorial Board
  • Governance Council
  • Journal Oversight
  • Careers
  • Contact
  • Copyright and Permissions

Copyright 2021, Joule Inc. or its licensors. All rights reserved. ISSN 1488-2329 (e) 0820-3946 (p)

All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association or its subsidiaries.

Powered by HighWire