Preview

Ремедиум

Расширенный поиск

Новые технологии в области анализа Данных реального мира (RWD): вопросы и перспективы

https://doi.org/10.21518/1561-5936-2020-1-2-3-3-9

Полный текст:

Аннотация

Данные реального мира (ДРМ - Real World Data (RWD)), дополняя традиционные рандомизированные клинические исследования, но не конкурируя с ними, позволяют получить более полное представление об использовании лекарственных средств в повседневной клинической практике. Регуляторные агентства ведущих экономик мира и производители лекарственных средств признают растущий вклад ДРМ в обеспечение понимания жизненного цикла лекарственных препаратов и потребностей пациентов. Данный обзор тенденций развития ДРМ знакомит читателя с многообразием технологических и методологических инноваций, а также потенциальных путей их применения в рамках фармацевтической индустрии.

Об авторах

М. Ю. Самсонов
«Р-Фарм»
Россия


Н. О. Погребной
Semantic Hub
Россия


Е. А. Вольская
Независимый междисциплинарный Комитет по этической экспертизе клинических исследований
Россия


Список литературы

1. Sherman R.E., Davies K.M., Robb M.A., Hunter N.L., Califf R.M. Accelerating development of scientific evidence for medical products within the existing US regulatory framework. Nature Reviews Drug Discovery. 2017;(16):297-298. Available at: https://www. nature.com/articles/nrd.2017.25#supplementary-information.

2. Tremoulet A., Le J., Poindexter B,, Sullivan J.E., et al. Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design. Antimicrob Agents Chemother. 2014;(58):3013-3020. doi: 10.1128/AAC.02374-13

3. Borrelli F., Izzo A.A. Herbdrug interactions with St John’s wort (Hypericum perforatum): an update on clinical observations. AAPS J. 2009;(11):710-727. doi: 10.1208/s12248-009-9146-8.

4. Kish J.K., Ward M.A., Garofalo D., et al. Real-world evidence analysis of palbociclib prescribing patterns for patients with advanced/ metastatic breast cancer treated in community oncology practice in the USA one year post approval. Breast Cancer Res. 2018;(20):37. doi: 10.1186/s13058-018-0958-2.

5. Pacurariu A., Plueschke K., McGettigan P., et al. Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation. BMJ Open. 2018;(8):e023090. doi: 10.1136/bmjopen-2018-023090.

6. Cave А., Kurz Х., Arlett R. Real World data for regulatory decision making: challenges and possible solutions for Europe. Clin Pharmacol Ther. 2019;106(1):36-39. doi: 10.1002/cpt.1426.

7. US Food and Drug Administration. Framework for FDA’s RealWorld Evidence Program. December 2018. Available at: https:// www.fda.gov/media/120060/download. Accessed September 5, 2019.

8. Вольская Е., Александрова О. Защита персональных данных пациентов. Ремедиум. 2018;(10):6-11. doi: 10.21518/1561-5936-2018- 10-6-11. @@ Volskaya E., Aleksandrova O. Protecting personal data respecting patients’ privacy. Remedium. 2018;(10):6-11. (In Russ.) doi: 10.21518/1561-5936-2018-10-6-11.

9. PDUFA reauthorization performance goals and procedures fiscal years 2018 through 2022. Available at: https://www.fda.gov/ media/99140/download.

10. https://www.fda.gov/regulatory-information/selected-amend- ments-fdc-act/21st-century-cures-act.

11. https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-perspective-real-world-evidence-rwe-scientific-advice-emas-pcwp-hcpwp-joint_en.pdf.

12. https://hitconsultant.net/2019/02/27/state-of-ehr-data-real-world-evidence-rwe/#.XbfwcJMzbOQ.

13. Fralick M., Kesselheim A.S., Avorn J., Schneeweiss S. Use of Health Care Databases to Support Supplemental Indications of Approved Medications. JAMA Intern Med. 2018;178(1):55-63. doi: 10.1001/jamainternmed.2017.3919.

14. https://www.pipaonline.org/Interim-Guidance-Notes-on-UK- Data-Protection-in-Post-Marketing-Pharmacovigilance.

