Legal and administrative support for sponsors
Member States represent different levels of legal alignment with the regulation, Poland has a real chance in this case to become an attractive area for the development of clinical trials. There is work on the perusal law, which has a chance not so much as the possibility of comparing Poland to the Member States, but showing the attractiveness of Poland, which will attract sponsors by introducing such solutions and regulations that will distinguish Poland against the background of Europe.
Potential of Poland
The population and demography of Poland as well as the highly specialized medical staff and the excellent achievements of Polish researchers in the field of patient recruitment, research centers prepared for clinical trials are the parts that should definitely be used when preparing the law. It is important not to be a passive observer who adopts the regulation but we should actively work to remove barriers to sponsors.
Potential of new regulations
There are many issues for national regulation, including:
Legal and tax solutions that attract foreign investors eg. tax relief for R&D
Study start time It is now necessary to submit a clinical trial application together with a clinical trial contract, which prolongs the start of the trial.
Ethical evaluation of the study and the cooperation of the CA Compliance with the terms specified in the Regulation
Financing a research project
Information on clinical trials At present there is unfortunately no dissemination of information about clinical trials among humans
The new regulation will bring harmonization of procedures what will cause the Poland to be in the top ten countries in terms of receiving applications for clinical trials. These predictions are due to the demography of Poland, but in order to make our country look even more attractive and to distinguish it, it is necessary to prepare national regulations in the right way.
Afterentry into force of the Regulation 536/2014, there is a scenario whereby special regulatory divisions in CROs in a given country will be created and this country will most likely be selected as RMS and other countries will be selected only in terms of the feasibility of the conduct of trial. This is an issue that should be noted now because we will not be preparing the application as the country conducting the study and the administrative issues will not lie within our responsibility.
Regulation 536/2014 may reduce or discontinue charges in relation to non-commercial trials, the current number of those trials is only 3% in Poland, and in Western countries the number is significantly higher (even 40% of all studies are non-commercial).
Due to harmonization Investigators wishing to conduct academic research will also have to go through the central procedure and submit a an application through the EU portal, which may be a huge challenge for them.
Non-commercial studies has a different purpose than commercial research, as a rule it is an optimization of an indication that reduces the cost of healthcare or it is the treatment of rare diseases that are not the focus of pharmaceutical companies.
Non-commercial research is not just about drug research, it is also about exploring other treatments such as surgery or radiotherapy. But also the differences are that the study is designed by the investigator
More about non-commercial research read HERE.