Emulation of randomized clinical trials with nonrandomized database analyses

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The whole findings of the RCT-DUPLICATE demonstration venture are revealed as we speak in JAMA.

This three-year initiative examined whether or not researchers asking medical questions in real-world information (RWD)—information from sufferers’ day-to-day interactions with the well being care system—would receive comparable outcomes to findings from randomized medical trials (RCTs). In circumstances the place medical trial designs aligned with actual affected person care processes, the RWE research and RCTs got here to largely comparable conclusions.

As a part of the RCT-DUPLICATE initiative, researchers created and revealed protocols for observational, real-world analogs to thirty accomplished and two ongoing RCTs, emulating every trial’s design as intently as potential.

They then applied the research principally utilizing the Aetion Proof Platform (AEP), which analyzes information from the true world to provide clear, speedy, and scientifically validated solutions on the protection, effectiveness, and worth of medical therapies.

The outcomes present that in about half of the circumstances the place researchers have been in a position to intently mimic the design of the corresponding RCT utilizing RWD, the RWE research got here to an analogous conclusion because the analogous RCT. In lots of circumstances the place RWE and RCTs didn’t come to an analogous conclusion, the RCT design itself didn’t align with real-world medical apply, making a problem for emulation of the trial utilizing RWD. In these situations, RWE and RCTs might each be reaching significant conclusions, however to subtly completely different analysis questions.

“The RCT-DUPLICATE initiative additional demonstrates that RWE has the potential to reinforce findings from RCTs and guides us to circumstances the place RWE and RCTs could also be anticipated to succeed in comparable conclusions,” mentioned Nicolle Gatto, Ph.D., M.P.H., Chief Science Officer at Aetion.

“This work is essential in selling and understanding the worth of RWE for decision-making as we proceed to evaluate RWE’s makes use of, advantages, and limitations.”

Extra data:
Shirley V. Wang et al, Emulation of Randomized Medical Trials With Nonrandomized Database Analyses, JAMA (2023). DOI: 10.1001/jama.2023.4221

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