These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
257 related articles for article (PubMed ID: 29714518)
1. Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights. Marchenko O; Russek-Cohen E; Levenson M; Zink RC; Krukas-Hampel MR; Jiang Q Ther Innov Regul Sci; 2018 Mar; 52(2):170-186. PubMed ID: 29714518 [TBL] [Abstract][Full Text] [Related]
2. Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical Trials. Zink RC; Marchenko O; Sanchez-Kam M; Ma H; Jiang Q Ther Innov Regul Sci; 2018 Mar; 52(2):141-158. PubMed ID: 29714519 [TBL] [Abstract][Full Text] [Related]
3. Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance. Izem R; Sanchez-Kam M; Ma H; Zink R; Zhao Y Ther Innov Regul Sci; 2018 Mar; 52(2):159-169. PubMed ID: 29714520 [TBL] [Abstract][Full Text] [Related]
4. It is important to note that RWD will never replace the more traditional and more robust RCT data; however, the emerging trend is to incorporate data that are more generalizable. Introduction. Mullins CD; Sanchez RJ J Manag Care Pharm; 2011; 17(9 Suppl A):S03-4. PubMed ID: 22074667 [TBL] [Abstract][Full Text] [Related]
5. Trial designs using real-world data: The changing landscape of the regulatory approval process. Baumfeld Andre E; Reynolds R; Caubel P; Azoulay L; Dreyer NA Pharmacoepidemiol Drug Saf; 2020 Oct; 29(10):1201-1212. PubMed ID: 31823482 [TBL] [Abstract][Full Text] [Related]
6. Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence. Ma H; Russek-Cohen E; Izem R; Marchenko OV; Jiang Q Ther Innov Regul Sci; 2018 Mar; 52(2):187-198. PubMed ID: 29714524 [TBL] [Abstract][Full Text] [Related]
7. Real-world evidence to support regulatory decision-making for medicines: Considerations for external control arms. Burcu M; Dreyer NA; Franklin JM; Blum MD; Critchlow CW; Perfetto EM; Zhou W Pharmacoepidemiol Drug Saf; 2020 Oct; 29(10):1228-1235. PubMed ID: 32162381 [TBL] [Abstract][Full Text] [Related]
8. Hybrid clinical trials to generate real-world evidence: design considerations from a sponsor's perspective. Zhu M; Sridhar S; Hollingsworth R; Chit A; Kimball T; Murmello K; Greenberg M; Gurunathan S; Chen J Contemp Clin Trials; 2020 Jul; 94():105856. PubMed ID: 31669449 [TBL] [Abstract][Full Text] [Related]
9. The Aetion Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation Initiative: Oncology. Merola D; Campbell U; Gautam N; Rubens A; Schneeweiss S; Wang SV; Carrigan G; Chia V; Ovbiosa OE; Pinheiro S; Bruno A; Jiao X; Stewart M; Hendricks-Sturrup R; Rodriguez-Watson C; Khosla S; Zhang Y; Rimawi M; Huang J; Taylor A; Becnel L; McRoy L; Eckert J; Taylor B Clin Pharmacol Ther; 2023 Jun; 113(6):1217-1222. PubMed ID: 36408668 [TBL] [Abstract][Full Text] [Related]
10. The respective roles of controlled clinical trials and cohort monitoring studies in the pre- and postmarketing assessment of drugs. Vray M; Hamelin B; Jaillon P; Therapie; 2005; 60(4):339-44, 345-9. PubMed ID: 16268434 [TBL] [Abstract][Full Text] [Related]
11. Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey. Facile R; Muhlbradt EE; Gong M; Li Q; Popat V; Pétavy F; Cornet R; Ruan Y; Koide D; Saito TI; Hume S; Rockhold F; Bao W; Dubman S; Jauregui Wurst B JMIR Med Inform; 2022 Jan; 10(1):e30363. PubMed ID: 35084343 [TBL] [Abstract][Full Text] [Related]
12. What Is Real-World Data? A Review of Definitions Based on Literature and Stakeholder Interviews. Makady A; de Boer A; Hillege H; Klungel O; Goettsch W; Value Health; 2017; 20(7):858-865. PubMed ID: 28712614 [TBL] [Abstract][Full Text] [Related]
13. Pragmatic clinical trials in the context of regulation of medicines. Gedeborg R; Cline C; Zethelius B; Salmonson T Ups J Med Sci; 2019 Jan; 124(1):37-41. PubMed ID: 30251577 [TBL] [Abstract][Full Text] [Related]
14. Introduction to the Special Section for Sources of Safety Data and Statistical Strategies for Design and Analysis. Zink RC Ther Innov Regul Sci; 2018 Mar; 52(2):140. PubMed ID: 29714517 [No Abstract] [Full Text] [Related]
15. When and How Can Real World Data Analyses Substitute for Randomized Controlled Trials? Franklin JM; Schneeweiss S Clin Pharmacol Ther; 2017 Dec; 102(6):924-933. PubMed ID: 28836267 [TBL] [Abstract][Full Text] [Related]
16. Use of Real-World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design. Dagenais S; Russo L; Madsen A; Webster J; Becnel L Clin Pharmacol Ther; 2022 Jan; 111(1):77-89. PubMed ID: 34839524 [TBL] [Abstract][Full Text] [Related]
17. Estimation of causal effect in integrating randomized clinical trial and observational data - An example application to cardiovascular outcome trial. Zhang Y; Lin LA; Starkopf L; Chen J; Wang WWB Contemp Clin Trials; 2021 Aug; 107():106492. PubMed ID: 34175491 [TBL] [Abstract][Full Text] [Related]
18. Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013-2017. Brown JP; Wing K; Evans SJ; Bhaskaran K; Smeeth L; Douglas IJ BMJ Open; 2019 Oct; 9(10):e028133. PubMed ID: 31662354 [TBL] [Abstract][Full Text] [Related]
19. Series: Pragmatic trials and real world evidence: Paper 7. Safety, quality and monitoring. Irving E; van den Bor R; Welsing P; Walsh V; Alfonso-Cristancho R; Harvey C; Garman N; Grobbee DE; J Clin Epidemiol; 2017 Nov; 91():6-12. PubMed ID: 28502812 [TBL] [Abstract][Full Text] [Related]