Symptomatic adverse events are common with cancer therapies, and provide key information about tolerability during development and regulatory review. After a therapy becomes available on the market, information about these adverse events is essential for patient and clinician decision-making. Historically, the standard approach for collecting symptomatic adverse events in trials depended on clinician reporting via the National Cancer Institute’s (NCI) Common Terminology Criteria for Adverse Events (CTCAE)—but this process was found to be unreliable and to miss about half of patients’ symptoms
There is increasing interest in collecting patient-reported outcomes (PROs) in oncology drug develop...
Understanding the potential profile of adverse events associated with cancer treatment is essential ...
IMPORTANCE: In cancer clinical trials, symptomatic adverse events (AEs), such as nausea, are reporte...
Systematic capture of the patient perspective can inform the development of new cancer therapies. Pa...
The US Food and Drug Administration and the Critical Path Institute's Patient-Reported Outcome (PRO)...
Context: Clinical practice guidelines advocate for routine assessment of symptoms and adverse events...
Patient-reported outcomes (PROs) have historically been used in clinical trials to assess symptoms o...
Immune-related adverse events (IrAEs) associated with the use of immune checkpoint inhibitors (ICIs)...
Background: Immune-related adverse events (IrAEs) associated with the use of immune checkpoint inhib...
Background: The development and rapid uptake of immune checkpoint inhibitors (CPI) has changed the ...
Immunotherapy has transformed the treatment of various cancers by strengthening suppressed immune sy...
IMPORTANCE Standard adverse event (AE) reporting in oncology clinical trials has historically relied...
The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminolo...
Symptomatic toxicities associated with anticancer treatments, such as nausea and vomiting, are frequ...
Immune-checkpoint inhibitors (ICI) have shown significant benefits for overall survival across vario...
There is increasing interest in collecting patient-reported outcomes (PROs) in oncology drug develop...
Understanding the potential profile of adverse events associated with cancer treatment is essential ...
IMPORTANCE: In cancer clinical trials, symptomatic adverse events (AEs), such as nausea, are reporte...
Systematic capture of the patient perspective can inform the development of new cancer therapies. Pa...
The US Food and Drug Administration and the Critical Path Institute's Patient-Reported Outcome (PRO)...
Context: Clinical practice guidelines advocate for routine assessment of symptoms and adverse events...
Patient-reported outcomes (PROs) have historically been used in clinical trials to assess symptoms o...
Immune-related adverse events (IrAEs) associated with the use of immune checkpoint inhibitors (ICIs)...
Background: Immune-related adverse events (IrAEs) associated with the use of immune checkpoint inhib...
Background: The development and rapid uptake of immune checkpoint inhibitors (CPI) has changed the ...
Immunotherapy has transformed the treatment of various cancers by strengthening suppressed immune sy...
IMPORTANCE Standard adverse event (AE) reporting in oncology clinical trials has historically relied...
The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminolo...
Symptomatic toxicities associated with anticancer treatments, such as nausea and vomiting, are frequ...
Immune-checkpoint inhibitors (ICI) have shown significant benefits for overall survival across vario...
There is increasing interest in collecting patient-reported outcomes (PROs) in oncology drug develop...
Understanding the potential profile of adverse events associated with cancer treatment is essential ...
IMPORTANCE: In cancer clinical trials, symptomatic adverse events (AEs), such as nausea, are reporte...