The State Expert Center of MoH (hereinafter – the Center) informs that in view of spread of coronavirus infection additional risks may arise at conducting clinical trials of medicinal products in Ukraine. Due to the quarantine measures implemented in the country, patients may be advised to stay away from hospitals, places of high densities of people, to limit the movement through the city because of the possible threat of infection. They may also be advised to self-isolate as a precaution or as a result of confirmed infection, so are unable to undertake required activities, envisaged by the clinical trial protocol.
This may result in increase of reports on sponsor study protocol and standard operating procedures deviation due to missed visits or changes in processes, such as dispensing of investigational medicinal product to patients.
In case of deviations from the protocol, investigators should be guided by item 9.5, Section IX of the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials approved by the MoH Ukraine Oder of 23.09.2009 № 690, as amended (hereinafter – Procedure) “The responsible investigator/investigator shall conduct clinical trial according to a clinical trial protocol. The responsible investigator/investigator may deviate from a clinical trial protocol only in case of elimination of immediate hazards to subjects without the preliminary approval of the Center. Such a deviation from a clinical trial protocol shall be documented by the investigator. A description of the deviation made, its reasons and (if applicable) suggestions concerning amendments to a clinical trial protocol shall be submitted to the sponsor” and item 4.5.4 ICH GCP, approved by the MoH Ukraine Order of 16.02.2009 № 95, as amended (“Guidelines. Medicinal Products. Good Clinical Practice. Guidelines CT-H MoHU 42-7.0: 2008”) “Investigator may deviate from the protocol or amend it to eliminate immediate hazard, which threatens the trial subjects, without prior approval/positive decision of the Expert Council/Independent Ethics Committee. The description of the deviation or change made, their reasons and, if applicable, the proposed amendment(s) to the protocol shall be provided as soon as possible to:
- a) the Expert Council/Independent Ethics Committee for consideration and approval/positive decision;
- b) the sponsor for approval;
- c) to the regulatory authority(ies), if required.”
In accordance with the above provisions, any deviations from the protocol should be noted and explained by the investigator in the source documents and notified to the sponsor and Ethics Committee at health care setting. The sponsor (sponsor’s representative in Ukraine) shall notify the Center of such deviations. If necessary, the sponsor can make substantial amendments to the clinical trial materials. Such substantial amendments to the clinical trial materials shall be made in accordance with Section X of the Procedure.
An increase in study protocol deviations in relation to coronavirus will not be considered as a serious violation, so there is no need to notify this to the Center immediately (unless patients are being put at risk).
Sponsor responsibilities for control of the clinical trial, such as monitoring and audit, might need to be reassessed and alternative proportionate mechanisms of control introduced (such as phone calls, video calls, use of electronic communication devices, etc.) to ensure ongoing subject safety and well-being. We would recommend that you conduct a brief risk assessment and documentation of the impact of the risks, with consideration of prioritization of critical activities such as safety reporting. Remote monitoring can be considered; however, this should not create an extra burden on trial sites, and the subjects should give their consent to any sharing of their personal information outside the trial site, which is hereafter considered as a substantial amendment.
Safety of patients certainly shall remain a priority, and they should not be included into a clinical trial unless there is a possibility to confirm that they meet the inclusion and exclusion criteria.
Similarly, if the safety of a subject is at risk because of impossibility to complete key evaluations or adhere to critical mitigation steps, then the withdrawal of such subject from the trial should be considered. In some cases, this may extend to the entire clinical trial, the sponsor and the investigator should not forget that they can take urgent safety measures, or even temporarily halt a trial/halt recruitment of new subjects if this is the best solution to the problem. The Center should be informed of any halt, including for logistical reasons, such as trial team unavailability. This is to ensure the Center has complete oversight of status and safety for these trials.
Safety of subjects of course is a highest priority.
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