Background With the growing notion of patient-focused drug development, the quality of life
and other patient-reported outcomes (PROs) of cancer patients are gaining considerable …

Importance Published research suggests that patient-reported outcomes (PROs) are neither
commonly collected nor reported in randomized clinical trials (RCTs) for solid tumors. Little …

Importance The US Food and Drug Administration's (FDA) accelerated approval pathway
allows approval of investigational drugs treating unmet medical needs based on changes to …

Major associations of medical oncologists remark that novel anticancer treatments should
guarantee improvement of survival outcomes as well as of patients' quality of life (QoL) …

Background In addition to improving survival outcomes, new oncology treatments should
lead to amelioration of patients' quality of life (QoL). Herein, we examined whether QoL …

The ethical permissibility of randomized controlled trials (RCTs) depends on clinical
equipoise at the time of trial enrollment—the existence of uncertainty about which treatment …

Background Umbrella clinical trials in precision oncology are designed to tailor therapies to
the specific genetic changes within a tumor. Little is known about the risk/benefit ratio for …

Drug development is paramount to improve outcomes in patients with gynecologic cancers.
A randomized clinical trial should measure whether a clinically relevant improvement is …

Surrogate endpoints for HTA decisions of breast cancer drugs... : Current Opinion in Oncology
Surrogate endpoints for HTA decisions of breast cancer drugs: utility and pitfalls : Current …

Patients with cancer expect prolonged life (overall survival, OS) or better life (quality of life,
QOL) from cancer treatments. However, majority of new cancer drugs are now being …