Electronic health records (EHRs) can define real world patient populations with high levels
of clinical specificity, potentially addressing some of the shortcomings of other types of real …

e18098 Background: Single-arm and open-label clinical studies are common in oncology
drug development, leading to a frequent need for contextualization of results and provision …

Real-world data (RWD) from electronic health records (EHRs) and administrative claims
databases are used increasingly to generate real-world evidence (RWE). RWE is used to …

The gold standard in evaluating treatment effects are randomized controlled trials (RCTs).
Their design minimizes bias and maximizes our ability to identify causality. By contrast …

Background Clinical trials are the gold standard for generating robust medical evidence, but
clinical trial results often raise generalizability concerns, which can be attributed to the lack …

Background Comparative‐effectiveness studies using real‐world data (RWD) can be
susceptible to surveillance bias. In solid tumor oncology studies, analyses of endpoints such …

Background Considering the sequence of treatments is vital for optimising healthcare
resource allocation, especially in cancer care, where sequence changes can affect patients' …

Embedded pragmatic clinical trials (ePCTs) are conducted during routine clinical care and
have the potential to increase knowledge about the effectiveness of interventions under real …

The use of data from the real world to address clinical and policy-relevant questions that
cannot be answered using data from clinical trials is garnering increased interest. Indeed …

On April 13, 2022, the US Food and Drug Administration (FDA) released draft guidance with
recommendations regarding the use of a Race and Ethnicity Diversity Plan in clinical trials. 1 …