Featured Research

from universities, journals, and other organizations

Unnecessary Regulation Harming Clinical Research In The UK, Say Experts

Date:
October 16, 2008
Source:
BMJ-British Medical Journal
Summary:
Increasing bureaucracy is the biggest single threat to clinical research in the UK and urgent action needs to be taken, argue experts.

Increasing bureaucracy is the biggest single threat to clinical research in the UK and urgent action needs to be taken, argue experts on the British Medical Journal website.

European legislation introduced in 2001 was intended to simplify and harmonise the regulation of trials across the European Union. But it has led to long delays in approval, is "poorly coordinated, lacks inconsistency at all levels, and at times is completely illogical", write Professors Morris Brown and Paul Stewart.

Because of the increasingly complicated and time-consuming approval process, the UK has fallen from being one of the most attractive places for the pharmaceutical industry to undertake clinical trials to one of the least attractive, warn the authors.

Main concerns of the authors include the lengthy application process—paperwork can take up to 40 hours to complete, the inconsistencies and delays in the review process, and the lack of clarity about what requires ethical approval.

According to the authors, another key problem is the ineffectiveness of the Medicines and Healthcare Products Regulatory Agency (MHRA) approval process—the application is difficult to complete, cannot be submitted online and is sometimes lost by the MHRA.

The MHRA was set up to investigate new medicinal products, but its extended responsibility to approve all clinical trials in the UK has been counterproductive, say the authors.

"The process adds long delay for no perceived benefit…No improvement in patient safety has been demonstrated as a consequence of the extra tier of bureaucracy for such studies", say the authors, "On the contrary, the MHRA failed to prevent the TeGenero disaster at Northwick Park—or acknowledge its failure".

So what needs to be done?

The recently formed National Institute of Health Research (NIHR) has already begun a "bureaucracy busting" mission, say the authors, but they outline a number of recommendations to reduce research bureaucracy.

For example, they suggest a single and simple web based submission form for all research studies, rather than a different form for every funding and governance organisation. In addition, they suggest a national and consistent ethical review process to replace the current "postcode lottery", and an automatic grading of applications which would make patient safety "self evident".

They conclude by calling for the MHRA to concentrate on its primary responsibility, and ensure that medicines work and are safe.


Story Source:

The above story is based on materials provided by BMJ-British Medical Journal. Note: Materials may be edited for content and length.


Cite This Page:

BMJ-British Medical Journal. "Unnecessary Regulation Harming Clinical Research In The UK, Say Experts." ScienceDaily. ScienceDaily, 16 October 2008. <www.sciencedaily.com/releases/2008/10/081016191816.htm>.
BMJ-British Medical Journal. (2008, October 16). Unnecessary Regulation Harming Clinical Research In The UK, Say Experts. ScienceDaily. Retrieved April 20, 2014 from www.sciencedaily.com/releases/2008/10/081016191816.htm
BMJ-British Medical Journal. "Unnecessary Regulation Harming Clinical Research In The UK, Say Experts." ScienceDaily. www.sciencedaily.com/releases/2008/10/081016191816.htm (accessed April 20, 2014).

Share This



More Science & Society News

Sunday, April 20, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Drought Concerns May Hurt Lake Tourism

Drought Concerns May Hurt Lake Tourism

AP (Apr. 18, 2014) Operators of recreational businesses on western reservoirs worry that ongoing drought concerns will keep boaters and other visitors from flocking to the popular summer attractions. (April 18) Video provided by AP
Powered by NewsLook.com
Small Reactors Could Be Future of Nuclear Energy

Small Reactors Could Be Future of Nuclear Energy

AP (Apr. 17, 2014) After the Fukushima nuclear disaster, the industry fell under intense scrutiny. Now, small underground nuclear power plants are being considered as the possible future of the nuclear energy. (April 17) Video provided by AP
Powered by NewsLook.com
Heartbleed Hack Leads To Arrest

Heartbleed Hack Leads To Arrest

Newsy (Apr. 17, 2014) A 19-year-old computer science student has been arrested in relation to a data breach of 900 social insurance numbers from Canada's revenue agency. Video provided by Newsy
Powered by NewsLook.com
Scientists Create Stem Cells From Adult Skin Cells

Scientists Create Stem Cells From Adult Skin Cells

Newsy (Apr. 17, 2014) The breakthrough could mean a cure for some serious diseases and even the possibility of human cloning, but it's all still a way off. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins