NICE guidance to working with real-world data
https://doi.org/10.37489/2782-3784-myrwd-25
EDN: HKMZFA
Abstract
This article provides a brief overview of the key aspects of planning, conducting, and reporting NICE clinical practice data collection and analysis studies, as well as general information about the sources of real-world data (RWD) and their use in NICE management decision-making algorithms. The difficulties of finding and using RWD are described, as well as methods for overcoming them, brief NICE recommendations for assessing the suitability of data and an algorithm for conducting quantitative studies to collect evidence from RWD are given.
About the Authors
A. Sh. Motrinchuk
Federal State Budgetary Educational Institution of Higher Education «First St. Petersburg State Medical University named after Academician I. P. Pavlov» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
Motrinchuk Aiten S. — resident of the department of Clinical Pharmacology and Evidence-Based Medicine
St. Petersburg
A. R. Kasimova
Federal State Budgetary Educational Institution of Higher Education «First St. Petersburg State Medical University named after Academician I. P. Pavlov» of the Ministry of Health of the Russian Federation; Federal State Budgetary Institution «National Medical Research Center for Traumatology and Orthopedics named after R. R. Vreden» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
Kasimova Alina R. — PhD, associate professor of the department of Clinical Pharmacology and Evidence Based Medicine; Clinical pharmacologist of the Department of Clinical Pharmacology
St. Petersburg
E. A. Novoderezhkina
LLC «Novartis Pharma»
Russian Federation
Russian Federation
Novoderezhkina Evgeniya A. — Senior Real World Evidence Manager
Moscow
References
1. NICE real-world evidence framework. Corporate document [ECD9]. Published: 23 June 2022. https://www.nice.org.uk / corporate / ecd9 / chapter / overview.
2. Makady A, van Veelen A, Jonsson P, Moseley O, D´Andon A, de Boer A, Hillege H, Klungel O, Goettsch W. Using Real-World Data in Health Technology Assessment (HTA) Practice: A Comparative Study of Five HTA Agencies. Pharmacoeconomics. 2018 Mar;36 (3):359-68. doi: 10.1007 / s40273-017-0596-z. PMID: 29214389; PMCID: PMC5834594.
3. Leahy TP, Ramagopalan SC. The use of UK primary care databases in health technology assessments carried out by the National Institute for health and care excellence (NICE). BMC Health Serv Res. 2020;20:675. https://doi.org / 10.1186 / s12913-020-05529-3.
4. Shevchenko OR, Kolbin AS. Pragmatic clinical trials. Kachestvennaya klinicheskaya praktika = Good Clinical Practice. 2020; (3):52-60. (In Russ.).
5. Kasimova AR, Kolbin AS. Real-world evidence market: key players and key segments. Real-World Data & Evidence. 2022;2 (1):40-3. (In Russ.).
Review
For citations:
Motrinchuk A.Sh., Kasimova A.R., Novoderezhkina E.A. NICE guidance to working with real-world data. Real-World Data & Evidence. 2022;2(4):34-44. (In Russ.) https://doi.org/10.37489/2782-3784-myrwd-25. EDN: HKMZFA
Views:
1529
Email this article 
Post a Comment 