October 2020 – On 28 September 2020, the State Expert Centre of the Ministry of Health of Ukraine ("the Centre") updated its non-binding guidance on the conduct of clinical trials of medicinal products, considering the current quarantine restrictions due to the spread of COVID-19 ("the Guidance"). The Guidance was prepared on the basis of the "Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic" developed by the European Medicines Agency (version 3 dated 28 April 2020).
The full English text of the Guidance is available here.
Below we summarise the most important highlights of the updated Guidance.
On-going clinical trials. The Centre recommends limiting unnecessary visits to trial sites by participants of clinical trials. Instead, other measures may be taken, such as home nursing, if possible, and telephone or video communication (telemedicine). In such cases, trial participants shall be provided with all required resources and communication devices to ensure permanent medical aid and supervision within the course of clinical trials.
In certain cases, other measures may be considered, such as postponing or cancelling visits to trial sites; temporarily halting trials at some or all trial sites; temporarily interrupting the recruitment of new trial participants; extending the time period of the clinical trial; closing certain trial sites; or transferring trial participants to trial sites away from risk zones or closer to their home, etc. The investigator shall inform trial participants of any planned changes in advance.
The Guidance also recommends adjusting the procedure for the distribution of investigational medicinal products ("IMP") to avoid unnecessary visits to trial sites. For instance, a trial participant may be provided with more IMP than is usually provided per visit. Such changes should be carefully evaluated, and any alternative mechanisms for the organisation of IMP delivery and storage conditions should be considered. In any event, any such changes to the procedure for IMP distribution must not risk the disclosure of personal data or any confidential data in connection with such clinical trials.
In certain cases, it may be required to deliver IMP directly to a trial participant's home. If, due to the COVID-19 pandemic, a trial site is not able to handle the additional burden of IMP delivery to participants, IMP may be delivered by an independent distributor under a contract concluded with the sponsor.
Further, the Guidance recommends adjusting the procedure of monitoring clinical trials. If it is possible to limit on-site monitoring, the following alternative measures may be applied: (1) centralised monitoring and review of collected data; (2) off-site monitoring; and (3) remote source data verification. Changes to trial conduct initiated by the sponsor should be agreed with and communicated clearly to investigators. This may be done via e-mail exchange.
NB! Any changes to clinical trials must be duly documented and thereafter approved as substantial amendments under the procedure established by the applicable laws.
New clinical trials. Sponsors should critically evaluate the expediency of starting new clinical trials or the enrolment of new participants of clinical trials within on-going clinical trials. Additional risks for trial participants should be evaluated and recorded in the clinical trial's protocol (section on risks assessment).
With regard to obtaining informed consent, if it is not possible to obtain written consent from a potential trial participant (e.g., physical isolation due to COVID-19), the participant may provide verbal consent in the presence of an independent witness, subject to compliance with other formal requirements.
Clinical trials of medicinal products for the treatment or prevention of COVID-19. Protocols of clinical trials of medicinal products for the treatment of COVID-19 and any substantial amendments to them should be approved within five calendar days.
The sponsor/applicant and investigators should foresee and describe in the protocol and other materials relating to clinical trials all possible measures to minimise risks, in particular related to preventing the spread of coronavirus disease (COVID-19) among participants of clinical trials, healthcare personnel etc.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.