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<article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" article-type="research-article" dtd-version="1.1d1" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher">REMEDIUM</journal-id><journal-title-group><journal-title>REMEDIUM</journal-title></journal-title-group><issn publication-format="print">1561-5936</issn><issn publication-format="electronic">2658-3534</issn><publisher><publisher-name>Joint-Stock Company Chicot</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">917</article-id><article-id pub-id-type="doi">10.21518/1561-5936-2020-1-2-3-3-9</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Article</subject></subj-group></article-categories><title-group><article-title>New Technologies in Real-World Data Analysis (RWD): challenges and potential solutions</article-title></title-group><contrib-group><contrib contrib-type="author"><name name-style="western"><surname>Samsonov</surname><given-names>M. Yu.</given-names></name><bio></bio><email>noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author"><name name-style="western"><surname>Pogrebnoy</surname><given-names>N. O.</given-names></name><bio></bio><email>noemail@neicon.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author"><name name-style="western"><surname>Vol’Skaya</surname><given-names>E. A.</given-names></name><bio></bio><email>noemail@neicon.ru</email><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff id="aff-1">R-Pharm</aff><aff id="aff-2">Semantic Hub</aff><aff id="aff-3">Independent Interdisciplinary Committee for the Ethical Review of Clinical Research</aff><pub-date date-type="epub" iso-8601-date="2020-12-01" publication-format="electronic"><day>01</day><month>12</month><year>2020</year></pub-date><issue>1-3</issue><fpage>3</fpage><lpage>9</lpage><history><pub-date date-type="received" iso-8601-date="2022-03-18"><day>18</day><month>03</month><year>2022</year></pub-date></history><permissions><copyright-statement>Copyright © 2020,</copyright-statement><copyright-year>2020</copyright-year></permissions><abstract>Real World Data (RWD) offer the possibility to derive a more complete understanding of the use of medicines in everyday clinical practice, complementing rather than competing with evidence from traditional randomized clinical trials. Government regulators of the world’s leading economies and pharmaceutical manufacturers recognize the growing contribution of DRM to understanding of the lifecycle of medicines and patient needs. This overview of DRM development trends provides a thorough introduction to a variety of technological and methodological innovations, as well as potential ways of their application in the pharmaceutical industry.</abstract><kwd-group xml:lang="en"><kwd>real world data</kwd><kwd>practice-based evidence</kwd><kwd>natural language understanding</kwd><kwd>prospective studies</kwd><kwd>structured and unstructured data</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>Данные реального мира</kwd><kwd>доказательства реальной практики</kwd><kwd>понимание естественного языка</kwd><kwd>проспективные исследования</kwd><kwd>структурированные и неструктурированные данные</kwd></kwd-group></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><mixed-citation>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.</mixed-citation></ref><ref id="B2"><label>2.</label><mixed-citation>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</mixed-citation></ref><ref id="B3"><label>3.</label><mixed-citation>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.</mixed-citation></ref><ref id="B4"><label>4.</label><mixed-citation>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.</mixed-citation></ref><ref id="B5"><label>5.</label><mixed-citation>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.</mixed-citation></ref><ref id="B6"><label>6.</label><mixed-citation>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.</mixed-citation></ref><ref id="B7"><label>7.</label><mixed-citation>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.</mixed-citation></ref><ref id="B8"><label>8.</label><mixed-citation>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.</mixed-citation></ref><ref id="B9"><label>9.</label><mixed-citation>PDUFA reauthorization performance goals and procedures fiscal years 2018 through 2022. Available at: https://www.fda.gov/ media/99140/download.</mixed-citation></ref><ref id="B10"><label>10.</label><mixed-citation>https://www.fda.gov/regulatory-information/selected-amend- ments-fdc-act/21st-century-cures-act.</mixed-citation></ref><ref id="B11"><label>11.</label><mixed-citation>https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-perspective-real-world-evidence-rwe-scientific-advice-emas-pcwp-hcpwp-joint_en.pdf.</mixed-citation></ref><ref id="B12"><label>12.</label><mixed-citation>https://hitconsultant.net/2019/02/27/state-of-ehr-data-real-world-evidence-rwe/#.XbfwcJMzbOQ.</mixed-citation></ref><ref id="B13"><label>13.</label><mixed-citation>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.</mixed-citation></ref><ref id="B14"><label>14.</label><mixed-citation>https://www.pipaonline.org/Interim-Guidance-Notes-on-UK- Data-Protection-in-Post-Marketing-Pharmacovigilance.</mixed-citation></ref><ref id="B15"><label>15.</label><mixed-citation>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.</mixed-citation></ref><ref id="B16"><label>16.</label><mixed-citation>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.</mixed-citation></ref><ref id="B17"><label>17.</label><mixed-citation>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.</mixed-citation></ref><ref id="B18"><label>18.</label><mixed-citation>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.</mixed-citation></ref><ref id="B19"><label>19.</label><mixed-citation>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/.</mixed-citation></ref><ref id="B20"><label>20.</label><mixed-citation>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.</mixed-citation></ref><ref id="B21"><label>21.</label><mixed-citation>Evers M., Ghatak A., Suresh B., Westra A. et al. A vision for medical affairs in 2025. McKinsey &amp; Company; 2019. Available at: https:// www.mckinsey.com/industries/pharmaceuticals-and-medical- products/our-insights/a-vision-for-medical-affairs-in-2025.</mixed-citation></ref><ref id="B22"><label>22.</label><mixed-citation>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.</mixed-citation></ref><ref id="B23"><label>23.</label><mixed-citation>National Institutes of Health, Healthcare Systems Research Collaboratory, «About us», nihcollaboratory.org. Accessed September 15, 2016.</mixed-citation></ref><ref id="B24"><label>24.</label><mixed-citation>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.</mixed-citation></ref><ref id="B25"><label>25.</label><mixed-citation>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.</mixed-citation></ref><ref id="B26"><label>26.</label><mixed-citation>Cavlan O., Chilukuri S., Evers M., Westra A. Real-world evidence: From activity to impact in healthcare decision making. McKinsey &amp; 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.</mixed-citation></ref><ref id="B27"><label>27.</label><mixed-citation>https://www.oecd.org/health/ministerial/ministerial-statement-2017.pdf.</mixed-citation></ref></ref-list></back></article>
