Incorporating Patient-Reported Outcomes Into Early-Phase Trials

Chen, Alice; Mitchell, Sandra A.; Minasian, Lori M.; Germain, Diane C. St.

doi:10.1016/b978-0-12-812512-0.00013-0

Cited by 5 publications

(3 citation statements)

References 63 publications

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“…CTCAE includes a severity grading scale ( Table 1 ) 8 such that the report of any AE item always has a severity grade. This severity grading is used to report a safety signal requiring medical intervention to prevent a life-threatening event from happening.…”

Section: Ctcae: Clinician Terminology For Reportingmentioning

confidence: 99%

“…41 The choice of items should be informed by the anticipated adverse events based on previous preclinical data and regimen-specific information about the anticipated profile of symptomatic adverse events drawn from the Comprehensive Adverse Events and Potential Risks List (CAEPR). 8 In a randomized trial with different agents and regimens, all participants should report on the same AE items across the different trial arms to reduce reporting bias. For example, if one arm of the trial includes agents for which the common AE is diarrhea and the other arm includes agents for which the common AE is a rash, all trial participants should report on both diarrhea and rash.…”

mentioning

confidence: 99%

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Clinician and Patient Reporting of Symptomatic Adverse Events in Cancer Clinical Trials: Using CTCAE and PRO-CTCAE® to Provide Two Distinct and Complementary Perspectives

Minasian¹,

O’Mara²,

Mitchell³

2022

PROM

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Inclusion of the patient perspective in the reporting of symptomatic adverse events provides different and complementary information to clinician reporting using the Common Terminology Criteria for Adverse Events (CTCAE). The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE ® ) is designed for patients to self-report their symptomatic adverse events in a manner that complements CTCAE reporting. Using CTCAE and PRO-CTCAE together offers the potential to refine our understanding of the prevalence and trajectory of lower grade AEs that can lead to elective discontinuation of therapy and diminished quality of life. This review addresses the development of PRO-CTCAE with an emphasis on the differences between PRO-CTCAE scores and CTCAE severity grades. This distinction is important when evaluating, grading and reporting toxicity and tolerability in cancer clinical trials.

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Section: Ctcae: Clinician Terminology For Reportingmentioning

confidence: 99%

mentioning

confidence: 99%

Clinician and Patient Reporting of Symptomatic Adverse Events in Cancer Clinical Trials: Using CTCAE and PRO-CTCAE® to Provide Two Distinct and Complementary Perspectives

Minasian¹,

O’Mara²,

Mitchell³

2022

PROM

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“…Radiopharmaceuticals fit well into the programmatic mission of patient safety and symptom management for NCI sponsored clinical trials. Thus, integrating pilot HRQOL tools into early phase safety trials that are eventually intended to be used in late phase efficacy trials makes sense (3). Wearable digital technology in the form of mobile phone applications or wristband sensors captures in near-time the HRQOL and PRO data linked to acute toxicity, prompt and iterative symptom management, as well as reasons for treatment-related drug holiday or drug discontinuation (4).…”

Section: Introductionmentioning

confidence: 99%

Clinical Outcome Assessments Toolbox for Radiopharmaceuticals

et al. 2019

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For nearly 40 years, the U.S. National Cancer Institute (NCI) has funded health-related quality-of-life (HRQOL) and symptom management in oncology clinical trials as a method for including a cancer patient's experience during and after treatment. The NCI's planned scope for HRQOL, symptom and patient-reported outcomes management research is explained as it pertains to radiopharmaceutical clinical development. An effort already underway to support protocol authoring via an NCI Cancer Therapy Evaluation Program (CTEP) Centralized Protocol Writing Service (CPWS) is described as this service aids incorporation of HRQOL, symptom and patient-reported outcomes management research into sponsored protocols.

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