Compared with drugs from the blockbuster era, recently authorized drugs and those
expected in the future present a heterogenous mix of chemicals, biologicals, and cell and …

Globally, cancer is the second leading cause of death, with numbers greatly exceeding
those for human immunodeficiency virus/acquired immunodeficiency syndrome …

Historical controls (HCs) can be used for model parameter estimation at the study design
phase, adaptation within a study, or supplementation or replacement of a control arm …

Randomized controlled trials are the gold standard to investigate efficacy and safety of new
treatments. In certain settings, however, randomizing patients to control may be difficult for …

Judicious use of real‐world data (RWD) is expected to make all steps in the development
and use of pharmaceuticals more effective and efficient, including research and …

The goal of clinical trial research is to deliver safe and efficacious new treatments to patients
in need in a timely and cost-effective manner. There is precedent in using historical control …

With more and better clinical data being captured outside of clinical studies and greater data
sharing of clinical studies, external controls may become a more attractive alternative to …

Objectives Non-randomised clinical trial designs involving comparisons against external
controls or specific standards can be used to support regulatory submissions for indications …

Real‐world data and patient‐level data from completed randomized controlled trials are
becoming available for secondary analysis on an unprecedented scale. A range of novel …

Oncology drug development increasingly relies on single‐arm clinical trials. External
controls (EC s) derived from electronic health record (EHR) databases may provide …