HOME >> MEDICINE >> NEWS
Health of independent clinical trials in danger, scientist warns

European Union legislation due to take effect next year could have a disastrous effect on non-commercial clinical trials, said a leading cancer researcher today. Speaking at ECCO 12 - The European Cancer Conference in Copenhagen, Professor Franoise Meunier, Director General of the EORTC1 Brussels, Belgium, told a news briefing that the new rules, which will have to be implemented across Europe by May 2004, will cause great harm to academic clinical trials which are designed to help patients by improving public health.

The heart of the problem lies in the definition of a trial 'sponsor'. It is defined as one individual or organisation who will take total responsibility for the clinical trial. The pharmaceutical industry can cope with this, but the definition does not take into account the partnership structure that non-commercial trials often use. The extra financial cost to the sponsor of fulfilling all the regulations in the legislation will multiply cost by a factor of 3 to 4, researchers estimate, and the administrative burden will at least be doubled.

Critics of the directive say that it was drawn up by the commission's enterprise directorate, responsible for the pharmaceutical industry, and was designed with that industry in mind, thus ignoring the needs of academics running publicly funded clinical trials.

"It is highly unlikely that any organisation involved in publicly funded research will be able to take on the role of sponsor as described in the legislation," said Prof. Meunier. "Without a sponsor, trials to conduct independent evaluations and comparison of drugs will be forced to stop, and the only clinical studies in existence will be those run by the pharmaceutical industry."

"It is vital that national authorities are made aware of this and help us to preserve independent investigations by academic researchers and co-operative groups", she said. "We hope they will be able to introduce some flexibilit
'"/>

Contact: Mary Rice
mary.rice@blueprintpartners.be
45-3252-4163
Federation of European Cancer Societies
24-Sep-2003


Page: 1 2

Related medicine news :

1. Mailman School of Public Health receives Manhattan Tobacco Cessation Center grant
2. Liverpool to lead 20M Department of Health initiative to develop medicines for children
3. Health care report cards may increase racial/ethnic disparities in bypass operations
4. 2005 Behavioral Sciences & Health Services Research Award
5. Statement on the findings of the Womens Health Study
6. Bone density returns when teens stop using Depo Provera, Group Health study finds
7. Mailman School of Public Health researchers develop infectious disease diagnostic tool
8. Health initiatives can help peace building in the Middle East
9. Study naming hospitals in top 5% for clinical quality released by HealthGrades
10. RelayHealth selected by Columbia University to link doctors and patients online
11. Health report-card fears make doctors forgo potential life-saving heart treatment

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... , ... October 13, 2017 , ... Apple Rehab ... services, staged a mock evacuation of the facility as part of a disaster drill ... Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids ... Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, ... run is geared towards children of all ages; it is a non-competitive, non-timed event, ...
(Date:10/13/2017)... ... 2017 , ... “The Journey: From the Mountains to the Mission Field”: the ... in the Philippines. “The Journey: From the Mountains to the Mission Field” is the ... She has taught all ages and currently teaches a class of ladies at her ...
(Date:10/12/2017)... ... 12, 2017 , ... Planet Fitness, one of the largest and fastest growing ... open a flagship location in Covington, LA at 401 N. U.S. Highway 190, in ... to Office Depot in the Holiday Square shopping center. Its location allows it to ...
(Date:10/12/2017)... ... , ... Asante, a nationally recognized health system in southern ... home health joint venture through an agreement, effective October 1, 2017, to create ... health company with Asante, delivering clinically integrated care, for the past eight years. ...
Breaking Medicine News(10 mins):
(Date:10/4/2017)... 2017  According to the Centers for Disease Control and Prevention (CDC), ... PhysicianOne Urgent Care is helping communities across Massachusetts , ... by offering no-cost* flu shots through the end of the month. ... insurance regulations. ... get a flu shot is by the end of October, according to ...
(Date:10/2/2017)... 2, 2017  Eli Lilly and Company (NYSE: ... the third quarter of 2017 on Tuesday, October 24, ... that day with the investment community and media to ... conference call will begin at 9 a.m. Eastern time. ... live webcast of the conference call through a link ...
(Date:10/2/2017)... -- The Rebound mobile app is poised to become a ... of prescription drug addiction. The app empowers users to develop ... down their dosage in a safe, controlled manner while maximizing ... first 100,000 people to sign up will enjoy 3 months ... ...
Breaking Medicine Technology:
Cached News: