title: Molecular Tumor Boards: Ethical Issues in the New Era of Data Medicine.
abstract: The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with "genomic medicine" nor with "precision medicine", but with "data medicine" (DM) (big data, data mining). The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The "transformation" of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a new vision of care. Molecular tumor boards (MTB) are one response to these changes and are now providing better access to next-generation sequencing (NGS) and new cancer treatments to patients with inoperable or metastatic cancers, and those for whom the usual treatment has failed. However, MTB face a crucial ethical challenge: maintaining and improving the trust of patients, clinicians, researchers and industry in academic medical centers supported by private or public funding rather than providing genetic data directly to private companies. We believe that, in this era of DM, appropriate modern digital communication networks will be required to maintain this trust and to improve the organization and effectiveness of the system. There is, therefore, a need to reconsider the form and content of informed consent (IC) documents at all academic medical centers and to introduce dynamic and electronic informed consent (e-IC).
authors.affiliation: Medical Ethics and Legal Medicine Laboratory EA4569, Paris Descartes University, Centre Universitaire des Saints-Pères, Paris, France.|Cancer Research for Personalized Medicine (CARPEM), Paris Descartes, APHP (HEGP, Cochin, Necker) INSERM, Paris, France.
authors.forename: Henri-Corto
authors.initials: HC
authors.lastname: Stoeklé
authors.affiliation: Medical Ethics and Legal Medicine Laboratory EA4569, Paris Descartes University, Centre Universitaire des Saints-Pères, Paris, France.|Cancer Research for Personalized Medicine (CARPEM), Paris Descartes, APHP (HEGP, Cochin, Necker) INSERM, Paris, France.|Assistance Publique-Hôpitaux de Paris AP-HP, Necker-Enfants Malades Hospital, Paris, France.
authors.forename: Marie-France
authors.initials: MF
authors.lastname: Mamzer-Bruneel
authors.affiliation: Medical Ethics and Legal Medicine Laboratory EA4569, Paris Descartes University, Centre Universitaire des Saints-Pères, Paris, France.
authors.forename: Charles-Henry
authors.initials: CH
authors.lastname: Frouart
authors.affiliation: Department of Medical Oncology, Institut Curie, Paris, Saint-Cloud, France.|EA7285, Versailles University, Saint-Quentin-en-Yvelines, Versailles, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Le Tourneau
authors.affiliation: Cancer Research for Personalized Medicine (CARPEM), Paris Descartes, APHP (HEGP, Cochin, Necker) INSERM, Paris, France.|Inserm UMR-S1147, Paris Descartes University, Centre Universitaire des Saints-Pères, Paris, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Laurent-Puig
authors.affiliation: Medical Ethics and Legal Medicine Laboratory EA4569, Paris Descartes University, Centre Universitaire des Saints-Pères, Paris, France. guillaume.vogt@inserm.fr.|Neglected Human Genetics, Centre National de Genotypage (CNG-CEA), Evry, France. guillaume.vogt@inserm.fr.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Vogt
authors.affiliation: Medical Ethics and Legal Medicine Laboratory EA4569, Paris Descartes University, Centre Universitaire des Saints-Pères, Paris, France.|Cancer Research for Personalized Medicine (CARPEM), Paris Descartes, APHP (HEGP, Cochin, Necker) INSERM, Paris, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Hervé
mesh_terms: D000077558:Big Data; D018070:Biological Specimen Banks; D035843:Biomedical Research / Q000941:ethics*; D003132:Commerce; D003142:Communication; D057225:Data Mining; D019992:Databases as Topic; D003695:Delivery of Health Care / Q000941:ethics* / Q000379:methods; D004581:Electronics; D032984:Ethics, Research; D005823:Genetics; D006801:Humans; D009369:Neoplasms / Q000235:genetics / Q000628:therapy*; D057285:Precision Medicine / Q000379:methods*; D035502:Trust; D014495:Universities
keywords: Biobank; Bioinformatic; Data medicine (DM); Database; Dynamic consent; Electronic informed consent (e-IC); Ethical issues; Genomic; Molecular tumor board (MTB); Personalized medicine