The Immediate Question: How to Stop?
That very first day, it appeared that clinical research in Ukraine had fully collapsed. All local operations immediately stopped all activity. All international couriers immediately stopped. No airplane connections, no ground transportation, no public transportation. All borders blocked by millions of people evacuating from Ukraine. Pharmacies closed. We decided to be with our patients and to provide their medical services by staying at our main clinic in Kiev, although we were down to about 12 site staff. But all sponsors stopped enrollment, and some even stopped already randomized patients, immediately. On the second day of the war, patients started to call us: Are you continuing? Will you be with us? We have no access to other hospitals. We have no pharmacy. We have nothing. After discussion with sponsors, we decided to continue to treat these patients. Twelve medics, here for 24 hours. We slept in our basement safely, on the ground. During the day, we climbed up to our third floor and continued with patient visits
To enable trials to continue, it was critical that local labs resumed operations. Patients were offered options for continued participation in their trials in Ukraine: Visit their clinic, home visits, a combination of home and office visits, or telephone visits only. Procedures for interacting with ethics committees were revised to allow for remote interactions. To support these approaches practically, the following should be considered in the design of trials and research studies in a time of disruption:
- Options for telemedicine, electronic signatures for informed consent, remote monitoring, and related adaptations
- Build flexibility into local ethics committee standard operating procedures
- Timely communications with and flexibility from regulatory bodies
- Build flexibility into protocols to allow for changes in approach and delivery
- Build in flexibility to shift patients from one study site to another to reduce risk and enable continuity.
For many participants, no access to research meant no access to their study medication or routine care. Approvals from patients, sponsors, and regulatory authorities allowed patients to move to study sites in neighboring countries conducting the same study. To facilitate the transfer, the following was required:
- Shifting of site- or study-specific equipment and accommodations and additional investigational medicinal product (IMP) to the receiving site
- Adjustment of the Interactive Voice Response System (IVRS) to reflect the details (and the language, if necessary) of the new site
- Reliance upon verbal approval for transfers since some patients were in urgent situations and needed their medications immediately
- Submission of all documentation to regulatory authorities in both Ukraine and the receiving country following transfer
The receiving country must also make some regulatory adjustments before accepting these patients. Additionally, sites in Ukraine must now also consider how to accommodate patient cross-border travel because patients travel back and forth between countries.