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Une Version Provisoire Initiale De Ce Livre Blanc a Été Préparée Pour La Réunion Du 28 Janvier. Elle a Été Révisée De M Une version provisoire initiale de ce Livre blanc a été préparée pour la réunion du 28 janvier. Elle a été révisée de manière substantielle depuis cette date, suite à des discussions pendant et après la réunion. La liste des contributeurs et des participants se trouve à la fin de ce document. 1 Sommaire Introduction................................................................................................................3 Chapitre 1. Présentation du contexte ......................................................................4 Pourquoi maintenant ? ..........................................................................................5 Impact potentiel sur la santé humaine.................................................................7 Encadré 1. Répondre aux besoins de l’écosystème biomédical dans son ensemble .............................................................................................................8 Recruter des parties prenantes ............................................................................9 Recruter des parties prenantes : attitudes du public envers le partage des données................................................................................................................9 Recruter des parties prenantes : prestataires de soins de santé .......................11 Recruter des parties prenantes : secteur industriel............................................12 Recruter des parties prenantes : définition de normes.......................................12 Une voie à suivre..................................................................................................13 Chapitre 2. Réglementation, déontologie et technologie ....................................15 Aspects réglementaires et déontologiques.......................................................16 Aspects techniques .............................................................................................21 Encadré 2. Pourquoi envisager l'informatique dématérialisée ? ........................22 Encadré 3. Efforts expérimentaux ......................................................................26 Chapitre 3. Prochaines étapes ...............................................................................27 Lancement de la Global Alliance ........................................................................28 Encadré 4. Incitations au partage.......................................................................31 Ébauche de déclaration de mission, objectifs et principes fondamentaux ...32 Participants, contributeurs et remerciements ......................................................33 Bibliographie............................................................................................................36 2 Introduction Le coût du séquençage du génome a été divisé par un million au cours de ces dernières années, ce qui a conduit à une profusion d’informations sur la base génétique de la santé et des maladies humaines. Cette richesse d’informations génomiques devrait en principe accélérer les progrès en biomédecine – en permettant d’intégrer les informations génomiques et cliniques afin d’identifier la base génétique du cancer, des maladies héréditaires, des maladies infectieuses et des réponses aux médicaments. En-delà de la recherche, l’interprétation de séquences individuelles de génome en pratique clinique serait transformée par la généralisation de la comparaison d’un génome à une collection de séquences et de données cliniques regroupées. Nous ne sommes toutefois pas organisés dans la pratique pour saisir cette extraordinaire opportunité, et nous ne prenons pas non plus le chemin pour y parvenir. Les données sont essentiellement recueillies et étudiées de manière cloisonnée : par maladie, par établissement et par pays. Les procédures réglementaires en vigueur ne pouvaient pas et n’ont pas anticipé les développements technologiques et l’utilité du regroupement des données. Les outils et les méthodes d’analyse ne sont pas standardisés et ils sont incompatibles. Si nous poursuivons sur la voie actuelle, nous obtiendrons probablement un mélange confus de systèmes balkanisés – à l’exemple de ce qui a été développé aux États-Unis pour les dossiers médicaux électroniques – un système qui empêche l’apprentissage à partir des données accumulées en pratique clinique. Le 28 janvier 2013, cinquante collègues venant de huit pays différents se sont rencontrés pour discuter de cette opportunité et de cette difficulté, et pour examiner les moyens de collaboration à mettre en œuvre pour créer des conditions favorisant l’apprentissage et une médecine génomique prospère. Inspirés par l’exemple d’Internet, du World Wide Web et du Projet Génome