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Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections.

Autor: Kim J; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland. Janice.Kim@fda.hhs.gov., Singh H; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Ayalew K; Office of Scientific Investigations, Office of Compliance, CDER, U.S. Food and Drug Administration, Silver Spring, Maryland., Borror K; Office for Human Research Protections, U.S. Department of Health and Human Services (HHS), Washington, DC., Campbell M; Clinical Outcomes Assessment Staff, Office of New Drugs, CDER, U.S. Food and Drug Administration, Silver Spring, Maryland., Johnson LL; Office of Biostatistics, CDER, U.S. Food and Drug Administration, Silver Spring, Maryland., Karesh A; Office of Medical Policy, CDER, U.S. Food and Drug Administration, Silver Spring, Maryland., Khin NA; Office of Scientific Investigations, Office of Compliance, CDER, U.S. Food and Drug Administration, Silver Spring, Maryland., Less JR; Office of Good Clinical Practice, Office of Medical Products and Tobacco, U.S. Food and Drug Administration, Silver Spring, Maryland., Menikoff J; Office for Human Research Protections, U.S. Department of Health and Human Services (HHS), Washington, DC., Minasian L; National Cancer Institute, National Institutes of Health, U.S. Department of Health and Human Services, Washington, DC., Mitchell SA; National Cancer Institute, National Institutes of Health, U.S. Department of Health and Human Services, Washington, DC., Papadopoulos EJ; Clinical Outcomes Assessment Staff, Office of New Drugs, CDER, U.S. Food and Drug Administration, Silver Spring, Maryland., Piekarz RL; National Cancer Institute, National Institutes of Health, U.S. Department of Health and Human Services, Washington, DC., Prohaska KA; Office of Good Clinical Practice, Office of Medical Products and Tobacco, U.S. Food and Drug Administration, Silver Spring, Maryland., Thompson S; Office of Scientific Investigations, Office of Compliance, CDER, U.S. Food and Drug Administration, Silver Spring, Maryland., Sridhara R; Office of Biostatistics, CDER, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Kluetz PG; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2018 Apr 15; Vol. 24 (8), pp. 1780-1784. Date of Electronic Publication: 2017 Dec 13.

Combined Exogenous Activation of Bovine Oocytes: Effects on Maturation-Promoting Factor, Mitogen-Activated Protein Kinases, and Embryonic Competence.

Autor: Valencia, Cecilia¹ (AUTHOR) luis.aguila@ufrontera.cl, Pérez-García, Felipe¹ (AUTHOR) ricardo.felmer@ufrontera.cl, Aguila, Luis¹ (AUTHOR), Felmer, Ricardo^1,2 (AUTHOR), Arias, María Elena^1,3 (AUTHOR) mariaelena.arias@ufrontera.cl

Publikováno v: International Journal of Molecular Sciences. Nov2023, Vol. 24 Issue 21, p15794. 17p.

International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials.

Autor: Brady, Keri J. S.¹ (AUTHOR), Peipert, John Devin² (AUTHOR), Atkinson, Thomas M.³ (AUTHOR), Pompili, Cecilia⁴ (AUTHOR), Pinto, Monica⁵ (AUTHOR), Shaw, James W.⁶ (AUTHOR), Roydhouse, Jessica⁷ (AUTHOR) jessica.roydhouse@utas.edu.au

Publikováno v: Quality of Life Research. Aug2023, Vol. 32 Issue 8, p2155-2163. 9p.

A review of OHRP compliance oversight letters.

Autor: Borror K; Division of Compliance Oversight, Office for Human Research Protections, Department of Health and Human Services, USA., Carome M, McNeilly P, Weil C

Publikováno v: IRB [IRB] 2003 Sep-Oct; Vol. 25 (5), pp. 1-4.