Emulation Differences vs. Biases When Calibrating Real-World Evidence Findings Against Randomized Controlled Trials

被引:35
|
作者
Franklin, Jessica M. [1 ]
Glynn, Robert J. [1 ]
Suissa, Samy [2 ,3 ,4 ]
Schneeweiss, Sebastian [1 ]
机构
[1] Harvard Med Sch, Brigham & Womens Hosp, Dept Med, Div Pharmacoepidemiol & Pharmacoecon, Boston, MA 02115 USA
[2] McGill Univ, Dept Epidemiol, Montreal, PQ, Canada
[3] McGill Univ, Dept Biostat, Montreal, PQ, Canada
[4] McGill Univ, Dept Occupat Hlth, Montreal, PQ, Canada
关键词
D O I
10.1002/cpt.1793
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Actionable real-world evidence (RWE) requires accurate estimation of causal treatment effects. Calibration of RWE against randomized controlled trials (RCTs) is sometimes done to demonstrate that RWE can support the same causal conclusion as RCTs. Disagreements can occur when studies in each pair asked different questions in different populations or due to the presence of residual bias. Distinguishing among reasons for differences will impact the level of confidence in RWE.
引用
收藏
页码:735 / 737
页数:3
相关论文
共 50 条
  • [41] Randomized controlled trials and real-world evidence for the market access and surveillance of high-risk products-the example of paclitaxel
    Behrendt, C-A
    Rother, U.
    Ruemenapf, G.
    Uhl, C.
    Goertz, H.
    Boeckler, D.
    GEFASSCHIRURGIE, 2021, 26 (02): : 110 - 117
  • [42] Generating real-world evidence compatible with evidence from randomized controlled trials: a novel observational study design applicable to surgical transfusion research
    Yu, Xiaochu
    Wang, Zixing
    Wang, Lei
    Huang, Yuguang
    Wang, Yipeng
    Xin, Shijie
    Lei, Guanghua
    Zhao, Shengxiu
    Chen, Yali
    Guo, Xiaobo
    Han, Wei
    Yu, Xuerong
    Xue, Fang
    Wu, Peng
    Gu, Wentao
    Jiang, Jingmei
    BMC MEDICAL RESEARCH METHODOLOGY, 2022, 22 (01)
  • [43] Generating real-world evidence compatible with evidence from randomized controlled trials: a novel observational study design applicable to surgical transfusion research
    Xiaochu Yu
    Zixing Wang
    Lei Wang
    Yuguang Huang
    Yipeng Wang
    Shijie Xin
    Guanghua Lei
    Shengxiu Zhao
    Yali Chen
    Xiaobo Guo
    Wei Han
    Xuerong Yu
    Fang Xue
    Peng Wu
    Wentao Gu
    Jingmei Jiang
    BMC Medical Research Methodology, 22
  • [44] Glargine-300: An updated literature review on randomized controlled trials and real-world studies
    Ghosh, Sujoy
    Ghosh, Romik
    WORLD JOURNAL OF DIABETES, 2020, 11 (04) : 100 - 114
  • [45] Replication of Randomized, Controlled Trials Using Real-World Data: What Could Go Wrong?
    Thompson, David
    VALUE IN HEALTH, 2021, 24 (01) : 112 - 115
  • [46] Comparing Randomized Controlled Trials and Real-World Studies in Chronic Obstructive Pulmonary Disease Pharmacotherapy
    Tashkin, Donald P.
    Amin, Alpesh N.
    Kerwin, Edward M.
    INTERNATIONAL JOURNAL OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, 2020, 15 : 1225 - 1243
  • [47] Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials
    Wallach, Joshua D.
    Deng, Yihong
    Polley, Eric C.
    Dhruva, Sanket S.
    Herrin, Jeph
    Quinto, Kenneth
    Gandotra, Charu
    Crown, William
    Noseworthy, Peter
    Yao, Xiaoxi
    Jeffery, Molly Moore
    Lyon, Timothy D.
    Ross, Joseph S.
    McCoy, Rozalina G.
    CLINICAL TRIALS, 2023, 20 (06) : 689 - 698
  • [48] Intention-to-treat analysis in partially nested randomized controlled trials with real-world complexity
    Schweig, Jonathan David
    Pane, John F.
    INTERNATIONAL JOURNAL OF RESEARCH & METHOD IN EDUCATION, 2016, 39 (03) : 268 - 286
  • [49] Clear Improvement in Real-World Chronic Myeloid Leukemia Survival: A Comparison With Randomized Controlled Trials
    Vener, Claudia
    Rossi, Silvia
    Minicozzi, Pamela
    Marcos-Gragera, Rafael
    Poirel, Helene A.
    Maynadie, Marc
    Troussard, Xavier
    Pravettoni, Gabriella
    De Angelis, Roberta
    Sant, Milena
    FRONTIERS IN ONCOLOGY, 2022, 12
  • [50] Randomized controlled trials do not reflect reality: Real-world analyses are critical for treatment guidelines!
    Grapow, MTR
    von Wattenwyl, R
    Guller, U
    Beyersdorf, F
    Zerkowski, HR
    JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 2006, 132 (01): : 5 - 7