clinvestКачественная клиническая практикаKachestvennaya Klinicheskaya Praktika = Good Clinical Practice2588-05192618-8473ООО «Издательство ОКИclinvest-13Research ArticleКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯCLINICAL TRIALSВалидация электронных систем сбора данных «Оценок Результатов Пациентами» - Рекомендации для клинических исследователей: отчёт Целевой Группы ISPOR по надлежащей исследовательской практике валидации ePRO системValidation of Electronic Systems to Collect Patient-Reported Outcome (PRO) Data - Recommendations for Clinical Trial Teams: Report of the ISPOR ePRO Systems Validation Good Research Practices Task ForceZbrozekArthurZbrozekArthurnoemail@neicon.ruHebertJoyHebertJoynoemail@neicon.ruGogatesGregoryGogatesGregorynoemail@neicon.ruThorellRodThorellRodnoemail@neicon.ruDellChristopherDellChristophernoemail@neicon.ruMolsenElizabethMolsenElizabethnoemail@neicon.ruCraigGretchenCraigGretchennoemail@neicon.ruGriceKennethGriceKennethnoemail@neicon.ruKernScottieKernScottienoemail@neicon.ruHinesSheldonHinesSheldonnoemail@neicon.ruПавлышА. В.PavlyshA. V.noemail@neicon.ruТопоровА. А.ToporovA. A.noemail@neicon.ruВербицкаяЕ. В.VerbitskayaE. V.noemail@neicon.ruКолбинА. С.KolbinA. S.noemail@neicon.ruGlobal Health Economics, CSL Behring, Biotherapies for Life, King of Prussia, PAСоединённые Штаты АмерикиGlobal Health Economics, CSL Behring, Biotherapies for Life, King of PrussiaUnited StatesPHT Corp, Boston, MAСоединённые Штаты АмерикиPHT CorpUnited StatesCRF Health, Plymouth Meeting, PAСоединённые Штаты АмерикиCRF Health, Plymouth MeetingUnited StatesPHT Corp, Charlestown, MAСоединённые Штаты АмерикиPHT CorpUnited StatesERT, Philadelphia, PAСоединённые Штаты АмерикиERT, IncUnited StatesInternational Society for Pharmacoeconomics & Outcomes Research (ISPOR)Соединённые Штаты АмерикиInternational Society for Pharmacoeconomics & Outcomes ResearchUnited StatesERT, Inc., Pittsburgh, PAСоединённые Штаты АмерикиERT, IncUnited StatesGlobal Electronic Data Capture, Bayer HealthCare Pharmaceuticals, Inc., Montville, NJСоединённые Штаты АмерикиGlobal Electronic Data Capture, Bayer HealthCare Pharmaceuticals, IncUnited StatesSacaja Consulting Ltd., WiltshireВеликобританияSacaja Consulting LtdUnited KingdomICON Late Phase & Outcomes Research, Durham, NCСоединённые Штаты АмерикиICON Late Phase & Outcomes ResearchUnited StatesПервый Санкт-Петербургский государственный медицинский университет имени академика И.П. ПавловаРоссияFirst Pavlov State Medical University of Saint Petersburg, Saint Petersburg, RussiaRussian FederationПервый Санкт-Петербургский государственный медицинский университет им. акад. И.П. ПавловаРоссияFirst Pavlov State Medical University of Saint Petersburg, Saint Petersburg, RussiaRussian FederationПервый Санкт-Петербургский государственный медицинcкий университет имени акад. И.П.Павлова; Санкт-Петербургский государственный университетРоссияFirst Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia; Saint Petersburg State University, Saint Petersburg, RussiaRussian Federation20151605201802318Copyright © Zbrozek A., Hebert J., Gogates G., Thorell R., Dell C., Molsen E., Craig G., Grice K., Kern S., Hines S., Павлыш А.В., Топоров А.А., Вербицкая Е.В., Колбин А.С., 20182018Zbrozek A., Hebert J., Gogates G., Thorell R., Dell C., Molsen E., Craig G., Grice K., Kern S., Hines S., Павлыш А.В., Топоров А.А., Вербицкая Е.В., Колбин А.С.Zbrozek A., Hebert J., Gogates G., Thorell R., Dell C., Molsen E., Craig G., Grice K., Kern S., Hines S., Pavlysh A.V., Toporov A.A., Verbitskaya E.V., Kolbin A.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/13

