Due to the complicated situation of increased risk of COVID-19 and the declared State of emergency in the Republic of Bulgaria, many additional factors will influence the conduct of clinical trials in sites on the territory of the country - limited access to medical establishments, limited resources etc.
The patients’ safety and health is a main priority and the changes in the conduct of clinical trials must be based on a detailed risk assessment.
- It is recommended that not to commence new clinical trials.
- On the basis of the risk assessment it should be considered by the sponsor whether recruitment of new patients/trial subjects in ongoing clinical trials can be temporary suspended.
- The sponsor, in collaboration with the Principal Investigator, should consider if the physical visits (on-site visits) can be converted in remote tracking/visits, phone visits, postponed or canceled completely in applying the risk-based approach, the capabilities of the clinical trial’s protocol or its amendment, to ensure that only the strictly necessary visits are performed at sites. If a substantial amendment in the protocol in these cases is applied (accompanied by the relevant documentation), it will be prioritized as assessment by BDA.
- In the absence of an alternative (applying the risk-based approach), the transfer of patients from one site to another, e.g. to a new site or existing site in the same settlement, could occur. In such cases it is important to ensure the treatment continuity of the patients. Both the trial participants and the two Principal Investigators must agree on the relocation, and the receiving site must have the possibility to access previously collected information/collected data for the trial participants. In these cases a submission of substantial amendments, accompanied by the relevant documentation, is needed and will be prioritized as assessment by BDA.
- In case it is not feasible for a site to continue participation at all, the sponsor should consider if the site should be terminated and how this scan be done to best ensure patient safety and data validity. A notification to BDA is required.
- It is recommended that the medicinal products and the medical devices in the clinical trials should be maintained in appropriate quantities in order to ensure the continuity of treatment in case of difficulty in the delivery. In exceptional cases, in the case of shortages, redistribution of quantities between sites is permitted. The sponsor should guarantee that the storage conditions and the security of the delivery are ensured, following an established written procedure and documenting each stage of the process. A notification to BDA is required.
Due to the variability of clinical trials and possible cases, it is not practicable to cover all the situations. Trial subject safety in ensuring data validity and hence the quality of the clinical trial conduct, is the responsibility of the sponsor. Each stage of the process of taken measures and decisions should be documented. BDA will prioritize all questions related to COVID-19.
Regarding the monitoring of the trials - it is recommended the monitoring plan to be adjust to the sponsor procedures and the options for diluting the monitoring visits or conducting them remotely in compliance with Good Clinical Practice guidelines should be obtained.
Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic is available on the site of the European Medicines Agency (EMA):
Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic
And on the European Commission website - Eudralex Vol.10:
In case of any further questions - e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. and phone: +359 894195544
