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:9/24/2017)... ... 24, 2017 , ... In “Sky and I”, a young boy was walking home and feeling down about himself. ... him otherwise. The new friend says he can do whatever he wants to do if ... enough just the way he is. God created him with special talents and gifts. We ...
(Date:9/24/2017)... (PRWEB) , ... September 24, 2017 , ... “The Gospel Truth Of The Bible: The ... “The Gospel Truth Of The Bible: The Other Sheep” is the creation of published author, ... born in the West Indies. He has been a member of the Seventh-day Adventist ...
(Date:9/23/2017)... ... September 23, 2017 , ... Silicon Valley Hair Institute, the leading ... new blog post focused on the ARTAS® hair transplant system and the younger demographic. ... the latest, most technologically sophisticated methods of hair restoration. , “It can be emotionally ...
(Date:9/22/2017)... ... ... MEDIA OPPORTUNITY: , Save Our Hospital - Albert Lea will host media ... against Mayo Clinic. Specifically, media can talk to steering committee members and patients regarding ... the Albert Lea hospital. , The rally aims to protect the most vulnerable and ...
(Date:9/22/2017)... PA (PRWEB) , ... September 22, 2017 , ... ... soon as possible, and they often saves lives. However, if one isn’t accessible ... to widen the availability of defibrillation, I came up with this idea," said ...
Breaking Medicine News(10 mins):
(Date:9/6/2017)... -- NeuroRx, a clinical stage biopharma company developing the first ... been granted Fast Track status by the US Food and ... followed by NRX-101 (D-cycloserine + lurasidone). The company will shortly ... therapy targeting patients who are admitted to Emergency Departments with ... ...
(Date:9/5/2017)... another milestone in their continued growth and success of the company.  Xyntek has ... engagements regionally.  ... at 318 West Adams Street, Suite 1528, Chicago, IL ... Xyntek's recently opened Midwest office will support the ... In addition to Xyntek,s headquarters ...
(Date:9/5/2017)... 2017 Oramed Pharmaceuticals Inc. (NASDAQ: ... pharmaceutical company focused on the development of oral drug ... its meeting with the U.S. Food and Drug Administration ... At the meeting, ... for submission of ORMD-0801, would be a Biologics License ...
Breaking Medicine Technology:
Cached News: