Resources
We have compiled some resources that can be helpful to researchers seeking to include PROs into their work.
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
A patient-reported outcome measurement system developed by the National Cancer Institute to capture symptomatic adverse events in patients on cancer clinical trials.
Patient-Reported Outcomes Measurement Information System (PROMIS)
The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH-funded initiative to develop and validate patient-reported outcomes (PROs) for clinical research and practice. It is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions.
Additional Links
FDA Oncology Center of Excellence
FDA Center for Drug Evaluation and Research (CDER)
Publications
Clinical trial challenges, design considerations, and outcome measures in rare CNS tumors
Terri S. Armstrong, Mark R. Gilbert
Neuro-Oncology, Volume 23, Issue Supplement_5, November 2021, Pages S30–S38.
Phase I study of Zotiraciclib in combination with Temozolomide for patients with recurrent high-grade astrocytomas
Wu, J., Yuan, Y., Long Priel, D.A. et al
Clinical Cancer Research, 2021,27(12): 3298-4730.
A prospective phase II randomized trial of proton radiotherapy vs intensity-modulated radiotherapy for patients with newly diagnosed glioblastoma
Paul D. Brown., Caroline Chung, Diane D. Liu, Sarah McAvoy, David Grosshans, Karine Al Feghali, Anita Mahajan, Jing Li, Susan L. McGovern, Mary-Fran McAleer, Amol J. Ghia, Erik P. Sulman, Marta Penas-Prado, John F. de Groot, Amy B. Heimberger, Jihong Wang, Terri S. Armstrong, Mark R. Gilbert, Nandita Guha-Thakurta, and Jeffrey S. Wefel
23(8), 1337–1347, 2021 | doi:10.1093/neuonc/noab040 | Advance Access date 27 February 2021.
A Phase II Study of Dose-Dense Temozolomide and Lapatinib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial, and Spinal Cord Ependymoma
Gilbert, MR., Yuan, Y., Wu, J., Mendoza, T., Vera, E., Omuro, A., Lieberman, F., Robins, HI., Gerstner, ER., Wu, J., Wen, PY., Mikkelsen, T., Aldape, K., Armstrong TS
Neuro Oncol. 2020 Oct 21:noaa240. doi: 10.1093/neuonc/noaa240.
Glioma patient reported outcome assessment in clinical care and research: a RANO collaborative report
Armstrong, T.S., Dirven, L., Arons, D., Bates, A., Chang, S.M., Coens, C., Espinasse, C., Gilbert, M.R., Jenkinson, D., Kluetz, P., Mendoza, T., Rubinstein, L., Sul, J., Weller, M., Wen, P.Y., Van den Bent, M.J., & Taphoorn, M.
Lancet Oncology, 2020, 21(2), e97-e103.