Speed, Quality, and Cost
Anna Ravdel, SynRG’s director of business development, told GEN that Russia enjoys three strengths as a clinical trials venue: speed, quality, and cost.
Patients flock to trials, she said, in order to gain access to the best physicians and medication as well as due to shortcomings of the state healthcare system ranging from limited government reimbursement for medication to the fact the insurance and governmental medical systems do not cover all patients and diseases.
The quality of clinical data is high enough to withstand FDA and EMA inspections, with both agencies approving drugs using data collected from Russian sites—13 EMA approvals and an FDA approval during Q2 alone. While Russian drug companies accounted for a plurality of approved clinical trials during the second quarter (115), five global biopharma giants—Roche, Pfizer, AstraZeneca, GlaxoSmithKline, and Teva —were approved for a combined 31 studies totaling 3,916 patients, according to SynRG.
“We recommend to our clients to include Russia early into their clinical trial program if they have plans in the future to register the drug in Russia, because otherwise, without any patients from Russia, the registrators in the Ministry of Health may require the sponsor to conduct another study in Russia, even though the entire program has been completed,” Leon Dzivinsky, senior vp and general counsel for ClinStar, a provider of clinical development services in Russia and Eastern Europe, told GEN.
Dzivinsky, whose company is involved at any point in 40 to 50 clinical studies, said Russian clinical trials enjoy faster patient recruitment timeframes—in one instance, saving 17 months or $15 million for one Phase III trial of an advanced breast cancer drug. ClinStar needed just 24 months to recruit 318 patients in Russia, Estonia, Ukraine, and Belarus, vs. 41 months for 542 patients in 18 other nations (none being the U.S).
Patients recruited for clinical studies in Russia don’t turn over as often as elsewhere: “Whatever the doctor tells the patient, they tend to follow. They treat the doctor as a top authority. And if they start with a particular doctor in an indication, they tend to stick with that doctor throughout the term of their treatment,” Dzivinsky said.