Randomized controlled trials (RCTs) are regarded as the gold standard of evidence‐based
medicine. However, the disadvantages of RCTs have been well‐documented for a lengthy …

Aim: The aim of this study is to analyze the real-world outcomes of transforaminal epidural
steroid injections (TFESIs) in all patients with radiculopathy and their long-term outcomes …

Highlights•The need for fit-for-purpose oncology RWD is growing in Japan.•NCCHE and
FHKK are partnering to curate oncology RWD in Japan.•Established methods are adapted to …

PURPOSE To apply target trial emulation to explore the potential impact of eligibility criteria
on the primary outcome of a randomized controlled trial. METHODS Simulations of a real …

Objective Low rates of inclusion of real-world evidence (RWE) during regulation may arise
from lack of clarity and consensus on its definition. A conceptually mature definition of RWE …

Before a medicine can be recommended for a marketing authorization research must be
provided to regulators that convincingly supports the benefit‐risk of the product in the …

Background Entheogen use is becoming increasingly popular and a potential option for
treatment or adjuvant treatment for various medical conditions. Clinical studies are needed …

Advanced practice providers (APPs) represent a growing and critical component of the
oncology workforce. By 2017, more than 80% of US oncology practices reported employing …

This chapter provides a brief history of the influence of clinical pharmacology on
modernizing drug regulation and development. The intertwined emergence of …

Background Nefecon, the first innovative drug approved by both the US FDA and European
EMA for IgA nephropathy, lacked comprehensive real-world assessments of its adverse …