Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada

Author:

Kluetz Paul G,O'Connor Daniel J,Soltys Katherine

Publisher

Elsevier BV

Subject

Oncology

Reference42 articles.

1. Toward patient-centered drug development in oncology;Basch;N Engl J Med,2013

2. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labelling claims,2009

3. Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man. The use of patient-reported outcome (PRO) measures in oncology studies,2016

4. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE);Basch;J Natl Cancer Inst,2014

5. Validity and reliability of the US National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE);Dueck;JAMA Oncol,2015

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