TY - JOUR
T1 - Randomized controlled trials and real-world data
T2 - differences and similarities to untangle literature data
AU - Monti, Sara
AU - Grosso, Vittorio
AU - Todoerti, Monica
AU - Caporali, Roberto
PY - 2018/10/1
Y1 - 2018/10/1
N2 - Randomized controlled trials (RCTs) represent the gold-standard of medical evidence to assess the efficacy and safety of therapeutic interventions. However, the need to minimize bias and ensure the correct design to explore the study aims often affects the generalizability of results. As a consequence, the evidence derived from the most rigorous research strategy available is not always representative of the real-world settings for which this evidence is ultimately intended. Observational studies, in contrast, although affected by a number of potential confounders, can more effectively capture treatment characteristics and safety issues that had not been identified by previous RCTs, owing to the short duration of follow-up or highly selective inclusion criteria. The aim of this review is to provide a comparative summary of the main advantages and pitfalls of RCTs and real-world data, emphasizing the need for a constant integration of all available levels of evidence to provide the best care for patients.
AB - Randomized controlled trials (RCTs) represent the gold-standard of medical evidence to assess the efficacy and safety of therapeutic interventions. However, the need to minimize bias and ensure the correct design to explore the study aims often affects the generalizability of results. As a consequence, the evidence derived from the most rigorous research strategy available is not always representative of the real-world settings for which this evidence is ultimately intended. Observational studies, in contrast, although affected by a number of potential confounders, can more effectively capture treatment characteristics and safety issues that had not been identified by previous RCTs, owing to the short duration of follow-up or highly selective inclusion criteria. The aim of this review is to provide a comparative summary of the main advantages and pitfalls of RCTs and real-world data, emphasizing the need for a constant integration of all available levels of evidence to provide the best care for patients.
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U2 - 10.1093/rheumatology/key109
DO - 10.1093/rheumatology/key109
M3 - Article
C2 - 30289534
AN - SCOPUS:85054422371
VL - 57
SP - vii54-vii58
JO - Rheumatology
JF - Rheumatology
SN - 1462-0324
IS - 7
ER -