title: Recommendations for capture, validation and summarisation of data from studies using RECIST.
abstract: Response Evaluation Criteria in Solid Tumors (RECIST) is commonly used in oncology clinical trials and provides a standard approach for the assessment of treatment. However, data capture, validation and summarisation are complex. This article focuses on managing solid tumour lesion and response assessment data from capture through summarisation. Conventions for capturing lesion data, as well as considerations for data validation and summarisation, are provided. Recommendations are based on a review of data capture forms (including data items and instructions), data validation practices and algorithms for data summarisation across solid tumour studies at a single company. The intent of the authors is to share our experiences at GSK in the spirit of harmonisation by transparently describing our decisions and methods.
authors.affiliation: GlaxoSmithKline, Collegeville, PA 19426-0989, USA. Melanie.a.paules@gsk.com
authors.forename: Melanie
authors.initials: M
authors.lastname: Paules
authors.forename: Michelle
authors.initials: M
authors.lastname: Casey
authors.forename: Grant
authors.initials: G
authors.lastname: Williams
authors.forename: R Suzanne
authors.initials: RS
authors.lastname: Swann
authors.forename: Philip S
authors.initials: PS
authors.lastname: Murphy
authors.forename: Vanessa M
authors.initials: VM
authors.lastname: Salazar
authors.forename: Diane
authors.initials: D
authors.lastname: Foose
authors.forename: Barbara
authors.initials: B
authors.lastname: Bailey
authors.forename: Patrick
authors.initials: P
authors.lastname: Therasse
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003625:Data Collection / Q000379:methods*; D003627:Data Interpretation, Statistical; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D017410:Practice Guidelines as Topic; D016896:Treatment Outcome