When you absolutely have to recruit patients on time.
Takeaways from Clinical Trials in EAEU 2019 held in St.Petersburg, Russia
On June 6-7, 2019, Svetlana Kazanskaya and Nikita Yegorov participated in a local conference “Clinical Trials in the Eurasian Economic Union (EAEU)” held in Saint Petersburg, Russia.
According to the information announced at the event, Nikita Yegorov summarized that legal acts describing the procedures of the whole clinical trial process are under development. Currently, the region is in a transition period when we have local, national legislation and some acts of EAEU that already came into force. The transition is expected to last for approximately 1.5 years. Other topics brought up at the conference were clinical trials in Belarus, data management in clinical trials, registration of medical devices in EAEU, clinical trials with monoclonal antibodies, risk management, open discussion on safety issues within clinical trials and source documentation within clinical trials.
A hot topic was on fraud in clinical trials. That is a situation when sites do not recruit but “create” patients. So, it was discussed how to identify the problem, how to minimize the effect on CRO’s reputation, what to do with fraudulent investigators, and how these events have an impact on a country’s reputation. One critical take-away that Accell can use to prevent any issues of the kind is to make its monitors warn investigators during site initiation visits that the Sponsor’s data management has a fraud evaluation system in place. That can prevent investigators from “straying” from the path.
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