The
Sponsor is running an international phase III trial in Crohn’s disease. Study
recruitment is challenged by initial low incidence of the disease, combined
with a big number of competing trials, as well as COVID-19 impact. As an
escalation strategy and to reengage sites that are behind on the enrollment,
the Sponsor decided to perform booster visits, including on-site visits by GCT
team in Russia.
Patient
recruitment and retention strategy is a huge part of proactive contingency
planning of any the trial. Booster visit is an important component
of the planning that allows sites and Sponsors/CROs to get together and develop
an action plan to reach the enrollment projections.
“We are struggling with
patient recruitment in this trial, and under normal circumstances we as a
Sponsor make individual visits to each of our sites to boost patient
recruitment. Still, the horrid COVID-19 pandemic is keeping us from making
individual visits by ourselves, thus forcing us to find alternatives – booster visits
made by local CRO. It is the fact that local CROs are more likely to have
pre-existing strong relationships with PIs or other personnel who can
positively affect patient recruitment. Our aim is to make booster visits to
those sites by GCT (with pre-existing relationships and rapport) and to have
positive effect in patient recruitment that we are having a hard time with.”
GCT is a full-service clinical research organization operating in Russia
since 2001. The company have established strong relationships with PIs and
sites countrywide. GCT has scheduled face-to-face meetings with Investigator site teams in Kazan, Irkutsk, St.
Petersburg, Moscow, Tomsk and Samara. Moreover, the first visit has already
been conducted.
“Nowadays, it has become complicated for Sponsor
to closely oversee the process of clinical trials due to travel restrictions.
Having a reliable and experienced partner who is able to provide a high-level
service and engage the study team is the key to solving this problem” —
said Dr. Eugene Selivra, GCT CEO.