Mobile Apps and Real World Evidence

The randomised clinical trial (RCT) has long been the gold standard in drug development but this tightly controlled environment provides a poor picture of how a new therapy will fare in the real world. So-called real-world evidence (RWE) may not be as effective as RCTs in collecting efficacy data, but the large number of patients involved can provide a better way of monitoring safety across the treated patient population for pharmacovigilance and risk management purposes.

Validated mobile apps, such as AE Reporter, and wearable technologies are now an integral part of the real world and offer the potential to enhance data collection from large groups of patients that in turn could lead to improvements in pharmacovigilance and risk management.

Posted in Apps, Patient Safety, Software Development, Technology, Validation