Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness

被引:294
作者
Corrigan-Curay, Jacqueline [1 ]
Sacks, Leonard [1 ]
Woodcock, Janet [1 ]
机构
[1] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2018年 / 320卷 / 09期
关键词
TRIALS;
D O I
10.1001/jama.2018.10136
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
[No abstract available]
引用
收藏
页码:867 / 868
页数:2
相关论文
共 50 条
  • [41] Real-world evidence of bariatric surgery and cardiovascular benefits using electronic health records data: A lesson in bias
    Rassen, Jeremy A.
    Murk, William
    Schneeweiss, Sebastian
    [J]. DIABETES OBESITY & METABOLISM, 2021, 23 (07) : 1453 - 1462
  • [42] Time trends in mechanical thrombectomy (2017-2021): do real-world data reflect advances in evidence?
    Riegler, Christoph
    Ruecker, Viktoria
    von Rennenberg, Regina
    Bollweg, Kerstin
    Cheng, Bastian
    Alegiani, Anna C.
    Flottmann, Fabian
    Schnieder, Marlena
    Ernst, Marielle
    Pfeilschifter, Waltraud
    Kraemer, Christoffer
    Muehl-Benninghaus, Ruben
    Tiedt, Steffen
    Kellert, Lars
    Zimmermann, Hanna
    Bode, Felix J.
    Petzold, Gabor C.
    Dorn, Franziska
    Berrouschot, Joerg
    Bormann, Albrecht
    Bernkopf, Kathleen
    Wunderlich, Silke
    Boeckh-Behrens, Tobias
    Petersen, Martina
    Krause, Lars Udo
    Lowens, Stephan
    Audebert, Heinrich J.
    Siebert, Eberhard
    Heuschmann, Peter U.
    Nolte, Christian H.
    GSR ET Investigators
    [J]. FRONTIERS IN NEUROLOGY, 2025, 15
  • [43] Data processing and analysis in real-world traditional Chinese medicine clinical data: challenges and approaches
    Liu, Baoyan
    Zhou, Xuezhong
    Wang, Yinhui
    Hu, Jingqing
    He, Liyun
    Zhang, Runshun
    Chen, Shibo
    Guo, Yufeng
    [J]. STATISTICS IN MEDICINE, 2012, 31 (07) : 653 - 660
  • [44] For-profit Uses of Real-World Data: What Would Frances Kelsey Do?
    Zito, Julie M.
    Doshi, Peter
    [J]. MEDICAL CARE, 2016, 55 (12) : 1045 - 1047
  • [45] Why Does Primary Angioplasty Not Work in Registries? Quantifying the Susceptibility of Real-World Comparative Effectiveness Data to Allocation Bias
    Sen, Sayan
    Davies, Justin E.
    Malik, Iqbal S.
    Foale, Rodney A.
    Mikhail, Ghada W.
    Hadjiloizou, Nearchos
    Hughes, Alun
    Mayet, Jamil
    Francis, Darrel P.
    [J]. CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES, 2012, 5 (06): : 759 - 766
  • [46] Coronary lithoplasty for calcified lesions: real-world multicenter registry
    Cubero-Gallego, Hector
    Millan, Raul
    Fuertes, Monica
    Amat-Santos, Ignacio
    Quiroga, Xavier
    Gomez-Lara, Josep
    Salvatella, Neus
    Tizon-Marcos, Helena
    Negrete, Alejandro
    Santos-Martinez, Sandra
    Mohandes, Mohsen
    Gomez-Hospital, Joan A.
    Moris, Cesar
    Vaquerizo, Beatriz
    [J]. REVISTA ESPANOLA DE CARDIOLOGIA, 2020, 73 (12): : 1003 - 1010
  • [47] Retention Rate of Ixekizumab in Psoriatic Arthritis: A Real-World Study
    Bellis, Elisa
    Ruscitti, Piero
    Donzella, Denise
    Crepaldi, Gloria
    Data, Valeria
    Gammino, Marinella
    Gatto, Mariele
    Guardo, Valeria
    Lomater, Claudia
    Marucco, Elena
    Saracco, Marta
    Iagnocco, Annamaria
    [J]. JOURNAL OF PERSONALIZED MEDICINE, 2024, 14 (07):
  • [48] A prospective real-world analysis of erenumab in refractory chronic migraine
    Lambru, Giorgio
    Hill, Bethany
    Murphy, Madeleine
    Tylova, Ivona
    Andreou, Anna P.
    [J]. JOURNAL OF HEADACHE AND PAIN, 2020, 21 (01)
  • [49] Real-World Effectiveness of Dupilumab in Atopic Dermatitis Patients: Analysis of an Electronic Medical Records Dataset
    Eichenfield, Lawrence F.
    Armstrong, April
    Guttman-Yassky, Emma
    Lio, Peter A.
    Chen, Chi-Chang
    Hines, Dionne M.
    McGuiness, Catherine B.
    Ganguli, Sohini
    Delevry, Dimittri
    Sierka, Debra
    Mallya, Usha G.
    [J]. DERMATOLOGY AND THERAPY, 2022, 12 (06) : 1337 - 1350
  • [50] Real-world challenges in the diagnosis of primary progressive multiple sclerosis
    Blok, Katelijn M.
    Smolders, Joost
    van Rosmalen, Joost
    Jarnalo, Carine O. Martins
    Wokke, Beatrijs
    de Beukelaar, Janet
    [J]. EUROPEAN JOURNAL OF NEUROLOGY, 2023, 30 (12) : 3799 - 3808