title: Looking to the future in an unprecedented time for cancer drug development.
abstract: Basic research in cancer biology, genetics and immunology has resulted in improved insights into mechanisms that drive tumor initiation and growth. This improved biologic understanding of the diseases we treat has led to unprecedented therapeutic breakthroughs across multiple tumor types. In this article, we discuss opportunities and challenges in contemporary cancer drug development, highlighting efficacy endpoints, clinical trial design and the thoughtful inclusion of the patient perspective. As the field re-examines old practices and explores new opportunities, we must continue to efficiently utilize the human and scientific resources at our disposal to foster the development and delivery of safe and effective therapies to cancer patients.
authors.affiliation: Office of Hematology and Oncology Products, FDA/CDER/OND, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA. Electronic address: Paul.Kluetz@fda.hhs.gov.
authors.forename: Paul G
authors.initials: PG
authors.lastname: Kluetz
authors.affiliation: Office of Hematology and Oncology Products, FDA/CDER/OND, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Pazdur
mesh_terms: D055808:Drug Discovery / Q000639:trends; D023381:Endpoint Determination; D005544:Forecasting; D006801:Humans; D007167:Immunotherapy; D058990:Molecular Targeted Therapy; D009369:Neoplasms / Q000188:drug therapy*; D063868:Patient Outcome Assessment
keywords: Clinical trials; Endpoints; Regulation