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The Potential to Leverage Real-World Data for Pediatric Clinical Trials: A Proof-of-Concept Study

The Potential to Leverage Real-World Data for Pediatric Clinical Trials: A Proof-of-Concept Study

Each list was initially kept separate, and in each case, 3 clinicians and 2 patients were asked to independently review the data element inventory to mark the ones that they believed would be most relevant to be collected during clinical encounters or would be used for an RWD study. In practice, the experts largely agreed with each other and deprioritized very few data items. In retrospect, it is likely that this review step could have been avoided. The inventories were then combined and deduplicated.

Jens Declerck, Joanne Lee, Anando Sen, Avril Palmeri, Rianne Oostenbrink, Viviana Giannuzzi, Simon Woodworth, Salma Malik, Fenna Mahler, Beate Aurich, Rebecca Leary, Dipak Kalra, Volker Straub

J Med Internet Res 2025;27:e72573