clinvestКачественная клиническая практикаKachestvennaya Klinicheskaya Praktika = Good Clinical Practice2588-05192618-8473ООО «Издательство ОКИ10.37489/2588-0519-2022-4-13-23clinvest-635Research ArticleКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯCLINICAL TRIALSФакторы, влияющие на набор пациентов в международных мультицентровых клинических исследованиях II–III фазFactors, influencing to the recruitment of international multicenter clinical trials of II–III phaseshttps://orcid.org/0000-0001-9843-6096МиловановС. С.MilovanovS. S.

Милованов Святослав Сергеевич, к. м. н., независимый исследователь

Москва

Milovanov Svyatoslav S., Cand. Sci. (Med.), independent researcher

Moscow

milovanovss@gmail.comИиндивидуальный предприниматель Милованов Святослав СергеевичРоссияSole entrepreneur Milovanov Svyatoslav SergeevichRussian Federation202201032023041323Copyright © Милованов С.С., 20232023Милованов С.С.Milovanov S.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.clinvest.ru/jour/article/view/635

Набор пациентов в клиническое исследование — это процесс со многими ограничениями. В первую очередь ограниченный во времени, и удлинение процесса набора пациентов во времени увеличивает риск неудачи всего исследования. Помимо фактора времени, на набор пациентов влияют множество других факторов. Влияние факторов разнонаправленно, и один фактор может влиять как положительно на набор пациентов, так и отрицательно. Мы рассмотрели часть факторов в рамках предложенной нами классификации. Материалы и методы. Проведён ретроспективный анализ 4 международных мультицентровых клинических исследований (ММКИ) II–III фаз по набору пациентов в зависимости от влияния факторов. Цель исследования. Рассмотреть влияние различных факторов на набор пациентов с точки зрения изменения набора пациентов и некоторых других параметров и показателей. Статистический анализ. Описательная статистика с типированием. Результаты. Факторы классифицированы на две группы, и рассмотрено их влияние на набор пациентов. Обсуждение. По данным литературы, авторы разработали большое количество классификаций групп, и мы предложили свою классификацию.

Recruiting patients to a clinical trial is a process with many limitations. First of all, the time-limited and lengthening of the patient recruitment process in time increases the risk of failure of the entire study. In addition to the time factor, many other factors affect the recruitment of patients. The influence of factors is multidirectional and one factor can affect both positively and negatively the recruitment of patients. We have considered some of the factors within the framework of our proposed classification. Materials and methods. A retrospective analysis of 4 international multicenter clinical trials (MSCI) of phases II–III on the recruitment of patients, depending on the influence of factors, was carried out. The purpose of the study. To consider the influence of various factors on the set of patients by changing the set of patients and some other parameters and indicators. Statistical analysis. Descriptive statistics with typing. Results. The factors are classified into two groups and their influence on the recruitment of patients is considered. Discussion. According to the literature, the authors have developed a large number of classifications of groups, and we have proposed our own classification.

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