Литература об исследовании исходов лечения изобилует примерами высококачественных, надёжных данных оценок результатов пациентами (Patient-Reported Outcomes, PRO), введённых исключительно электронными методами, ePRO, которые сравниваются с данными, вводившимися с «бумажных носителей». Менеджеры клинических исследований всё чаще используют сбор данных с помощью ePRO для получения результатов, основанных на PRO. Проверка регуляторных документов позволяет определить правила, которым необходимо следовать, чтобы собирать данные с помощью ePRO в соответствии с требованиями ведения медицинской документации. Критический компонент соблюдения нормативных требований - это свидетельство о валидации (evidence of the validation) системы сбора электронных данных. Валидация (validation) электронных систем - это процесс в отличие от сконцентрированной деятельности (focused activity), которая совершается в определённый момент времени. Валидация программного продукта для сбора данных предусматривает описание и выполнение в условиях его целевой среды следующих восьми шагов: описание требований к системе (requirements definition), дизайн (design), кодирование (coding), тестирование (testing), прослеживание процесса (tracing), тестирование на приемлемость для пользователя (user acceptance testing), установка (installation) и конфигурирование системы (configuration), а также списание (decommissioning). Указанные элементы согласуются с последними руководствами регуляторных органов по валидации систем. Этот отчёт был написан, чтобы объяснить, каким образом процесс валидации работает для спонсоров, клинических исследователей и прочих пользователей устройств по сбору электронных данных, ответственных за проверку качества данных, вводимых в реляционные базы данных посредством подобных устройств. Это руководство устанавливает 2 документальных требований, необходимые системному провайдеру системы сбора данных для демонстрации валидности системы. Это практический источник информации для исследовательских групп, позволяющий убедиться, что поставщики ePRO используют те способы валидации системы и реализации процессов, которые гарантируют, что системы и сервисы работают надёжно на практике, производят точные, полные и целостные данные (файлы данных), поддерживают административное управление и соответствуют текущим регуляторным требованиям. Более того, этот короткий отчёт улучшит понимание требований пользователя к технической валидации, что ведёт к более информированным и сбалансированным рекомендациям или решениям по вопросам методов сбора электронных данных.

Validation of Electronic Systems to Collect Patient-Reported Outcome (PRO) Data - Recommendations for Clinical Trial Teams: Report of the ISPOR ePRO Systems Validation Good Research Practices Task Force Abstract. Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based endpoints. Regulatory review dictates the rules to follow with ePRO data collection for medical label claims. A critical component for regulatory compliance is evidence of the validation of these electronic data collection systems. Validation of electronic systems is a process versus a focused activity that finishes at a single point in time. Eight steps need to be described and undertaken to qualify the validation of the data collection software in its target environment: requirements definition, design, coding, testing, tracing, user acceptance testing, installation and configuration, and decommissioning. These elements are consistent with recent regulatory guidance for systems validation. This report was written to explain how the validation process works for sponsors, trial teams, and other users of electronic data collection devices responsible for verifying the quality of the data entered into relational databases from such devices. It is a guide on the requirements and documentation needed from a data collection systems provider to demonstrate systems validation. It is a practical source of information for study teams to ensure that ePRO providers are using system validation and implementation processes that will ensure the systems and services: operate reliably when in practical use; produce accurate and complete data and data files; support management control and comply with any existing regulations. Furthermore, this short report will increase user understanding of the requirements for a technology review leading to more informed and balanced recommendations or decisions on electronic data collection methods.

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