Patient|Reported Outcomes in Early Phase Clinical Trials

The value of patient-reported outcomes in early-phase clinical trials

If used correctly, patient-reported outcomes can provide preliminary evidence of efficacy and tolerability from a patient perspective, ...

Patient-Reported Outcomes in Early Phase Clinical Trials - NCBI

This commentary highlights the potential relevance of including patient-reported outcomes in early phase trials and the barriers to such inclusion.

The value of patient-reported outcomes in early-phase clinical trials

The value of patient-reported outcomes in early-phase clinical trials.

Patient-Reported Outcomes in Early Phase Clinical Trials

PROs provide insight into patients' perceptions of treatment, possible side effects, and impact on their quality of life.

Amplifying the Patient's Voice in Oncology Early-Phase Clinical Trials

Involving patients and advocates and incorporating patient-reported outcomes (PROs) throughout the process, from initial DFOT design, through ...

integrating patient reported outcomes for tolerability assessment in ...

Early phase clinical trials provide an initial evaluation of therapies' risks and benefits to patients, including safety and tolerability, which typically ...

Assessment of Patient-Reported Outcomes in Industry-Sponsored ...

Patient-reported outcomes (PROs) are rarely assessed in phase I oncology studies, although recent initiatives from Food and Drug Administration encourage their ...

Patient-Reported Outcomes in Early Phase Trials for Patients with ...

Assessing symptomatic toxicities associated with new therapies in early phase trials from the patient perspective is best measured using patient ...

Statistical methods and data visualisation of patient-reported ...

The introduction of patient-reported outcomes (PROs), where the patient can assess their own symptomatic adverse events or quality of life, has ...

The Use of Patient-Reported Outcome Measures in Phase I ...

Conclusion: Although uncommon in phase I oncology clinical trials, PRO usage is increasing over time. PRO measures were often unspecified on ...

Patient-Reported Outcomes in Cancer Clinical Trials

Capturing a patient's self-report using well-validated measures offers a direct indicator of change in symptoms, function, or well-being during treatment, ...

A tailored phase I-specific patient-reported outcome (PRO) survey to ...

Patient perspectives are fundamental to defining tolerability of investigational anti-neoplastic therapies in clinical trials. Phase I ...

Application of Patient-Reported Outcome Measurements in Clinical ...

This cross-sectional study evaluates the use of patient-reported outcome instruments as primary and secondary outcomes in randomized ...

Office of Patient-Centered Outcomes Research

Such patient-focused approaches use clinical outcomes assessments (COAs), in which information is gathered on the impact of treatment on the person and can ...

Trends in patient‐reported outcome use in early phase dose‐finding ...

Study and PRO characteristics were extracted. Completed trials that reported PRO outcomes and published manuscripts on ClinicalTrials.gov were ...

Patient-Reported Outcomes in Phase 3 Clinical Trials for Blood ...

Of the 66 trials that included PROs as an end point, 26 (39%) reported these data in the primary trial publication. Of these, 8 (31%) reported ...

[PDF] Patient-Reported Outcomes in Early Phase Clinical Trials

This commentary highlights the potential relevance of including patient-reported outcomes in early phase trials and the barriers to such inclusion.

(PDF) Patient-Reported Outcomes in Early Phase Clinical Trials

PDF | This commentary highlights the potential relevance of including patient-reported outcomes in early phase trials and the barriers to ...

Patient-Reported Outcomes for Tolerability Assessment in Phase I ...

Patient-reported outcomes (PROs) have historically been used in clinical trials to assess symptoms or quality of life in pivotal (late phase) or postmarket.

Patient and public involvement and engagement in the development ...

There is growing interest in the introduction of patient-reported outcomes (PROs) within dose-finding trials. PROs are reports of a patient's ...