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:
Dr. Susanne Stöcker | idw
Resolving the mystery of preeclampsia
21.10.2016 | Universitätsklinikum Magdeburg
New potential cancer treatment using microwaves to target deep tumors
12.10.2016 | University of Texas at Arlington
Researchers from the Institute for Quantum Computing (IQC) at the University of Waterloo led the development of a new extensible wiring technique capable of controlling superconducting quantum bits, representing a significant step towards to the realization of a scalable quantum computer.
"The quantum socket is a wiring method that uses three-dimensional wires based on spring-loaded pins to address individual qubits," said Jeremy Béjanin, a PhD...
In a paper in Scientific Reports, a research team at Worcester Polytechnic Institute describes a novel light-activated phenomenon that could become the basis for applications as diverse as microscopic robotic grippers and more efficient solar cells.
A research team at Worcester Polytechnic Institute (WPI) has developed a revolutionary, light-activated semiconductor nanocomposite material that can be used...
By forcefully embedding two silicon atoms in a diamond matrix, Sandia researchers have demonstrated for the first time on a single chip all the components needed to create a quantum bridge to link quantum computers together.
"People have already built small quantum computers," says Sandia researcher Ryan Camacho. "Maybe the first useful one won't be a single giant quantum computer...
COMPAMED has become the leading international marketplace for suppliers of medical manufacturing. The trade fair, which takes place every November and is co-located to MEDICA in Dusseldorf, has been steadily growing over the past years and shows that medical technology remains a rapidly growing market.
In 2016, the joint pavilion by the IVAM Microtechnology Network, the Product Market “High-tech for Medical Devices”, will be located in Hall 8a again and will...
'Ferroelectric' materials can switch between different states of electrical polarization in response to an external electric field. This flexibility means they show promise for many applications, for example in electronic devices and computer memory. Current ferroelectric materials are highly valued for their thermal and chemical stability and rapid electro-mechanical responses, but creating a material that is scalable down to the tiny sizes needed for technologies like silicon-based semiconductors (Si-based CMOS) has proven challenging.
Now, Hiroshi Funakubo and co-workers at the Tokyo Institute of Technology, in collaboration with researchers across Japan, have conducted experiments to...
14.10.2016 | Event News
14.10.2016 | Event News
12.10.2016 | Event News
21.10.2016 | Health and Medicine
21.10.2016 | Information Technology
21.10.2016 | Materials Sciences