Humain, nous avons discuté des normes internationales et de l’infrastructure de technologies de l'information à développer pour partager et intégrer les données d’une manière sécurisée, contrôlée et interprétable, afin de libérer le potentiel de découverte tout en respectant l’autonomie et la confidentialité des patients. Le groupe est parvenu à la conclusion que les besoins du patient, des communautés de la recherche et de la clinique pouvaient être satisfaits en créant les entités suivantes. Une Global Alliance de partenaires internationaux, ayant pour mission de favoriser des progrès rapides en biomédecine, et collaborant pour définir et maintenir l’interopérabilité des normes techniques de gestion et de partage des données génomiques dans les échantillons cliniques, pour élaborer des recommandations et harmoniser les procédures en matière de confidentialité et de déontologie, et pour inciter les parties prenantes dans tous les secteurs à partager les données et les procédés de manière responsable et volontaire. Une Plateforme ouverte d’informations qui utilise des normes relatives au stockage sécurisé, aux protocoles de transfert pour le partage d’informations à plusieurs niveaux, au consentement centralisé du participant, aux outils de traitement des données prenant en charge les principales plateformes de séquençage, à un procédé de comparaison des résultats d’analyses entre les centres et les technologies et à une architecture de calcul et une interface de programmation d’application (API) prenant en charge des « applications » et des services innovants. L’Alliance comprendra également des Entités opérationnelles qui instancient la Plateforme, s’engagent envers des principes communs, fournissent des services et regroupent les données pour les utilisateurs, développent des outils, suscitent l'innovation et font ainsi progresser la recherche et l’apprentissage, l’application et la pratique. Un puissant effet de réseau sera induit par l’interopérabilité sécurisée et digne de confiance des données génomiques et des outils : plus les données et les procédés peuvent interagir sur une plateforme commune, plus ils deviendront précieux pour les patients, les chercheurs et les professionnels de la santé. Ce document se concentre sur la création de l’Alliance et il se divise en trois chapitres : le Chapitre 1 présente le contexte, le Chapitre 2 examine les aspects déontologiques et techniques qui constitueront un axe majeur des travaux de l’Alliance, et le Chapitre 3 ébauche la voie pour créer la Global Alliance. 3 Chapitre 1. Présentation du contexte 4 Pourquoi maintenant ? La médecine est en pleine révolution, alimentée par la possibilité de réunir à peu de frais des informations sur la séquence du génome de nombreux individus. Le coût du séquençage d’un génome individuel atteindra probablement 1 000 dollars dans les années qui viennent. Il semble par conséquent inévitable que le génome de millions de personnes soit séquencé dans les temps à venir. Les principales difficultés concerneront de plus en plus la gestion, l’analyse, l’intégration et l’interprétation des données, plutôt que leur génération. L’opportunité. En principe, il devrait être possible d’accélérer drastiquement les progrès médicaux par l’utilisation des données mondiales sur les séquences de génome et les phénotypes cliniques, ce qui éclairera les bases biologiques du cancer, des maladies infectieuses, des maladies héréditaires et de la réponse aux médicaments. Le regroupement et l’analyse de grandes quantités de données génomiques et cliniques devrait permettre d’identifier des profils qui, dans le cas contraire, resteraient obscurs – par exemple, quelles sont les mutations identifiées dans une tumeur qui prédisent la réponse au traitement, ou quels sont les variants génétiques qui expliquent des maladies infantiles rares. L’interprétation clinique de séquences individuelles de génome sera grandement améliorée en comparant celles-ci avec des données abondantes sur la variation de séquence du génome et le phénotype. À l’heure actuelle, il n’est en général pas possible de prédire les changements dans la séquence d’ADN qui entraînent des conséquences cliniques. Leur comparaison à un vaste référentiel d’autres données du même type devrait permettre d’identifier des profils et des relations fortes. Étant donné la grande variété des critères d’évaluation des maladies, la biogéographie variée et les fréquences faibles des variations de séquences, il sera nécessaire de recueillir les données issues de millions d'échantillons. La difficulté. Malgré les avantages clairs de l’intégration des données, les communautés scientifiques et médicales ne sont pas encore organisées pour saisir cette opportunité – et elles ne prennent pas non plus le chemin pour y parvenir. À l’heure actuelle, on analyse en général les données
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