Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medica Records

被引:256
作者
Kim, Hun-Sung [1 ,2 ]
Lee, Suehyun [3 ]
Kim, Ju Han [3 ]
机构
[1] Catholic Univ Korea, Dept Med Informat, Coll Med, Seoul, South Korea
[2] Catholic Univ Korea, Coll Med, Div Endocrinol & Metab, Dept Internal Med,Seoul St Marys Hosp, Seoul, South Korea
[3] Seoul Natl Univ, Syst Biomed Informat Res Ctr, Div Biomed Informat, Coll Med, 103 Daehak Ro, Seoul 03080, South Korea
关键词
Real-world Evidence; Randomized Control Trial; Real-world Data; LIPOPROTEIN CHOLESTEROL LEVEL; MODERATE-INTENSITY STATINS; LINE; PHARMACOVIGILANCE; EFFICACY; OUTCOMES; HEALTH; BIAS;
D O I
10.3346/jkms.2018.33.e213
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Real-world evidence (RWE) and randomized control trial (RCT) data are considered mutually complementary. However, compared with RCT, the outcomes of RWE continue to be assigned lower credibility. It must be emphasized that RWE research is a real-world practice that does not need to be executed as RCT research for it to be reliable. The advantages and disadvantages of RWE must be discerned clearly, and then the proper protocol can be planned from the beginning of the research to secure as many samples as possible. Attention must be paid to privacy protection. Moreover, bias can be reduced meaningfully by reducing the number of dropouts through detailed and meticulous data quality management. RCT research, characterized as having the highest reliability, and RWE research, which reflects the actual clinical aspects, can have a mutually supplementary relationship. Indeed, once this is proven, the two could comprise the most powerful evidence-based research method in medicine.
引用
收藏
页数:7
相关论文
共 28 条
[1]   Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project [J].
Coloma, Preciosa M. ;
Schuemie, Martijn J. ;
Trifiro, Gianluca ;
Gini, Rosa ;
Herings, Ron ;
Hippisley-Cox, Julia ;
Mazzaglia, Giampiero ;
Giaquinto, Carlo ;
Corrao, Giovanni ;
Pedersen, Lars ;
van der Lei, Johan ;
Sturkenboom, Miriam .
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2011, 20 (01) :1-11
[2]   Trends in Primary Care Clinician Perceptions of a New Electronic Health Record [J].
El-Kareh, Robert ;
Gandhi, Tejal K. ;
Poon, Eric G. ;
Newmark, Lisa P. ;
Ungar, Jonathan ;
Lipsitz, Stuart ;
Sequist, Thomas D. .
JOURNAL OF GENERAL INTERNAL MEDICINE, 2009, 24 (04) :464-468
[3]   Using real-world data for coverage and payment decisions: The ISPOR real-world data task force report [J].
Garrison, Louis P., Jr. ;
Neumann, Peter J. ;
Erickson, Pennifer ;
Marshall, Deborah ;
Mullins, Daniel .
VALUE IN HEALTH, 2007, 10 (05) :326-335
[4]   Conflicts of interest in biomedical publications: considerations for authors, peer reviewers, and editors [J].
Gasparyan, Armen Yuri ;
Ayvazyan, Lilit ;
Akazhanov, Nurbek A. ;
Kitas, George D. .
CROATIAN MEDICAL JOURNAL, 2013, 54 (06) :600-608
[5]  
Hanna K., 2005, THINK RES USING ELEC
[6]   Data mining in pharmacovigilance - The need for a balanced perspective [J].
Hauben, M ;
Patadia, V ;
Gerrits, C ;
Walsh, L ;
Reich, L .
DRUG SAFETY, 2005, 28 (10) :835-842
[7]   Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects [J].
James, W. Philip T. ;
Caterson, Ian D. ;
Coutinho, Walmir ;
Finer, Nick ;
Van Gaal, Luc F. ;
Maggioni, Aldo P. ;
Torp-Pedersen, Christian ;
Sharma, Arya M. ;
Shepherd, Gillian M. ;
Rode, Richard A. ;
Renz, Cheryl L. .
NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (10) :905-917
[8]   Analysis and comparison of the cost-effectiveness of statins according to the baseline low-density lipoprotein cholesterol level in Korea [J].
Jeong, Y. J. ;
Kim, H. ;
Baik, S. J. ;
Kim, T. M. ;
Yang, S. J. ;
Lee, S. -H. ;
Cho, J. -H. ;
Lee, H. ;
Yim, H. W. ;
Choi, I. Y. ;
Yoon, K. -H. ;
Kim, H. -S. .
JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS, 2017, 42 (03) :292-300
[9]   Comparative analysis of the efficacy of omega-3 fatty acids for hypertriglyceridaemia management in Korea [J].
Kim, H. -S. ;
Kim, H. ;
Jeong, Y. J. ;
Yang, S. J. ;
Baik, S. J. ;
Lee, H. ;
Lee, S. -H. ;
Cho, J. H. ;
Choi, I. -Y. ;
Yim, H. W. ;
Yoon, K. -H. .
JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS, 2016, 41 (05) :508-514
[10]   Statin-related aminotransferase elevation according to baseline aminotransferases level in real practice in Korea [J].
Kim, H. -S. ;
Lee, S. H. ;
Kim, H. ;
Lee, S. -H. ;
Cho, J. H. ;
Lee, H. ;
Yim, H. W. ;
Kim, S. -H. ;
Choi, I. -Y. ;
Yoon, K. -H. ;
Kim, J. H. .
JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS, 2016, 41 (03) :266-272