Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop

Author:

Kluetz Paul G.,Kanapuru Bindu,Lemery Steven,Johnson Laura Lee,Fiero Mallorie H.,Arscott Karen,Barbachano Yolanda,Basch Ethan,Campbell Michelle,Cappelleri Joseph C.,Cella David,Cleeland Charles,Coens Corneel,Daniels Selena,Denlinger Crystal S.,Fairclough Dianne L.,Hillard James R.,Minasian Lori,Mitchell Sandra A.,O’Connor Daniel,Patel Sheetal,Rubin Eric H.,Ryden Anna,Soltys Katherine,Sridhara Rajeshwari,Thanarajasingam Gita,Velikova Galina,Coons Stephen Joel

Publisher

Elsevier BV

Subject

Public Health, Environmental and Occupational Health,Health Policy

Reference17 articles.

1. U.S. Food and Drug Administration. FDA Oncology Center of Excellence Patient Focused Drug Development Program. 2017. Available from: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm544143.htm. [Accessed July 30, 2017].

2. Focusing on core patient-reported outcomes in cancer clinical trials: symptomatic adverse events, physical function, and disease-related symptoms;Kluetz;Clin Cancer Res,2016

3. Focusing on core patient-reported outcomes in cancer clinical trials-response;Kluetz;Clin Cancer Res,2016

4. The imperative for a new approach to toxicity analysis in oncology clinical trials;Thanarajasingam;J Natl Cancer Inst,2015

5. Critcal Path Institute. Critical Path Institute PRO Consortium: past workshops. 2017. Available from: https://c-path.org/programs/pro/#section-2756. [Accessed July 30, 2017].

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