Centralized Investigator Review of Radiological and Functional Imaging Reports in Real‐World Oncology Studies: The SACHA‐France Experience
Year: 2024
Type: article
Study design: Observational Study
Abstract: SACHA-France (NCT04477681) is a prospective real-world study that collects clinical safety and efficacy data of novel anticancer therapies prescribed off-label or on compassionate use to patients <25 years. From March 2020 until February 2024, 640 patients with solid tumors or lymphomas were included, with 176 (28%) reported objective tumor responses. Centralized medical monitoring of local radiological/functional imaging reports by the SACHA coordinating investigator led to response modification in 45 out of 176 cases (26%), highlighting the relevance of the medical review of study data. We suggest this pragmatic approach for improving clinical trial data when centralized radiological review is not performed.
Source: Pediatric Blood & Cancer
DOI: 10.1002/pbc.31449
Authors: Pablo Berlanga, Isabelle Aerts, Nadège Corradini, Lee Aymar Ndounga‐Diakou, Natacha Entz‐Werle, Stéphane Ducassou, Nicolas André, François Sevrin, Pascal Chastagner, Chloe Puiseux, Morgane Cleirec, Dominique Plantaz, Emilie De Carli, Marion Gambart, Camille Khanfar, Sandrine Thouvenin, Arnaud Petit, Sébastien Klein, Claire Briandet, Frédéric Millot, Claire Pluchart, Yves Reguerre, Pascale Schneider, Jill Serre, Carine Halfon‐Domenech, Liana Carausu, Christophe Piguet, Laure Saumet, Joy Benadiba, Samuel Abbou, Salim Laghouati, Birgit Geoerger, Gilles Vassal
Institutions: Université Paris-Saclay, Institut Gustave Roussy, Inserm, Université Paris Sciences et Lettres, Institut Curie, Centre Léon Bérard, Hôpitaux Universitaires de Strasbourg, Centre Hospitalier Universitaire de Bordeaux, Centre National de la Recherche Scientifique, Aix-Marseille Université, Centre de Recherche en Cancérologie de Marseille, Hôpital de la Timone, Centre Oscar Lambret, Centre Hospitalier Universitaire de Rennes, Centre Hospitalier Universitaire de Nantes, Centre Hospitalier Universitaire de Grenoble, Université Grenoble Alpes, Centre Hospitalier Universitaire d'Angers, Université d'Angers, Centre Hospitalier Universitaire de Toulouse, Centre Hospitalier Universitaire Amiens-Picardie, Centre Hospitalier Universitaire de Saint-Étienne, Hôpital Armand-Trousseau, Centre Hospitalier Universitaire de Besançon, CHU Dijon Bourgogne, Centre Hospitalier Universitaire de Poitiers, Centre Hospitalier Universitaire de Reims, Centre Hospitalier Universitaire de La Réunion, Centre Hospitalier Universitaire de Rouen, Centre Hospitalier Universitaire de Tours, Hospices Civils de Lyon, Centre Hospitalier Régional Universitaire de Brest, Centre Hospitalier Universitaire de Limoges, Centre Hospitalier Universitaire de Montpellier, Centre Hospitalier Universitaire de Nice
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,550
OpenAlex ID: W4404506537