RCTs and real world evidence are complementary, not alternatives

Very‐high frequency plasmapheresis and donor health–absence of evidence is not equal to evidence of absence

“…6,7 We advocate that RCTs together with analyses of real-world data (via improved epidemiological designs and methods to control for biases) are complementary and serve as the most robust study designs to investigate the efficacy, effectiveness, and safety of repeated plasmapheresis. 8 However, it is highly concerning that the authors draw conclusions about causality using a study design inherently unsuitable for such claims.…”

Optimising Real-World Evidence Studies for Regulatory Decision-Making and Impact Assessment in Pharmacovigilance

“…In post-marketing surveillance, RWE on the effectiveness and safety profile supplements the existing evidence from preclinical studies and clinical trials and can provide post-approval guidance. 6 Once a drug has reached the market, continuous monitoring is vital to detect any possible adverse reactions timely. It is imperative to study how drugs perform in real life, especially in groups of patients that are under-represented in clinical trials, such as older adults, paediatric populations, pregnant or breastfeeding individuals, and people with multiple chronic and complex conditions.…”

Long term effectiveness of live herpes zoster vaccine

“…Klein and colleagues’ new research is an excellent example of a real world observational study, using high quality health data, relevant epidemiological designs, and methods to control for biases. Real world studies are increasingly considered a valuable (and cost effective) contribution to the evidence base and are complementary to randomised controlled trials 14. The authors made extensive efforts to improve data quality to enhance the precision of outcomes by including diagnoses, prescriptions, laboratory tests, and by conducting a review of medical charts for incident case identification.…”