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International audience; Limited access to nucleic acid testing (NAT) to quantify HBV DNA levels, an essential tool to determine anti-HBV treatment eligibility, represents a significant barrier to scale up HBV diagnostic services in resource-limited countries. Hepatitis B core-related antigen (HBcrAg) has the potential to become an affordable alternative because of its low cost (US$

Resume Le developpement clinique de medicaments disease-modifiers dans la maladie d’Alzheimer se heurte a des difficultes methodologiques dont temoignent plusieurs echecs recents de medicaments en phase III. Compte-tenu des enjeux financiers inherents au passage en phase III et du risque d’investir en pure perte de l’energie pour l’evaluation d’un mauvais candidat-medicament, la question cruciale reste la decision de go/no go entre la phase II et la phase III dont l’objectif est certes de selectionner une molecule susceptible d’etre efficace en phase III mais plus encore d’ecarter d’un developpement ulterieur les candidats aux effets insuffisants. Aucun consensus n’existe aujourd’hui sur la meilleure conception possible des etudes de phase II pour tenter d’eclairer au mieux la decision de go/nogo. Les difficultes de choix de la meilleure conception d’etude concernent tout aussi bien la population-cible, les criteres de jugement en particulier le recours a des biomarqueurs, le plan experimental ou la duree des etudes. L’objet de la Table Ronde (TR) a ete de rassembler les points de vue d’experts francais issus du monde academique, industriel ou reglementaire afin d’arriver a une proposition consensuelle sur la meilleure conception possible que devraient utiliser les etudes de phase II dans la maladie d’Alzheimer.

As the failure of several recent Phase III drug development programmes bears witness, the clinical development of “disease-modifying” drugs in Alzheimer’s disease has been confronted with challenging methodological difficulties. Taking into account the financial stakes involved taking drug candidates to the Phase III stage of development, and the risk of investing time and resources fruitlessly in the evaluation of poor candidate drugs, the crucial decision remains whether to proceed from Phase II to Phase III (Go/Nogo). The aim of Phase II studies is to select a molecule likely to be effective in Phase III, but also to eliminate candidate-drugs with an inadequate effect. No consensus currently exists on the best possible design of Phase II studies to inform the Go/Nogo decision optimally. The challenges in choosing the best study design relate to the target population, the end-point criteria used, in particular the use of biomarkers, the experimental protocol, and the study duration. The objective of the Round Table (RT) was to gather the opinions of French experts from the academic, industrial, and regulatory world in order to arrive at a consensus recommendation for the best possible design to be used in Phase II studies in Alzheimer’s disease.