Over one hundred participants form Estonia and neighbour countries gathered to a conference „Clinical pharmaceutical research – opportunities for small and smart“ in Tallinn on November 11. The event was organised by the State Agency of Medicines and the Association of Pharmaceutical Manufacturers in Estonia with the aim of analysing the opportunities to further improve the clinical trial envronment in Estonia and in the neighbouring small EU countries.
The Estonian speakers represented academic and health care institutions and government, the guest speakers came from the Finnish health care sector, European Medicines Agency, Quintiles Clinical Operations Quality Management, UK Trade & Investment.
The first session addressed the negative trends in trials volume in the region as well as the Estonian and Finnish experience in counter-acting this. One of the changes seen in Estonia is a larger involvement of study centres outside the major tertiary care hospitals allowing to open more sites in the country per study. The session also discussed the example of the clinical trials in oncology as the treatment of choice in many cancer settings where the standard has not been set yet due to lack of evidence.
The second session discussed the study quality as a cornerstone for being an attractive location for trials. Fergus Sweeney provided an update from the EMA and Zoltan Varga from Quitiles explained their approach. Estonian efforts to ensure study quality, including the provison of the basic and advanced GCP trainings to the health care professionals and the measures in use in the health care institutions were presented by Toomas Marandi from the North Estonia Medical Centre.
The last session included a brief address by the Minister of Economic Affairs putting the trials in the general perspective of the export of the health care services and confirming the support of the government to the development of the environment for activities in this area. Nigel Whittle from the UK Trade & Investment described the successful integrated approach the UK has taken to encourage the clinical research. Factors potentially affecting the study activity in Estonia were thoroughly discussed by professor Mart Ustav (University of Tartu and Icosagen Group) who also pointed to the opportunities for improvement both inside the healthcare sector and in the general infrastructure of the country.
The conference provided a plenitude of suggestions including the further development of supportive networks for trials, one entry point for sponsors, better collaboration between the neighbour countries and inside the country to increase the number of study centers, further optimization of administrative procedures (Estonia has reduced the regulatory review time for Phase 2-4 trials to 30 days as opposed to the EU regular 60) as well as the better use in trials of the already well-developed IT systems in our health care. The organisers are providing a summary report of the meeting to the stakeholders shortly.
Slides of the presentations:
Trends in trials – regional and local
Clinical trials in Finland
Seppo Pakkala, Clinical Research Institute, Helsinki University Central Hospital, Finland
Role of clinical trials in professional development
Peeter Padrik, Tartu University Hopsital, Estonian Society for Medical Oncology
Are there opportunities for trials outside the big hospitals?
Kalev Karu, Medicum
Is good quality enough to win?
Trends in trial quality – European Medicines Agency Update
Fergus Sweeney, European Medicines Agency
Efforts to ensure quality – Estonian perspective
Toomas Marandi, North Estonia Medical Centre
Trends in trials and the response of the industry to ensure quality
Zoltan Varga, Quintiles
If the size is against you, does innovative thinking help?
Should the government care?
Juhan Parts, majandusminister (video, in Estonian, password at the page: Juhan Parts)
Increasing Competitiveness in Clinical Research
Nigel Whittle, UK Trade & Investment
Estonian experience: why things work or sometimes don’t
Mart Ustav, University of Tartu, Icosagen (video)
Future trends and outlook of healthcare markets - opportunity for Estonian economy
Imre Mürk, Estonian Development Fund