Medicines : Commission Aims to Boost Clinical Research

European Social Policy, September 19, 2012 | Go to article overview

Medicines : Commission Aims to Boost Clinical Research


Existing EU legislation on clinical trials is a failure. All stakeholders - patients, pharmaceutical laboratories and researchers - are extremely critical. In view of this fact, the European Commission proposed, on 17 July, to replace Directive 2001/20/EC with a regulation(1). Health Commissioner John Dalli wants to "reverse the trend" by simplifying procedures, making a distinction between trials in terms of risks and imposing greater transparency.

DECLINE

Research is waning in the EU: from 2007 to 2011, there was a 25% decline in clinical trials due to a regulatory framework that imposes burdensome administrative formalities, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Commission. The EU executive is fully aware of the difficulties faced by the pharmaceuticals sector and notes that staff in charge of clinical trials has had to be doubled to deal with administrative tasks. As a result, research is relocating to emerging countries (Asia, Russia and Latin America). In India, for example, more than 150,000 people are involved in at least 1,600 clinical trials being conducted by the big Western pharmaceutical firms like AstraZeneca, Pfizer and Merck, says MEP Peter Liese (EPP, Germany). Rules and controls are less strict in this country. The Independent(2) has reported that Indians sometimes participate in several clinical trials simultaneously to earn more money; some (often poor and illiterate) have even been accepted without really giving informed consent.

LESS BUREAUCRACY

Clinical trials are investigations in humans intended to discover the effects of a medicinal product based on a research protocol. One quarter of trials are multinational, especially large-scale trials and those concerning rare diseases. The procedure is bureaucratic and long, however. The proposal is meant to simplify it. The authorisation procedure will be harmonised, evaluation will be flexible and speedy, a rapporteur' member state will be appointed and precise time limits will be set. …

The rest of this article is only available to active members of Questia

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

Medicines : Commission Aims to Boost Clinical Research
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited passage

Thanks for trying Questia!

Please continue trying out our research tools, but please note, full functionality is available only to our active members.

Your work will be lost once you leave this Web page.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.