FutureMeds Ukraine achieved an important milestone in October by exceeding their target for an ongoing clinical trial for Systemic Mastocytosis. Previously, difficulties in finding eligible patients had slowed the Sponsor’s progress in Ukraine.
Against all odds, our Ukrainian dedicated research site team at Oberig Clinic in Kyiv exceeded expectations in patient recruitment for an ongoing Systemic Mastocytosis trial.
Initially, the protocol goal was to include 4-5 patients within a year. Astonishingly, Oberig screened 5 and randomized 3 patients in just 6 weeks. And they are not stopping there.
Patients have been lacking proper care for Systemic Mastocytosis despite the medical community’s decades-long push to find an effective solution for it. This trial aims to confirm the effectiveness of a new treatment that might get patients closer to a solution.
Systemic Mastocytosis is an aggressive rare disorder with severe symptoms and a high risk of near-death allergic reactions. It results in a wide variety of symptoms that can make its correct diagnosis challenging. The symptoms can include itching, rash, depression, digestive system disorders, a constant risk of unpredictable anaphylactic shock, sometimes leading to death, and neuropsychiatric complaints.
Recruitment challenges and a FutureMeds Ukraine solution
Recruiting patients for this trial is challenging due to the relative rarity of the disorder. The reported prevalence in Europe is 1 per 10,000 individuals, with high levels of under- and misdiagnosis. For inclusion in this trial, invasive bone marrow biopsies are also needed to confirm the diagnosis.
Due to the likelihood of under- and misdiagnosis, understanding the true prevalence of a disorder like this in a country can be challenging for any Sponsor. Well-established teams on the ground can play an essential role in helping Sponsors and CROs better understand the local realities.
“We played an important role in restructuring the approach to the study in Ukraine and adjusting the budget accordingly, which enhanced patient recruitment capabilities.”
- Ivan Vyshnyvetskyy, Managing Director at FutureMeds Ukraine
Previously, only 3 patients from 4 sites were enrolled in Ukraine during 2020-2021. When FutureMeds Ukraine joined the trial in September, the protocol recruitment timeline for enrolling 4-5 volunteers was 12 months.
It took 3 months from feasibility to the Site Initiation Visit, and a day after IMP was delivered to the site, our Oberig team screened the first patient. Within about 60 days, they screened 5 patients in total and enrolled 3 into the study.
To put this performance into context, the global enrollment speed is approximately 0.04 rands per month per site. Since Oberig’s initiation, the team has delivered 1,5 rands/month, with a waiting list of patients still in place.
Whilst preparing for the SIV, our team worked closely with key opinion leaders in the field and identified an approach that can significantly simplify patient identification and recruitment. While the disease is quite uncommon, by making confirmation of the diagnosis a part of screening procedures, Oberig could make strides in finding eligible patients for the study.
“We have a strong reputation in the local market, and this reputation allows us to build productive relationships with key opinion leaders in the field. And these relationships continue to help us gain access to the right patient population.”
- Ivan Vyshnyvetskyy, Managing Director at FutureMeds Ukraine
On the trial journey, the Oberig team is now accompanied by the well-established and renowned team of MC Pulse. They recently joined FutureMeds.
About FutureMeds
FutureMeds is the 1st European Independent Dedicated DCT Site Network, offering high traditional trial and DCT readiness across the whole network and home nursing solutions in 18 countries.
FutureMeds’ Dedicated Research Site teams strive to accelerate study timelines, streamline processes, lower costs and improve data quality to help speed up drug development and patient access to new treatments.
Through acquisitions and a strategic focus on patient experience, FutureMeds has developed large, qualified patient pools across Europe that enable faster patient enrolment, stronger retention and more accurate results.
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