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Search Results

Showing results 1 to 20 of 82.

Article

Health-related quality of life with bemarituzumab plus mFOLFOX6 in patients with FGFR2b-overexpressing, advanced gastric or gastroesophageal junction cancer

December 01, 2024
Article

Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials - insights from an expert virtual roundtable

October 01, 2024
Article

Critical comments by Food and Drug Administration reviewers on patient-reported outcomes in Food and Drug Administration regulatory submissions (2018-2021)

June 01, 2024
Article

The limitations of EQ-5D as a clinical outcome assessment tool

May 01, 2024
Article

Patient-reported outcome (PRO) data in oncology NDAs approved by the FDA (2018–2021): A review of criticism and concerns in comments from regulators

April 05, 2024
Article

Recommendations to address respondent burden associated with patient-reported outcome assessment

March 01, 2024
Article

Assessment of patient-reported outcomes in industry-sponsored phase I oncology studies: Considerations for translating theory into practice

October 01, 2023
Article

A review of labeling based on patient-reported outcome endpoints for new oncology drugs approved by the European medicines agency (2017-2021)

June 01, 2023
Article

Trends in the Inclusion of patient reported outcomes in oncology clinical trials: Analysis of clinicaltrials.gov (2013-2022)

June 01, 2023
Article

A review of patient-reported outcome considerations in oncologic drugs advisory committee meetings (2016-2021)

May 01, 2023
Article

Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet-Biedl syndrome: Phase 3 trial results

January 16, 2023
Article

FDA guidance on selecting, developing, or modifying fit-for-purpose clinical outcome assessments: Old wine in a new bottle?

January 01, 2023
Article

Patient experiences with patient-reported outcome measures in metastatic breast cancer trials: qualitative interviews

December 01, 2022
Article

ABCL-310 Health-related quality of life and tolerability in patients with/without skin toxicity during loncastuximab tesirine treatment in a phase 2 clinical trial (LOTIS-2)

October 01, 2022
Article

A review of patient-reported outcome assessments in registration trials of FDA-approved new oncology drugs (2014-2018)

September 01, 2022
Article

Ethical considerations for the inclusion of patient-reported outcomes in clinical research: The PRO ethics guidelines

May 17, 2022
Article

A review of patient-reported outcome labeling of FDA-approved new drugs (2016-2020): Counts, categories, and comprehensibility

April 01, 2022
Article

Health-related quality of life, symptoms, and tolerability of loncastuximab tesirine in patients with relapsed or refractory diffuse large B-cell lymphoma

March 01, 2022
Article

Quality of life outcomes in two phase 3 trials of setmelanotide in patients with obesity due to LEPR or POMC deficiency

February 05, 2022
Article

FDA guidance on assessment of patient-reported outcomes in cancer trials: A breath of fresh air or a storm in a teacup?

November 01, 2021