Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Successful outcome of Voluntary Harmonisation Procedure for clinical trials in Germany

10.04.2012
Three years ago, the Voluntary Harmonisation procedure (VHP) started under the auspices of the Paul-Ehrlich-Institut (PEI). The procedure enables applicants to process authorisations of clinical trials in several European countries simultaneously.

The situation was reviewed after three years and showed a positive outcome: The time that elapses before a multinational clinical trial is authorised in all participating EU countries could be reduced to less than three months. Reports on previous experience and further steps planned by experts of the PEI can be found in the online edition of Nature Reviews Drug Discovery of 10 April 2012 (doi:10.1038/nrd3202-c2)


Time for authorisation of multinational clinical trials - changes after start of VHP. Photo: Paul-Ehrlich-Institut

The development of new and innovative medicinal products is a long and tedious process. After the preclinical phase of development, potential medicinal products have to be tested for their safety and efficacy in a number of clinical trials. In each European country where a clinical trial is planned to be performed, such a clinical trial requires a national authorisation.

If a clinical trial was to be performed in more than one European country, this meant for a long time that it had to undergo the entire procedure of validation, assessment, grounds for non-acceptance/reply, and authorisation/rejection right from the start. In the case of multinational trials with more than ten member states, it could easily take more than one year before the authorisation was obtained in all countries.

The 'Clinical Trials Facilitation Group' (CTFG), a working group of the HMA ('Heads of Medicines Agencies'), decided to remedy the situation. With the experts of the Paul-Ehrlich-Institut (PEI) being in charge, the group developed a procedure which presents a major progress both for the applicants and for the medicines agencies in Europe: The 'Voluntary Harmonisation Procedure‘ (VHP). Since March 2009 the CTFG has offered applicants who intend to perform a clinical trial in three or more EU member states the opportunity to start a single authorisation procedure in these countries.

"The verification and evaluation of clinical trials is of central importance for the development of new medicinal products. To harmonise these procedures in Europe, thus assuring a more rapid and at the same time more thorough evaluation, is a major concern for us at the PEI. I am very happy that the Paul-Ehrlich-Institut assumed a leading role in this process", said Professor Klaus Cichutek, the president of the Paul-Ehrlich-Institut.

A current evaluation shows that the procedure has in fact clearly accelerated the authorisation of multinational clinical studies: In 2011, the average period required until the authorisation of a multinational clinical trial was obtained amounted to only 82 day. Previously, it took up to several months or even one year. The actual harmonisation procedure, on the other hand takes only 50 days on average. Applicants are required to apply for an authorisation in the individual countries in which the study is to be conducted within 20 days following a favourable opinion. The deadline for such cases is now only ten days, which is feasible since all scientific questions have already been answered in the new harmonised procedure. The time period required for obtaining an authorisation of multinational clinical trials could be reduced from 124 days in the first year to currently 82 days within three years thanks to the fact that the harmonisation procedure has already undergone several revisions.– an advantage of this voluntary procedure, which requires no change in the law, and in which useful changes can be implemented on a short-term basis.

"The procedure is an important simplification for applicants and medicines agencies that assess the medicinal products. The procedures themselves are accelerated, resources of the parties involved are used in an optimum manner, and are not overburdened by double work" explained Dr Hartmut Krafft, chairman of the CTFG. This statement made in his role as an expert should be correct, since experts of the PEI coordinate all harmonisation procedures, regardless of whether the clinical trials are performed in Germany or not.

The number of applications is on the increase: In 2009, 26 applications were made. In 2011, this figure was 85, and the number is increasing further. Altogether, 170 applications have been made so far. Whereas after the introduction of VHP, the procedure was at first used by university institutions and small businesses, it is now also appreciated by large pharmaceutical companies – including companies outside Europe: More than 40% of the applications with office in the USA.

The European Commission, too, deems it necessary to harmonise the procedures. For mid-2012, a draft for a new Directive on clinical trials is expected.

Original publication:
Krafft H, Bélorgey C, Szalay G.: Experience and further development with the Voluntary Harmonization Procedure for multinational clinical trials in the European Union. 2012, doi:10.1038/nrd3202-c2

Dr. Susanne Stöcker | idw
Further information:
http://www.pei.de/
http://www.nature.com/nrd/journal/vaop/ncurrent/full/nrd3202-c2.html

More articles from Health and Medicine:

nachricht NIST scientists discover how to switch liver cancer cell growth from 2-D to 3-D structures
17.11.2017 | National Institute of Standards and Technology (NIST)

nachricht High speed video recording precisely measures blood cell velocity
15.11.2017 | ITMO University

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: A “cosmic snake” reveals the structure of remote galaxies

The formation of stars in distant galaxies is still largely unexplored. For the first time, astron-omers at the University of Geneva have now been able to closely observe a star system six billion light-years away. In doing so, they are confirming earlier simulations made by the University of Zurich. One special effect is made possible by the multiple reflections of images that run through the cosmos like a snake.

Today, astronomers have a pretty accurate idea of how stars were formed in the recent cosmic past. But do these laws also apply to older galaxies? For around a...

Im Focus: Visual intelligence is not the same as IQ

Just because someone is smart and well-motivated doesn't mean he or she can learn the visual skills needed to excel at tasks like matching fingerprints, interpreting medical X-rays, keeping track of aircraft on radar displays or forensic face matching.

That is the implication of a new study which shows for the first time that there is a broad range of differences in people's visual ability and that these...

Im Focus: Novel Nano-CT device creates high-resolution 3D-X-rays of tiny velvet worm legs

Computer Tomography (CT) is a standard procedure in hospitals, but so far, the technology has not been suitable for imaging extremely small objects. In PNAS, a team from the Technical University of Munich (TUM) describes a Nano-CT device that creates three-dimensional x-ray images at resolutions up to 100 nanometers. The first test application: Together with colleagues from the University of Kassel and Helmholtz-Zentrum Geesthacht the researchers analyzed the locomotory system of a velvet worm.

During a CT analysis, the object under investigation is x-rayed and a detector measures the respective amount of radiation absorbed from various angles....

Im Focus: Researchers Develop Data Bus for Quantum Computer

The quantum world is fragile; error correction codes are needed to protect the information stored in a quantum object from the deteriorating effects of noise. Quantum physicists in Innsbruck have developed a protocol to pass quantum information between differently encoded building blocks of a future quantum computer, such as processors and memories. Scientists may use this protocol in the future to build a data bus for quantum computers. The researchers have published their work in the journal Nature Communications.

Future quantum computers will be able to solve problems where conventional computers fail today. We are still far away from any large-scale implementation,...

Im Focus: Wrinkles give heat a jolt in pillared graphene

Rice University researchers test 3-D carbon nanostructures' thermal transport abilities

Pillared graphene would transfer heat better if the theoretical material had a few asymmetric junctions that caused wrinkles, according to Rice University...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Ecology Across Borders: International conference brings together 1,500 ecologists

15.11.2017 | Event News

Road into laboratory: Users discuss biaxial fatigue-testing for car and truck wheel

15.11.2017 | Event News

#Berlin5GWeek: The right network for Industry 4.0

30.10.2017 | Event News

 
Latest News

NASA detects solar flare pulses at Sun and Earth

17.11.2017 | Physics and Astronomy

NIST scientists discover how to switch liver cancer cell growth from 2-D to 3-D structures

17.11.2017 | Health and Medicine

The importance of biodiversity in forests could increase due to climate change

17.11.2017 | Studies and Analyses

VideoLinks
B2B-VideoLinks
More VideoLinks >>>