Navigation Links
Clinical Trials Directive still hampering academic medical research
Date:9/27/2007

Barcelona, Spain: The Clinical Trials Directive, which came into force in May 2004 in order to create a harmonised framework for clinical drug research across Europe, is still hampering such research, according to new findings presented at the European Cancer Conference (ECCO 14) today (Thursday 27 September 2007). Dr. Markus Hartmann, from European Consulting and Contracting in Oncology, Trier, Germany, said that his findings confirm other observations reporting a decrease in cancer clinical trials since the introduction of the Directive, and that this was likely to turn Europe into the poor relation of clinical academic medicine.

Many sponsor organisations, commercial and non-commercial alike, have criticised the Directive for the enormous increase in administrative burdens and cost that complying with it imposes. Under the Directive, the sponsor is an individual or organisation who has to take total legal and financial responsibility for the clinical trial, including paying for the medicine(s) under investigation while patients are on the study. The reported data stagnation in numbers of trials conducted by all sponsors, despite the increasing numbers of new drug therapies tested around the world, as well as the decreasing contribution of non-commercial sponsors mirror these changes in the policies environment, said Dr. Hartmann.

Dr. Hartmann set out to examine the effect of the Directive in six of the countries that are heavyweights in clinical research with more than 500 drug trials starting each year the UK, Germany, France, The Netherlands, Italy and Spain by looking at official trial authorisation rates both prior and post the implementation of the Directive into national legislation. Trial authorisations as a quantitative parameter are much easier to assess than either improved quality of trials or better patient protection, which are also both declared aims of the Directive. The work is a first attempt to create a comprehensive picture at EU level of the outcome of the Directive three years after its coming into force, he said.

Because the follow-up time is quite short, it is still difficult to report final outcome figures, particularly given that some countries, such as France and The Netherlands, did not fully implement the Directive until 2006. But the data for non-commercial clinical research in general confirms that academic research, which represented around a quarter of all clinical trials of drugs before implementation, lost ground and represents now less than one fifth of newly started trials.

Although the size of the effect is below initially reported estimates from different sponsor organisations, the current trend remains negative. However, latest figures reported by national authorities indicate that the pre-implementation level for new clinical trial authorisations may be achieved again in the coming 12 months, at least for commercial trials.

Because the Directive changed the standards for trial reporting, many countries had to revise their way of compiling data and, as a result, the pre- and post-implementation statistics are not fully comparable. During the pre-implementation period, most authorities did not report many details. With the Directives coming-into-force, the new EudraCT database, currently only accessible by the authorities, now permits detailed analysis of the status of clinical drug research in Europe. But so far only some authorities have started to release detailed figures like research per different therapeutic indication, or per different sponsorship. In order to make this valuable data more easily available to sponsors and the research community, the European Commission, national authorities and the European Medicines Agency should improve reporting and widen public access to database statistics as part of their efforts to improve transparency, said Dr. Hartmann.

For both patients and doctors, non-commercial clinical trials offer a valuable method of defining the best place of new treatment options in medical practice. Trials conducted by acknowledged non-commercial sponsor organisations also provide for independent evaluations and comparisons of drugs, and offer urgently-needed options for access to innovative medicines in many niche indications as well as in countries with limited options of access to new drugs.

As a knowledge- and science-based society of the 21st century, Europe should not accept stagnation in an issue so relevant for biomedical competitiveness. Biomedicine is a crucial area for innovation and economic development, and policy-makers and society should have a high level of interest in promoting a competitive legal environment for medical research in line with adequate support and funding for top-level clinical research. All those involved should do their utmost to prevent a lasting cutback of interest in, commitment to, and funding for academic clinical research, said Dr. Hartmann.


'/>"/>

Contact: Mary Rice
mary@mrcommunication.org
34-932-308-832
ECCO-the European CanCer Conference
Source:Eurekalert

Related medicine news :

1. How do patients benefit of clinical trials
2. Magnetic resonance angiography in clinical medicine
3. Clinical trials need to be more frank
4. AEternas acquisition of Zentaris being followed up with its new product pipeline and clinical development strategy
5. Physicians Lack Clinical Guidelines For Treating Elderly With Multiple Illnesses
6. The Growing Rise In Clinical Research Could Lead To A Compromise In Quality Of Research And Ethics
7. Clinical Comparisons Between ADHD Drugs Are Less
8. Outsourcing clinical trials to India
9. Erectile dysfunction: an early warning sign of clinically silent coronary artery disease?
10. India to maintain Public domain Registry database of clinical trials conducted in India.
11. A Novel System For Clinical Banking Of Umbilical Cord Blood
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping ... fitness app. The fitness app plans to fix the two major problems leading the fitness ... size fits all type program , They don’t eliminate all the reasons people ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American Institutes ... Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , ... advance care planning, healthcare costs and patient and family engagement. , AIR researchers ...
(Date:6/25/2016)... Miami, FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton ... Plant City Observer , brings up a new, often overlooked aspect of head lice: ... The closing for fumigation is not a common occurrence, but a necessary one in the ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. Ogunleye ... M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Ogunleye ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a method ... —Johnson is one of the first doctors to perform the treatment. Orthobiologics are ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... June 24, 2016 The Academy of Managed ... recommendations that would allow biopharmaceutical companies to more ... that make formulary and coverage decisions, a move that ... new medicines. The recommendations address restrictions in ... on the drug label, a prohibition that hinders decision ...
(Date:6/24/2016)... According to a new market ... Needles, Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, ... of Purchase (Retail, Non-Retail) - Trends & Global Forecasts ... market for the forecast period of 2016 to 2021. ... by 2021 from USD 1.65 Billion in 2016, growing ...
Breaking Medicine Technology: