Clinical trials: continued research, patient safety and perspectives in Ukraine

06/ 05/ 2022

On May 2, the EBA Clinical Trials Subcommittee member companies met with the State Expert Center of the Ministry of Health of Ukraine to discuss the situation on clinical trials during martial law. There was a discussion of such issues as remote submission of clinical trial documents/substantial amendments, options for interaction with applicants, the work of the Ethics Commissions, the procedure for conducting clinical trials, etc. The event was attended by nearly 90 representatives from more than 30 companies of the EBA Subcommittee. The participants noted the agile work of the SEC staff in these difficult times, which helped resolve many issues, listened to the needs of the industry and took a constructive position on recommendations to support sponsors in ensuring the safety of clinical trials and continuing trials. Also, in ensuring continuous submission and examination of CT materials and substantial amendments, compliance (and even reduction) of some terms of examination since the beginning of the war. Therefore, business thanks to the employees of the SEC for effective work and quick adaptation to new conditions! At the meeting, business received clarifications on the procedures for submitting clinical trial materials and significant amendments remotely. For example, we discussed remote communication and e-submission of documents/materials of clinical trials / substantial amendments, relocation of CT subjects, use of electronic signatures, as well as OneDrive, cloud technologies, etc. Besides, the application of the “consensus” provision in the practice of ethics commissions at health care facilities (HCFs) was clarified. One commission can take a decision on a clinical trial if there is a reference to a certain possibility in the standard operating procedures of the relevant HCFs involved in this trial. Among other things, it was noted that the SEC is working on the implementation of the electronic submission of substantial amendments (Order of the Ministry of Health № 538), and the implementation of some provisions of the Order regarding CT in Ukraine depends, inter alia, on the sponsors decision. The meeting also highlighted issues that need additional attention: the requirement to submit a complete package of CT documents in paper form in addition to those submitted in electronic form after the end of the martial law regime, which does not fully comply with the changes introduced by Order of the Ministry of Health №538; the list of recommended software for an electronic signature to be determined by the SEC; the issues of expediency & possibility of clinical audit, taking into account the martial law, active hostilities, and related restrictions on movement through the territory of Ukraine, etc. We also discussed the reduction of the number of CTs in Ukraine due to martial law and active hostilities in a certain area. Given the full-scale war on the territory of our state, Ukraine may long remain off the list of countries that sponsors plan to include in the CT. The EBA member companies stated that this is already happening. Currently, there is a need for comprehensive support of the CT in Ukraine by the state. In view of the above, the EBA Subcommittee experts suggest continuing the discussion together with the SEC, the Ministry of Health of Ukraine and the relevant VRU Committee on the steps to improve the conditions for conducting CT and prevent a serious reduction in a number of international researches in Ukraine. For reference: The meeting participants include Mykhailo Lobas, Deputy Director for Clinical Affairs, Hanna Guseva, Deputy Director for Legal Affairs, Taisa Herasymchuk, Director of the Preclinical and Clinical Trial Examination Department, Serhiy Rasputnyak, Head of Laboratory and Clinical Practice Audit (GLP, GSP), representatives of the Center for Administrative Services Single Window, heads of other departments and divisions. Iryna Magdik, EBA Clinical Trials Subcommittee Executive Director, participates as the representative of the European Business Association.

The event was attended by nearly 90 representatives from more than 30 companies of the EBA Subcommittee. The participants noted the agile work of the SEC staff in these difficult times, which helped resolve many issues, listened to the needs of the industry and took a constructive position on recommendations to support sponsors in ensuring the safety of clinical trials and continuing trials. Also, in ensuring continuous submission and examination of CT materials and substantial amendments, compliance (and even reduction) of some terms of examination since the beginning of the war. Therefore, business thanks to the employees of the SEC for effective work and quick adaptation to new conditions!

At the meeting, business received clarifications on the procedures for submitting clinical trial materials and significant amendments remotely. For example, we discussed remote communication and e-submission of documents/materials of clinical trials / substantial amendments, relocation of CT subjects, use of electronic signatures, as well as OneDrive, “cloud” technologies, etc. Besides, the application of the “consensus” provision in the practice of ethics commissions at health care facilities (HCFs) was clarified. One commission can take a decision on a clinical trial if there is a reference to a certain possibility in the standard operating procedures of the relevant HCFs involved in this trial. Among other things, it was noted that the SEC is working on the implementation of the electronic submission of substantial amendments (Order of the Ministry of Health № 538), and the implementation of some provisions of the Order regarding CT in Ukraine depends, inter alia, on the sponsor’s decision.

The meeting also highlighted issues that need additional attention:

the requirement to submit a complete package of CT documents in paper form in addition to those submitted in electronic form after the end of the martial law regime, which does not fully comply with the changes introduced by Order of the Ministry of Health №538;
the list of recommended software for an electronic signature to be determined by the SEC;
the issues of expediency & possibility of clinical audit, taking into account the martial law, active hostilities, and related restrictions on movement through the territory of Ukraine, etc.

We also discussed the reduction of the number of CTs in Ukraine due to martial law and active hostilities in a certain area. Given the full-scale war on the territory of our state, Ukraine may long remain off the list of countries that sponsors plan to include in the CT. The EBA member companies stated that this is already happening. Currently, there is a need for comprehensive support of the CT in Ukraine by the state.

In view of the above, the EBA Subcommittee experts suggest continuing the discussion together with the SEC, the Ministry of Health of Ukraine and the relevant VRU Committee on the steps to improve the conditions for conducting CT and prevent a serious reduction in a number of international researches in Ukraine.

For reference:

The meeting participants include Mykhailo Lobas, Deputy Director for Clinical Affairs, Hanna Guseva, Deputy Director for Legal Affairs, Taisa Herasymchuk, Director of the Preclinical and Clinical Trial Examination Department, Serhiy Rasputnyak, Head of Laboratory and Clinical Practice Audit (GLP, GSP), representatives of the Center for Administrative Services “Single Window”, heads of other departments and divisions. Iryna Magdik, EBA Clinical Trials Subcommittee Executive Director, participates as the representative of the European Business Association.