A reproducible framework for monitoring the impact of randomized clinical trials on clinical practice using large-scale real-world data: application to gynaecological surgical trials using the French national healthcare database.

ABSTRACT:

Background

Randomized clinical trials (RCTs) are fundamental to evidence-based medicine, but their real-world impact on clinical practice often remains unmonitored. Leveraging large-scale real-world data can enable systematic monitoring of RCT effects. We aimed to develop a reproducible framework using real-world data to assess how major RCTs influence medical practice, using two pivotal surgical RCTs in gynaecologic oncology as an example-the LACC (Laparoscopic Approach to Cervical Cancer) and LION (Lymphadenectomy in Ovarian Neoplasms) trials.

Methods

We utilized data from the French National Health Insurance Database (SNDS), covering 98.8% of France's population. We analysed patients who underwent radical hysterectomy for cervical cancer (2013-2022) and patients who under

SUBMITTER: Jochum F 

PROVIDER: S-EPMC11764352 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature