STaRT-RWE: structured template for planning and reporting on the implementation of real-world evidence studies
https://doi.org/10.37489/2782-3784-myrwd-19
EDN: GBRMFZ
Abstract
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. 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. 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. 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.
About the Authors
S. L. Plavinskij
North-Western State Medical University named after I. I. Mechnikov
Russian Federation
Competing Interests:
Russian Federation
Plavinskij Sviatoslav L. — MD, PhD, DSc, profes- sor of the Department of Teaching, Philosophy and Law
Saint Petersburg
Competing Interests:
The authors declare no conflict of interest.
A. N. Barinova
North-Western State Medical University named after I. I. Mechnikov
Russian Federation
Competing Interests:
Russian Federation
Barinova Anna N. — MD, PhD, DSc, professor of the Department of public health and health admin- istration
Saint Petersburg
Competing Interests:
The authors declare no conflict of interest.
References
1. 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.
2. 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.j5262
3. Charter 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.2016.09.2046
4. Li 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.2016.08.003
5. US Food and Drug Administration. FDA’s Sentinel Initiative. 2016.
6. 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.x
7. Ko 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)41026-8
8. 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.
9. 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.2016.12.003
10. Oyinlola 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/s12913-016-1562-8
11. 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.).
12. 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.329
13. Wang 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 464
14. 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.
Review
For citations:
Plavinskij S.L., Barinova A.N. STaRT-RWE: structured template for planning and reporting on the implementation of real-world evidence studies. Real-World Data & Evidence. 2022;2(3):20-34. (In Russ.) https://doi.org/10.37489/2782-3784-myrwd-19. EDN: GBRMFZ
Views:
753
Email this article 
Post a Comment 