title: Clinical Trial Design in Neuroendocrine Tumors.
abstract: Neuroendocrine tumors (NETs) present tremendous opportunities for productive clinical investigation, but substantial challenges as well. Investigators must be aware of common pitfalls in study design, informed by an understanding of the history of trials in the field, to make the best use of available data and our patient volunteers. We believe the salient issues in clinical trial design and interpretation in the NET field are patient homogeneity, standardized response assessment, and rigorous design and execution. Whether designing or interpreting a study in patients with NET, these principles should drive assessment.
authors.affiliation: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Unit 426, 1515 Holcombe Boulevard, Houston, TX 77030, USA.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Halperin
authors.affiliation: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Unit 426, 1515 Holcombe Boulevard, Houston, TX 77030, USA. Electronic address: jyao@mdanderson.org.
authors.forename: James C
authors.initials: JC
authors.lastname: Yao
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D018572:Disease-Free Survival; D006801:Humans; D018358:Neuroendocrine Tumors / Q000628:therapy*; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000706:statistics & numerical data; D018579:Patient Selection; D011788:Quality of Life; D012107:Research Design
keywords: Clinical trials; Neuroendocrine tumors; Patient homogeneity; Standardized response assessment; Study design and interpretation