Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Clinical Trials with Pharmaceuticals for Human Use - Ethical and Regulatory Aspects, Future Challenges
Frank Pietsch (Abschlußjahr: 2010)
In the year 2008 the worldwide pharmaceutical market increased by +8.2% (total of 773.2 billion) according to different sources and has to be considered as an important part of the world economic system. For the coming years it is expected that this market growth is continuing while for example Asian countries are anticipated to perform above the average. Market expectations on one hand and unmet medical needs on the other are important driving factors for medical research activities.
While GCP (Good Clinical Practise) has written a successful story as state of the art principles for clinical research other challenges still remain.
From an European perspective it is important to evaluate the own attraction regarding clinical research to maintain its reputation as well acknowledged medical research and market region.
With the exception of registering a new clinical trial into the EudraCT database all other approval processes are within the competencies of the national regulatory authorities and national ethic committees.
Ethic considerations of a new clinical trial can be influenced by several factors like medical traditions, cultural and social factors, age and sex. Also due to the potential variety of study indications and study procedures it makes senses that ethic committees evaluate each clinical trial case by case. An important part of this evaluation is the patient informed consent process, especially regarding patients who are not able to address their free will to participate in a clinical trial due to age, mental status or medical conditions in general.
Administrative burdens are resulting due to the high volume of transmitted documents within the regulatory and ethics approval process. The availability of an electronic upload of all study documents for regulatory and ethics evaluations into a database would significantly reduce paper work, speed up processes, make documents available immediately and will provide a much better overview about submitted study documents.
To provide more information about clinical trials is another aspect which is under discussion. This includes general study information and their results (negative and positive). Within the European Union plans were adopted to make selected study information of the EudraCT database available for the public. Further study information can be found on different internet pages. While making study information available for the public the question can be raised who the public is. Is it more the medical and regulatory community or patient groups and public in general? While providing study information it should be reflected who the target groups are.
Regarding regulatory approval of a clinical trial there are chances and opportunities to improve the current European and national processes. While ethical considerations should remain within each member countries responsibility more regulatory process steps could be transferred and processed on a European level. The idea here is to take more steps into the direction of establishing a kind of European clinical trial evaluation and approval with participation of the considered member states where a clinical trial is planned to be conducted.
The CTFG (Clinical Trial Facilitation Group) of the HMA (Heads of Medicine Agencies) has developed a voluntary harmonisation procedure (VHP) with the intention to transfer more regulatory processes on an European level and to shorten duration of national regulatory steps. Practical experiences are currently pending. Never the less a more centralised and streamlined European approach with transparent criteria and processes would strengthen the attraction and competitiveness of the European clinical research region.
Pages: 55, annexes 11 pages