15. Morton S.C., Costlow M.R., Graff J.S. et al. Standards and guidelines for observational studies: quality is in the eye of the beholder. J Clin Epidemiol. 2016;(71):3-10. doi: 10.1016/j.jclinepi.2015.10.014.

16. Liu X., Rivera S.C., Faes L. et al. Reporting guidelines for clinical trials evaluating artificial intelligence interventions are needed. Nat Med. 2019;(25):1467-1468. doi: 10.1038/s41591-019-0603-3.

17. HMA. EU Medicines Agencies Network Strategy to 2020 - Working together to improve health. 2015 http://www.ema. europa.eu/docs/ en_GB/document_library/Other/2015/12/ WC500199060.pdf.

18. Plueschke K., McGettigan P., Pacurariu A. et al. EU-funded initiatives for real world evidence: descriptive analysis of their characteristics and relevance for regulatory decisionmaking. BMJ Open. 2018;8(6):e021864. doi: 10.1136/bmjopen-2018-021864.

19. Iiro Toppila. Possibilities of machine learning and artificial intelligence in RWE studies. Future care Finland. 2018;April 8. Available at: https://futurecarefinland.fi/2018/04/possibilities-of-machine- learning-and-artificial-intelligence-in-rwe-studies/.

20. Real World Evidence Solutions Market by Component (RWD, EMR, Claim, Patient Registry, Pharmacy, Service), Application (Oncology, CVD, Neuro, Infection, Regulatory), End User (Pharma, Biotech, Medical Devices, Payers, Healthcare) - Global Forecast to 2024. Meticulous Market Research Pvt. Ltd.; 2019. 166 p. Available at: https://www.researchandmarkets.com/reports/4755940/real- world-evidence-rwe-solutions-market-by.

21. Evers M., Ghatak A., Suresh B., Westra A. et al. A vision for medical affairs in 2025. McKinsey & Company; 2019. Available at: https:// www.mckinsey.com/industries/pharmaceuticals-and-medical- products/our-insights/a-vision-for-medical-affairs-in-2025.

22. Paparrizos J., White R.W., Horvitz E. Screening for pancreatic adenocarcinoma using signals from web search logs: Feasibility study and results. J Oncol Pract. 2016;12(8):737-744. doi: 10.1200/ JOP.2015.010504.

23. National Institutes of Health, Healthcare Systems Research Collaboratory, «About us», nihcollaboratory.org. Accessed September 15, 2016.

24. Stegenga H. Finding answers in the real world. 24 March 2017. Available at: https://www.nice.org.uk/news/blog/finding- answers-in-the-real-world.

25. Bezin J., Duong M., Lassalle R. et al. The national healthcare sys- tem claims databases in France, SNIIRAM and EGB: Powerful tools for pharmacoepidemiology. PDS. 2017;26(8):954-962. doi: 10.1002/pds.4233.

26. Cavlan O., Chilukuri S., Evers M., Westra A. Real-world evidence: From activity to impact in healthcare decision making. McKinsey & Company; 2018. Available at: https://www.mckinsey.com/indus- tries/pharmaceuticals-and-medical-products/our-insights/real-world-evidence-from-activity-to-impact-in-healthcare-decision- making.

27. https://www.oecd.org/health/ministerial/ministerial-statement-2017.pdf.


Для цитирования:


Самсонов М.Ю., Погребной Н.О., Вольская Е.А. Новые технологии в области анализа Данных реального мира (RWD): вопросы и перспективы. Ремедиум. 2020;(1-3):3-9. https://doi.org/10.21518/1561-5936-2020-1-2-3-3-9

For citation:


Samsonov M.Yu., Pogrebnoy N.O., Vol’Skaya E.A. New Technologies in Real-World Data Analysis (RWD): challenges and potential solutions. Remedium. 2020;(1-3):3-9. (In Russ.) https://doi.org/10.21518/1561-5936-2020-1-2-3-3-9

Просмотров: 72


Creative Commons License
Контент доступен под лицензией Creative Commons Attribution 4.0 License.


ISSN 1561-5936 (Print)
ISSN 2658-3534 (Online)