myrwdРеальная клиническая практика: данные и доказательстваReal-World Data & Evidence2782-3784Publishing House OKI10.37489/2782-3784-myrwd-19GBRMFZmyrwd-23Research ArticleМЕТОДОЛОГИЯMETHODOLOGYSTaRT-RWE: структурированный шаблон для планирования и отчëтности о проведении исследований в условиях реальной клинической практикиSTaRT-RWE: structured template for planning and reporting on the implementation of real-world evidence studieshttps://orcid.org/0000-0001-9159-6177ПлавинскийС. Л.PlavinskijS. L.

Плавинский Святослав Леонидович — д. м. н., профессор  кафедры  педагогики,  философии и права

Санкт-Петербург

Plavinskij Sviatoslav L. — MD, PhD, DSc, profes- sor of the Department of Teaching, Philosophy and Law

Saint Petersburg

s.plavinskij@szgmu.ruhttps://orcid.org/0000-0002-8180-9340БариноваА. Н.BarinovaA. N.

Баринова Анна Николаевна — д. м. н., профессор кафедры общественного здоровья и управления здравоохранением

Санкт-Петербург

Barinova Anna N. — MD, PhD, DSc, professor of the Department of public health and health admin- istration

Saint Petersburg

anna_n_barinova@mail.ruФГБОУ ВО «Северо-Западный государственный медицинский университет им. И. И. Мечникова» Минздрава РоссииРоссияNorth-Western State Medical University named after I. I. MechnikovRussian Federation202217112022232034Copyright © Плавинский С.Л., Баринова А.Н., 20222022Плавинский С.Л., Баринова А.Н.Plavinskij S.L., Barinova A.N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.myrwd.ru/jour/article/view/23Цель исследования

Цель исследования. Выделить особенности STaRT-RWE (структурированного шаблона для планирования и отчётности о проведении исследований в условиях реальной клинической практики — RWE).

Материалы и методы

Материалы и методы. Проведён обзор и анализ публикаций, касающихся особенностей получения доказательств в условиях реальной клинической практики, упрощения сбора доказательных данных, особенно при параллельном рассмотрении нескольких исследований RWE.

Результаты

Результаты. Благодаря использованию данного шаблона происходит отбор критически важных деталей. Важно и то, что при этом разная интерпретация не влияет на результаты и на решение.

Выводы

Выводы. STaRT-RWE предназначен для уменьшения неправильного толкования и создания чётких ожиданий в отношении того, как генерируется RWE касаемо того, какой дизайн исследования и детали должны сообщаться, как и где эти данные должны проявляться, что, в свою очередь, позволит лицам, принимающим решения в области здравоохранения, эффективно оценивать достоверность исследований RWE.

Aim

Aim. To highlight the features of STaRT-RWE (a structured template for planning and reporting on research in real clinical practice — RWE).

Materials and methods

Materials and methods. One has selected and analyzed of the articles, dealing with the special features of getting evidence under conditions of real clinical routine, simplification of proving data collecting, in particular, at simultaneous consideration of several researches RWE.

Results

Results. Due to the use of this pattern, one selects crucially important details. It is also important that the different interpretation does not influence the results and solvation.

Conclusion

Conclusion. STaRT-RWE is meant for decreasing the incorrect interpretation and making clear expectations as for generating RWE if to speak about the research design and its details, how and where these data should be revealed which will allow the persons, taking part in healthcare, estimate the RWE research reliability in an effective way.

