farmaecFARMAKOEKONOMIKA. Modern Pharmacoeconomics and PharmacoepidemiologyФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология2070-49092070-4933IRBIS LLC10.17749/2070-4909/farmakoekonomika.2024.257farmaec-1084Research ArticleREVIEW ARTICLESОБЗОРНЫЕ ПУБЛИКАЦИИTrends in the industry of clinical trialsТенденции развития индустрии клинических исследованийhttps://orcid.org/0000-0001-9843-6096МиловановС. С.MilovanovS. S.

Милованов Святослав Сергеевич, к.м.н.

Scopus Author ID: 58575569000

Ленинский пр-т, д. 73/8, Москва 119296

Svyatoslav S. Milovanov, PhD

Scopus Author ID: 58575569000

73/8 Leninsky Ave., Moscow 119296

milovanovss@gmail.comhttps://orcid.org/0000-0002-1570-2748ПоповВ. В.PopovV. V.

Попов Владимир Васильевич, д.м.н., проф. 

WoS ResearcherID: G-9168-2018

Scopus Author ID: 57195756066

Волоколамское ш., д. 11, Москва 125310; 

ул. Советская/Коммунальная, д. 93/2, Тамбов 392000

Vladimir V. Popov, Dr. Sci. Med., Prof.

WoS ResearcherID: G-9168-2018

Scopus Author ID: 57195756066

11 Volokolamskoe Shosse, Moscow 125310; 

93/2 Sovetskaya/Kommunalnaya Str., Tambov 392000

ТепловаН. В.TeplovaN. V.

Теплова Наталья Вадимовна, д.м.н., проф. 

Scopus Author ID: 55199144000

ул. Островитянова, д. 1, Москва 117997

Natalia V. Teplova, Dr. Sci. Med., Prof.

Scopus Author ID: 55199144000

1 Ostrovityanov Str., Moscow 117997

Независимый исследовательРоссияIndependent ResearcherRussian FederationФедеральное государственное бюджетное образовательное учреждение высшего образования «Российский биотехнологический университет (РОСБИОТЕХ)»; Федеральное государственное бюджетное образовательное учреждение высшего образования «Тамбовский государственный университет им. Г.Р. Державина»РоссияRussian Biotechnological University (ROSBIOTECH); Derzhavin Tambov State UniversityRussian FederationФедеральное государственное автономное образовательное учреждение высшего образования «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Министерства здравоохранения Российской ФедерацииРоссияPirogov Russian National Research Medical UniversityRussian Federation202502052025181104113Copyright © Milovanov S.S., Popov V.V., Teplova N.V., 20252025Милованов С.С., Попов В.В., Теплова Н.В.Milovanov S.S., Popov V.V., Teplova N.V.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmacoeconomics.ru/jour/article/view/1084Background

Background. The clinical trial (CT) industry is subject to changes, some of which are rapidly developing and their directions can be predicted, while others develop gradually, forming stable tendencies, which requires analysis to confirm and predict them. According to the generally accepted time gradation, there are an operational (up to 1 month), short-term (up to 1 year), medium-term (up to 5 years), long-term (up to 20 years), and long-term (over 20 years) prognoses. A short-term forecast is common in CT industry.

Objective

Objective: to identify trends in the development of CT industry until the end of 2024.

Material and methods

Material and methods. We searched publications in Russian and English segments of the Internet in open access sources in ClinicalTrials.gov, PubMed/MEDLINE, Google Scholar, Academia, ResearchGate, CyberLeninka, eLibrary databases by key query “trends in clinical trials” for the period from January to March 2023. The query “history of clinical trials” was also used in Russian part of the Internet through Google search. The analysis included publications on the history of CT development over 1936–2023. The total number of sources analyzed was 59 (9 Russian and 50 English).

Results

Results. The tendencies in CT development can be divided into two groups. The first one is related to CT organization and conducting, while another is associated with development of innovative drugs. In the first group, the trends have persisted since 2022 and are expressed in the ongoing digitalization of operational activities, a shift from centralized research to decentralization, while the protocol design has changed towards patient-centricity. In the second group, the number of expected drugs has decreased and a shift towards biological drugs, gene and cell therapy has become more pronounced.

Conclusion

Conclusion. Trends in CI are characterized by a number of innovations, primarily related to digitalization, the development of telemedicine technologies, mathematical modeling, artificial intelligence, virtual CI, decentralization and patient-centricity.

Актуальность

Актуальность. Индустрия клинических исследований (КИ) подвержена изменениям, одни из которых развиваются на коротком промежутке времени и их направление можно спрогнозировать, в то время как другие изменения развиваются постепенно и длительно, формируя устойчивые тенденции, анализ которых необходим, в частности, и для их подтверждения и прогнозирования. Согласно общепринятой временной градации выделяют оперативный (до 1 мес), краткосрочный (до 1 года), среднесрочный (до 5 лет), долгосрочный (до 20 лет) и дальнесрочный (свыше 20 лет) прогноз. В индустрии КИ распространен краткосрочный прогноз.

Цель

Цель: выявить тенденции развития индустрии КИ до конца 2024 г.

Материал и методы

Материал и методы. Проведен поиск публикаций в русскоязычном и англоязычном сегментах сети Интернет в источниках с открытым доступом в базах данных ClinicalTrials.gov, PubMed/MEDLINE, Google Scholar, Academia, ResearchGate, КиберЛенинка, eLibrary по ключевым запросам “trends in clinical trials” и «тенденции в клинических исследованиях» за период январь с января по март 2023 г. Также использовали запрос «история клинических исследований» в русскоязычной части интернета через поиск Google. В анализ попали публикации по истории развития КИ за период 1936–2023 гг. Общее количество проанализированных источников составило 59, из них 9 русскоязычных и 50 англоязычных.

Результаты

Результаты. Тенденции развития КИ можно разделить на две группы – связанные с организацией и проведением КИ и с трендами в разработке инновационных лекарственных препаратов. В первой группе тенденции остались сходными с 2022 г. – продолжающаяся дигитализация операционной деятельности, смещение централизованных исследований в сторону децентрализации, a дизайна протокола – в сторону пациентоцентричности. Во второй группе количество ожидаемых препаратов уменьшилось и наблюдается смещение в сторону биологических препаратов, препаратов генной и клеточной терапии.

Заключение

Заключение. Тенденции в КИ характеризуются целым рядом новаций, связанных в первую очередь с цифровизацией, развитием телемедицинских технологий, математического моделирования, искусственного интеллекта, виртуальных КИ, децентрализацией и пациентоцентричностью.

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The authors declare that there are no conflicts of interest present.