therapeuticЮжно-Российский журнал терапевтической практикиSouth Russian Journal of Therapeutic Practice2712-81563033-8344РостГМУ10.21886/2712-8156-2023-4-3-76-86therapeutic-405Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL RESEARCHНовые подходы к оценке и классификации параметров набора пациентов для проведения II-III фаз клинических исследованийNew approaches to the assessment and classification of patient's selection parameters for phase II-III clinical trialshttps://orcid.org/0000-0001-9843-6096МиловановС. С.MilovanovS. S.

Милованов Святослав Сергеевич – к.м.н., независмый исследователь; ИП Милованов Святослав Сергеевич

Москва

Milovanov Svyatoslav S. – Cand. Sci. (Med.), independent researcher; IP Milovanov Svyatoslav Sergeevich

Moscow

milovanovss@gmail.comИП Милованов Святослав СергеевичРоссияSE Milovanov Svyatoslav SergeevichRussian Federation202323092023437686Copyright © 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.therapeutic-j.ru/jour/article/view/405Цель

Цель: изучить скорость набора пациентов для включения в клиническое исследование по различным параметрам и её изменение под действием внутренних факторов, разработать новые показатели, которые могли бы быть чувствительными для оценки действия обозначенных факторов.

Материалы и методы

Материалы и методы: ретроспективный анализ данных II-III фаз четырёх клинических исследований в области онкологии и гематологии, проведенных с 2007 по 2017 гг.

Результаты

Результаты: изучена скорость набора пациентов, другие параметры набора пациентов и их деривативы, на которые воздействовали внутренние факторы.

Выводы

Выводы: набор пациентов подвержен воздействию внутренних факторов. Данное влияние может быть разнонаправленным: увеличивая набор пациентов или, наоборот, уменьшая его. Зная направленность воздействия определенного фактора, можно спрогнозировать успешность как набора пациентов, так и клинического исследования в целом.

Objective

Objective: to study the rate of enrollment of patients for inclusion in clinical trial according to various parameters and its change under the influence of internal factors, to develop new parameters and indicators that could be sensitive for assessing the effect of the this factors.

Materials and methods

Materials and methods: a retrospective analysis of phase II-III data from four phase II-III clinical trials in the field of oncology and hematology conducted from 2007 to 2017.

Results

Results: the rate of recruitment of patients, other parameters of recruitment of patients and their derivatives, which were influenced by internal factors, were studied.

Conclusions

Conclusions: Patient recruitment is affected by internal factors. This impact can be multidirectional: can increase the number of patients or, conversely, reduce it. Knowing the direction of the influence of a certain factor, it is possible to predict the success of both the recruitment of patients and the success of the clinical trial in general.

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