реальная клиническая практиказдравоохранениеэффективность терапиишаблон STaRT-RWERWEhealthcareeffectiveness of therapySTaRT-RWE templateReferencesКолбин А. С. и соавт. Исследования реальной клинической практики. — М. : Издательство ОКИ : Буки Веди, 2020.— 208 с. : ил. — ISBN 978-5-4465-2902-5. — https://izdat-oki.ru/issledovaniya-realnoj-klinicheskoj-praktiki.Колбин А. С. и соавт. Исследования реальной клинической практики. — М. : Издательство ОКИ : Буки Веди, 2020.— 208 с. : ил. — ISBN 978-5-4465-2902-5. — https://izdat-oki.ru/issledovaniya-realnoj-klinicheskoj-praktiki.Sun X, Tan J, Tang L, Guo JJ, Li X. Real world evidence: experience and lessons from China. BMJ 2018;360:j5262. doi: 10.1136/bmj.j5262Sun X, Tan J, Tang L, Guo JJ, Li X. Real world evidence: experience and lessons from China. BMJ 2018;360:j5262. doi: 10.1136/bmj.j5262Charter R, Yeung A, Smith M, et al. The assessment of value for medical devices: using real world evidence (RWE) to quantify unmet needs in diabetes management. Value Health 2016;19:A703. doi: 10.1016/j.jval.2016.09.2046Charter R, Yeung A, Smith M, et al. The assessment of value for medical devices: using real world evidence (RWE) to quantify unmet needs in diabetes management. Value Health 2016;19:A703. doi: 10.1016/j.jval.2016.09.2046Li G, Sajobi TT, Menon BK, et al. 2016 Symposium on Registry-Based Randomized Controlled Trials in Calgary Registry-based randomized controlled trials—what are the advantages, challenges, and areas for future research? J Clin Epidemiol 2016;80:16–24. doi: 10.1016/j.jclinepi.2016.08.003Li G, Sajobi TT, Menon BK, et al. 2016 Symposium on Registry-Based Randomized Controlled Trials in Calgary Registry-based randomized controlled trials—what are the advantages, challenges, and areas for future research? J Clin Epidemiol 2016;80:16–24. doi: 10.1016/j.jclinepi.2016.08.003US Food and Drug Administration. FDA’s Sentinel Initiative. 2016.US Food and Drug Administration. FDA’s Sentinel Initiative. 2016.Garrison LP, Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health 2007;10:326–35. doi: 10.1111/j.1524-4733.2007.00186.xGarrison LP, Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health 2007;10:326–35. doi: 10.1111/j.1524-4733.2007.00186.xKo CY, Hall BL, Hart AJ, Cohen ME, Hoyt DB. The American College of Surgeons National Surgical Quality Improvement Program: achieving better and safer surgery. Jt Comm J Qual Patient Saf 2015;41:199–204. doi: 10.1016/S1553-7250(15)41026-8Ko CY, Hall BL, Hart AJ, Cohen ME, Hoyt DB. The American College of Surgeons National Surgical Quality Improvement Program: achieving better and safer surgery. Jt Comm J Qual Patient Saf 2015;41:199–204. doi: 10.1016/S1553-7250(15)41026-8US Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and food and drug administration staff. 31 August, 2017.US Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and food and drug administration staff. 31 August, 2017.Makady A, Ham RT, de Boer A, Hillege H, Klungel O, Goettsch W, GetReal Workpackage 1 Policies for use of real-world data in health technology assessment (HTA): a comparative study of six HTA agencies. Value Health 2017;20:520–32. doi: 10.1016/j.jval.2016.12.003Makady A, Ham RT, de Boer A, Hillege H, Klungel O, Goettsch W, GetReal Workpackage 1 Policies for use of real-world data in health technology assessment (HTA): a comparative study of six HTA agencies. Value Health 2017;20:520–32. doi: 10.1016/j.jval.2016.12.003Oyinlola JO, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv Res 2016;16:299. doi: 10.1186/s12913-016-1562-8Oyinlola JO, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv Res 2016;16:299. doi: 10.1186/s12913-016-1562-8Решение Совета Евразийской экономической комиссии от 17 марта 2022 г. № 36 «О внесении изменений в Правила регистрации и экспертизы лекарственных средств для медицинского применения».Reshenie Soveta Evrazijskoj ekonomicheskoj komissii ot 17 marta 2022 g. N 36 “O vnesenii izmenenij v Pravila registracii i ekspertizy lekarstvennyh sredstv dlya medicinskogo primeneniya” (In Russ.).Wang SV, Verpillat P, Rassen JA, Patrick A, Garry EM, Bartels DB. Transparency and reproducibility of observational cohort studies using large healthcare databases. Clin Pharmacol Ther 2016;99:325–32. doi: 10.1002/cpt.329Wang SV, Verpillat P, Rassen JA, Patrick A, Garry EM, Bartels DB. Transparency and reproducibility of observational cohort studies using large healthcare databases. Clin Pharmacol Ther 2016;99:325–32. doi: 10.1002/cpt.329Wang SV, Pinheiro S, Hua W, et al. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies. BMJ. Jan 12 2021;372:m4856. doi: 10.1136/bmj.m4856 464Wang SV, Pinheiro S, Hua W, et al. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies. BMJ. Jan 12 2021;372:m4856. doi: 10.1136/bmj.m4856 464International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH reflection paper: strategic approach to international harmonization of technical scientific requirements for pharmacoepidemiological studies submitted to regulatory agencies to advance more effective utilization of real-world data 2019.International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH reflection paper: strategic approach to international harmonization of technical scientific requirements for pharmacoepidemiological studies submitted to regulatory agencies to advance more effective utilization of real-world data 2019.

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