Regulation 536/2014 regarding the conduct of clinical trials will enter into force in 2019. It will be used directly in all European Union countries. Currently, there is a work under an act which is to regulate the areas that the EU legislator has left you to self-adapt and define for European countries.
However, the Ministry decided to implement the change before the implementation of Regulation 536/2014 and decided to facilitate, during this transitional period, submission of documents for application to conduct a clinical trial.
According to current law during submitting the application for conduct of a clinical trial it is mandatory to add signed contracts with all investigators and sites that are participating in a trial. Such requirement extends period of submitting full documentation by several weeks or even months, therefore the process of completing the documentation causes a delay in beginning a trial in polish sites.
Extending the start of a clinical trial results in less competitiveness of Poland compared to other European countries. That is why commercial sponsors are not willing to include Poland as a country in which clinical trial can be conducted. If a study starts it can be delayed comparing to countries where the study probably has already begun and the recruitment of patients is already under way.
Ministry has decided to move away from the requirement of submitting signed contracts with investigators and sites.
It will not be mandatory to submit signed contracts between Sponsor and sites what will cause in faster completing of documentation, submitting an application and beginning a study. Contracts will be negotiated and signed during evaluation of an application.
Instead of submitting contracts sponsor will be required to submit a financing plan for the clinical trial, a description of the compensation provided to the study participants, investigators and sites.
Thanks to such a solution, Poland will be more competitive because sponsors who conduct clinical trial simultaneously in several countries will not avoid Poland due to study delays (caused by length of documentation completion).
Text based on an interview with Ms. Ewa Rutkowska (KRK Kieszkowska Rutkowska Kolasiński) in Rzeczpospolita TV #RZECZoPRAWIE