TY - JOUR
T1 - Real-world evidence versus randomized controlled trial
T2 - Clinical research based on electronic medical records
AU - Kim, Hun Sung
AU - Lee, Suehyun
AU - Kim, Ju Han
N1 - Publisher Copyright:
© 2018 The Korean Academy of Medical Sciences.
PY - 2018/8/1
Y1 - 2018/8/1
N2 - 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.
AB - 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.
KW - Randomized control trial
KW - Real-world data
KW - Real-world evidence
UR - http://www.scopus.com/inward/record.url?scp=85052074381&partnerID=8YFLogxK
U2 - 10.3346/jkms.2018.33.e213
DO - 10.3346/jkms.2018.33.e213
M3 - Article
C2 - 30127705
AN - SCOPUS:85052074381
SN - 1011-8934
VL - 33
JO - Journal of Korean Medical Science
JF - Journal of Korean Medical Science
IS - 34
M1 - e213
ER -