How to Overcome Challenges When Backing Regulatory Submissions with Real-World Data

May 5, 2023

blue digital binary data on computer screen. Close-up shallow DOF

Clinical developers and regulatory approval agencies are increasingly relying on real-world data (RWD) and the real-world evidence (RWE) generated from it in decision-making. However, clinical research organizations (CROs) often run into significant pitfalls when using RWD, complicating the process and driving up expenses. In a new Applied Clinical Trials article, learn what these challenges are and how to overcome them.

According to Jessica Johnson and Mark Lambrecht, “A common mistake when seeking to leverage RWE to support or demonstrate a product’s safety and efficacy is failing to share a prespecified protocol and statistical analysis plan or SAP with the specified regulatory agency. Taking a proactive approach and aligning with FDA’s RWE framework recommendations can help guard against this risk. This includes ensuring that multiple analyses in electronic data sets are carried out quickly and inexpensively, making it possible to conduct numerous retrospective studies until the desired result is obtained.”

To read more, click here.