Allucent, as a global CRO, has over 20 years’ experience conducting clinical trials in Central and Eastern Europe (CEE). In this article we will review the key benefits of conducting research in Russia and why you should consider the country and Russian investigative sites for inclusion in your next clinical trial.
As you know, the decision to launch studies in particular countries is not an arbitrary one. The countries and investigative sites you select will have significant influence on access to desired patient populations, speed of recruitment, and study completion timelines. In our years of experience working in Russia, this country has repeatedly proven that we can obtain exceptional clinical data and has been a high enroller on many of our studies. This is due to many factors which we will discuss, but certainly one of them is the experienced team we have in Russia and the relationships they have built. Conducting clinical research in Russia has many benefits which we will explore further below.
Key Benefits to Conducting Clinical Trials in Russia
Russia has many advantages that can benefit clinical research conduct. Here are our top takeaways summarized:
- 9th Largest Country by Population: 146 million
- Densely Populated Major City Centers:
- Moscow (federal city): 12.43 million
- Saint Petersburg (federal city): 5.38 million
- Novosibirsk Oblast (Siberia): 1.61 million
(Pharm-Olam, via our MB Quest wholly-owned subsidiary, maintains an office in the three largest cities in Russia identified above.)
- Beneficial Patient Funnel: Centralized medicine, public network as well as competitive private clinics
- Accredited Sites for Research: Not all sites in Russia can conduct research. Presently there are ~1,500 RA accredited sites capable of conducting clinical research.
- SoC Treatment Environment: Not all standard of care (SoC) medications are reimbursed by the government and some of them are very expensive. Clinical trials can be advantageous for patients in need.
- Consistent and Reliable Regulatory Framework: Sites activated within 4-5 months
- Favorable Costs for Research: As of today, research in Russia is financially advantageous when compared to North America and Europe.
- A Proven High Enroller: Russia has repeatedly been a high enroller for various indications panning rare disease to allergy and autoimmune.
Established Patient Funnels
Healthcare institutions are both governmental and private, but all types of clinics have to receive license for medical care. Clinics can be Federal (country-level), Regional (covering particular region), or Municipal (covering a particular city). In terms of clinical trials and our experience in Russia, the Municipal/local sites are not always set-up optimally for complicated indications, but they are very good in recruitment. At the same time, Regional and Federal hospitals are very important in particular for rare diseases or complicated study designs because they offer access to a larger patient population and can support complex / complicated indications.
Depending on the disease and its complexity, patients can be treated at Municipal (local) hospitals, but they can be also directed to Regional and Federal hospitals where they will have more opportunities for high-tech medical care, innovative treatments, and diagnostic procedures. In case of rare diseases, big federal hospitals have access to a country-level data base of patients which supports the recruitment.
Competitive Private Clinics
This situation introduces certain advantages. In practice, we see that private clinics in Russia are trying to compete with the larger federal centers to become research study sites. They provide good quality investigators as well as faster timelines. In particular, we have seen the largest improvement in contract negotiation timelines, local EC approval, and site team collaboration.
Research Accredited Sites
In order to participate in research, the hospital or clinic needs to submit to RA accreditation. Today, there are 1500 sites with RA accreditation in Russia. Early on, most of the approved facilities were large regional hospitals or universities, but that has evolved. Many state and private medical facilities are trying to compete for studies.
Access to SoC Treatments
A combination of high medical costs and low reimbursement rate can make clinical studies a potentially attractive option for patients. Not all standard of care (SoC) medications are reimbursed by the government and some of them are very expensive. In addition, the list of SoC reimbursed medications may vary from one region to another. Patients in some regions or cities may not have access to innovative options or the best treatment standards due to lack of reimbursement in a particular region and high costs for purchasing.
Favorable Cost Structures
Russia also has a favorable cost structure. Compared to research sites in the European Union or the United States, the costs for investigator grants, diagnostics procedures, and regulatory fees are significantly lower. The regulatory fee is applicable only for the initial study submission and all further submissions are free of charge, including import/export license and protocol amendments. Local ECs are mainly free of charge, but those who are paid have quite low fees comparing to EU EC costs.
Russia – A Proven High Enroller
Through our team in Russia (with offices located in the three largest Russian cities), we are able to cover the majority of the country’s regions, which spans thousands of kilometers from each other and crosses multiple different time zones. Allucent’s CRAs are highly familiar with the main research sites in Russia, the key opinion leaders of their region and this positively influences our ability to deliver study timelines, recruitment and oversight in general.
Russia has been a repeat high enroller on many of our trials. Recently our Russian Investigators and CRAs have provided some of the highest patient enrollment figures on the following indications:
- Acromegaly
- Pulmonary Arterial Hypertension
- Ventilator-Associated Pneumonia
- Multiple Allergy studies
- Ulcerative Colitis
Conclusion
As we know, study site and country selection are a serious matter. Choose a CRO that will help you understand your options and select the location that will work best for your study’s needs. Allucent’s approach to country and site selection, through our Discover 360 tool, can help you optimize your site and country selection. Our team in Russia has the depth of experience and investigator relationships necessary to make your study a success. To learn more about how Allucent can help your clinical research efforts in Russia, speak with our team today.
Authors:
Yury Mescherskiy, Regional Director, Global Clinical Operations
Marina Trofimova, Clinical Research Manager
John Colby, Exec. Director, Global Marketing & Communications
Renee Breiten, Marketing Content Manager