15th International Eurasian Pharmaceutical Forum

Market of clinical research in Russia and the EAEU: barriers and opportunities.

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Over the past year, up to half of the planned studies of innovative medicinal product were suspended in Russia. According to the data for the first half of 2022, the number of approvals for medicinal product studies for pharmaceutical manufacturers from the European Union and the USA decreased by almost 19%, while for Russian manufacturers the number of approvals increased by 90%. According to experts, this growth was mainly due to generics. The number of such medicinal products will grow, but the output of innovative medicinal products will be delayed.

The solution may be to expand cooperation in the Eurasian space. How do analysts and market players themselves see the situation with CS? What trends are setting the industry in motion for 2023? And where to look for new opportunities? Andrey Alasheev, Director of Sciencefiles, PhD, told about it in an exclusive interview with Adam Smith Conferences.
- Andrei Marisovich, we all know about the rather alarming statistics on clinical studies. How critical is the situation and what changes has the Russian market experienced over 2022?

The clinical studies market has changed qualitatively over 2022. The primary cause of the dynamics was the geopolitical factor, which led to a sharp change in the geography of sponsors of approved studies, as well as the suspension or early termination of a number of international clinical studies in the EAEU and CIS.

The clinical studies market in Russia is the largest among all CIS countries. According to the ClinicalTrials.gov register, in 2021 the Russian Federation accounted for 85.4% of all interventional clinical studies in the CIS countries. In 2022, the rate drops to 74.8%. However, this decrease is not critical. Especially since not all clinical studies in the post-Soviet space are submitted to the ClinicalTrials register.

- What do the figures on specific studies say if we compare the indicators for Russia and Eurasian cooperation countries?

In 2021, according to the WHO International Clinical Trials Registry Platform, Russia ranked 22nd by the number of clinical studies, and was 18 times ahead of Belarus on this indicator, which ranked second among CIS countries, but only 70th among all countries in the world.

Thus, it can be stated that changes in the Russian clinical studies market are significantly reflected in the entire EAEU and CIS clinical studies market. The significant discrepancy between the WHO (ICTRP) and US data (ClinicalTrials.gov) and the RF Ministry of Health statistics on the number of clinical studies in Russia is noteworthy, as foreign registries underestimate this number.

According to government statistics, the number of approved clinical studies in Russia decreased by 18.5% over the past year. From 908 in 2021 to 740 in 2022. The declines were not critical and close to those in 2019-2020 (746 and 734 studies). Thus, in itself, the decline in the number of approved studies would not be so debatable were it not for the qualitative dimensions of their design.

- And what do your reports say - how has the market structure changed by country, sponsors and partners in the EAEU?

Sciencefiles tracks clinical study information and shares its observations with everyone in a freely available analytical report format. As a company that helps both pharmaceutical startups and pharma giants conduct clinical studies in the EAEU and CIS, Sciencefiles is constantly studying what regulators approve, especially in Russia. Over the past ten years, the company has developed a unique knowledge base that is used to design clinical trials.

So, the share of approved studies from Russian sponsors increased from 45.7% in 2021 to a record 71.0% in 2022. The share of sponsor research from EAEU (excluding Russia) increased from 1% in the fourth quarter of 2021 to 32% in the fourth quarter of 2022. While over the same period of time the share of studies from sponsors decreased from 61% to 32%, and North American sponsors left the Russian market altogether by the end of the year. For the first time, sponsors from Belarus ranked fourth in the number of clinical studies approved from them in Russia among all foreign studies.

The presence among the EAEU countries of countries under Western sanctions, as well as the absence of such sanctions, creates a unique opportunity for the development of clinical studies in Kazakhstan, Armenia and Kyrgyzstan. I believe that this thesis will be discussed many times during the upcoming Forum.

The change in the sponsor structure and the abandonment of most Western companies' plans to initiate clinical studies in Russia, combined with the fact that most Russian companies are mainly focused on generics production, led to a significant increase in the share of generic clinical studies in 2022, rising significantly from 2014 - 2021 to 69% (508 studies).

For a similar reason, the share of bioequivalence studies increased significantly, reaching a historical high of 58%, with a natural decrease in the share of Phase III trials (down to 25%). Accelerating the procedure for bringing generics to market by optimizing the clinical development stage will also be one of the topics of the focus session at the upcoming Eurasian Pharmaceutical Forum.

- Pharmaceutical companies themselves have not completely abandoned their own clinical studies programs against the background of economic turmoil?

The events of the past year not only created new trends, but also accelerated the trends of previous years. Thus, in 2022, the trend of pharmaceutical companies' autonomy in conducting clinical studies of medicinal product continued. The share of studies in Russia in which sponsors stated their intention to involve a CRO or other organization continued to decline, reaching 29.4% in 2022.

We've been paying attention to this trend for a long time because Sciencefiles has historically helped sponsors conduct clinical studies on their own, providing support for phases that require complex competencies: protocol development, date management, biostatistics, and writing the final report. From conversations with the sponsors, we concluded that the need to organize in-house was related to both savings and easier monitoring of research progress. In recent years we have seen an increase in requests to us for complex study designs with combined phases: I+II, II+III and even I+II+III. There is also a growing demand for adaptive research designs.

- In your opinion, what other trends will set the development of the clinical studies market in Russia and the Eurasian space in 2023?

The study of medicinal product safety and efficacy occurs throughout the life cycle of a medicinal product. Interventional (classical) clinical studies with their rigorous scientific approach, where a medicinal product is tested under well-controlled conditions, may be far removed from actual clinical practice, where medicinal products are prescribed to a deliberately more heterogeneous patient population.

Conversely, real-world clinical practice (RWD/RWE) data and evidence, either from observational (postmarketing) studies or from registries and other electronic medical systems, have insufficient consideration of factors that bias the accuracy of safety and efficacy parameter estimates. The realization that the disadvantages of the former are balanced by the advantages of the latter, and vice versa, gave rise to the development of the concept of hybrid clinical studies. Digitalization of healthcare in EAEU and CIS countries increases interest in RWD/RWE.

Ultimately, any clinical study is not an end in itself for pharmaceutical companies, but a means to generate the evidence needed to build a registration or clinical dossier for a medicinal product.

In the EAEU countries, the procedure for bringing the registration dossier into compliance with the Common Technical Document (CTD) format should be completed by the end of 2025. Since 2015, Sciencefiles has been one of the first companies in the EAEU to help pharmaceutical companies prepare registration dossiers according to the new rules. Sciencefiles' portfolio includes over 800 international nonproprietary names, including "complex medicinal products": microorganisms, radiopharmaceuticals, medical gases, vaccines, rare dosage forms and more.

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