OBJECTIVE: Quality assurance (QA) in clinical trials is essential to ensure treatment is safely and effectively delivered. As QA requirements have increased in complexity in parallel with evolution of radiation therapy (RT) delivery, a need to facilitate digital data exchange emerged. Our objective is to present the platform developed for the integration and standardization of QART activities across all EORTC trials involving RT. METHODS: The following essential requirements were identified: secure and easy access without on-site software installation; integration within the existing EORTC clinical remote data capture system; and the ability to both customize the platform to specific studies and adapt to future needs. After retrospective testing within several clinical trials, the platform was introduced in phases to participating sites and QART study reviewers. RESULTS: The resulting QA platform, integrating RT analysis software installed at EORTC Headquarters, permits timely, secure, and fully digital central DICOM-RT based data review. Participating sites submit data through a standard secure upload webpage. Supplemental information is submitted in parallel through web-based forms. An internal quality check by the QART office verifies data consistency, formatting, and anonymization. QART reviewers have remote access through a terminal server. Reviewers evaluate submissions for protocol compliance through an online evaluation matrix. Comments are collected by the coordinating centre and institutions are informed of the results. CONCLUSIONS: This web-based central review platform facilitates rapid, extensive, and prospective QART review. This reduces the risk that trial outcomes are compromised through inadequate radiotherapy and facilitates correlation of results with clinical outcomes.
OBJECTIVE: Quality assurance (QA) in clinical trials is essential to ensure treatment is safely and effectively delivered. As QA requirements have increased in complexity in parallel with evolution of radiation therapy (RT) delivery, a need to facilitate digital data exchange emerged. Our objective is to present the platform developed for the integration and standardization of QART activities across all EORTC trials involving RT. METHODS: The following essential requirements were identified: secure and easy access without on-site software installation; integration within the existing EORTC clinical remote data capture system; and the ability to both customize the platform to specific studies and adapt to future needs. After retrospective testing within several clinical trials, the platform was introduced in phases to participating sites and QART study reviewers. RESULTS: The resulting QA platform, integrating RT analysis software installed at EORTC Headquarters, permits timely, secure, and fully digital central DICOM-RT based data review. Participating sites submit data through a standard secure upload webpage. Supplemental information is submitted in parallel through web-based forms. An internal quality check by the QART office verifies data consistency, formatting, and anonymization. QART reviewers have remote access through a terminal server. Reviewers evaluate submissions for protocol compliance through an online evaluation matrix. Comments are collected by the coordinating centre and institutions are informed of the results. CONCLUSIONS: This web-based central review platform facilitates rapid, extensive, and prospective QART review. This reduces the risk that trial outcomes are compromised through inadequate radiotherapy and facilitates correlation of results with clinical outcomes.
Authors: S Adebahr; S Collette; E Shash; M Lambrecht; C Le Pechoux; C Faivre-Finn; D De Ruysscher; H Peulen; J Belderbos; R Dziadziuszko; C Fink; M Guckenberger; C Hurkmans; U Nestle Journal: Br J Radiol Date: 2015-04-15 Impact factor: 3.039
Authors: Erik Roelofs; Lucas Persoon; Sebastiaan Nijsten; Wolfgang Wiessler; André Dekker; Philippe Lambin Journal: Radiother Oncol Date: 2013-02-05 Impact factor: 6.280
Authors: André N Abrunhosa-Branquinho; Raquel Bar-Deroma; Sandra Collette; Enrico Clementel; Yan Liu; Coen W Hurkmans; Loïc Feuvret; Karen Van Beek; Martin van den Bent; Brigitta G Baumert; Damien C Weber Journal: Radiother Oncol Date: 2018-03-29 Impact factor: 6.280
Authors: Christopher G Willett; Jennifer Moughan; Elizabeth O'Meara; James M Galvin; Christopher H Crane; Kathryn Winter; Denise Manfredi; Tyvin A Rich; Rachel Rabinovitch; Robert Lustig; Mitchell Machtay; Walter J Curran Journal: Radiother Oncol Date: 2012-10-17 Impact factor: 6.280