Current Situation with Clinical Trials in Russia
April 20, 2022
As of mid-April 2022, international pharmaceutical companies and CROs continue to fulfill their obligations to patients enrolled in already initiated clinical trials in the Russian Federation.
In order to ensure the safety of life and health of patients, and to maintain international standards for clinical trials, sponsoring companies and CROs are under pressure to actively redesign the core processes of all ongoing international projects. In particular, logistics flows are constantly being updated and optimized to ensure that trials participants have access to drugs. Issues of analyses of biological material in local laboratories are being solved to maintain full data collection capabilities, etc.
However, some questions still remain open. For example, § 34 of the Declaration of Helsinki states that trials participants should be able to access the therapy they require if it is found to be of benefit thereto in course of the trial. The standard practice for ensuring such access was to launch a new trial in which only those patients who had previously been part of a project to study the drug effectiveness could be included. There is debate within the industry about how, in the current situation, companies will be able to make the drug available to those patients who are in dire need of it after the trial is completed.