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En Belgique, nous menons des essais cliniques dans les différents domaines thérapeutiques du pipeline de GSK. Pendant de nombreuses années, nous avons mené avec succès des essais de vaccins en collaboration avec nos sites de vaccination partenaires. Nous comptons également un volume relativement élevé d'études de phase précoce en Belgique, ainsi qu'un nombre croissant d'études en oncologie.

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Accéder à toutes les données de nos essais au niveau mondial

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laboratoire","darkModeSrc":"/media/ewrlhy44/etudes-cliniques.jpg?width=1320&height=660&format=webp&quality=90&v=1dc061ab61ef230"},"link":null,"isFullPageWidth":false,"disableRoundedCorners":false,"expandableToAnOverlay":false,"portraitCrop":false,"cropTo75Width":false,"noCrop":false,"caption":"","title":null,"ariaHidden":false,"ariaFlipCard":"Flip card {title}","ariaImageButton":null},{"type":"spacer","label":""},{"type":"rich-text","text":"

\n

Découvrez notre processus d'essais cliniques

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Les maladies et les médicaments peuvent affecter les gens différemment selon leur ethnie, leur sexe ou leur âge. Il est donc essentiel que nous représentions la population réelle de la maladie dans nos essais cliniques afin de faire progresser notre compréhension des nouveaux médicaments et vaccins et d'obtenir de meilleurs résultats pour les patients qui comptent sur nous. 

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Les études cliniques sont régies par des règles strictes. Tout au long d’une étude, les procédures sont contrôlées par les autorités publiques, ainsi que par le propre comité de sécurité de GSK (Global Safety Board, GSB).

\n

Un plan de développement clinique se compose généralement de trois phases. Dans certains cas, une quatrième phase peut être nécessaire si : 

\n","useGreyBackground":false,"fullWidth":false},{"type":"tabs","tablistAriaLabel":"","tabs":[{"title":"Phase I","items":[{"type":"rich-text","text":"

La première fois qu’un nouveau traitement ou vaccin est testé sur des êtres humains, il est habituellement administré à un petit groupe de volontaires en bonne santé. Toutefois, dans certains cas – comme lorsqu’il s’agit de tester un nouveau médicament pour le traitement d’une maladie en phase terminale telle qu’un cancer – celui-ci peut être testé sur des volontaires atteints de la maladie en question.

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Les principaux objectifs de la Phase I sont les suivants :

\n","useGreyBackground":false,"fullWidth":false}]},{"title":"Phase II","items":[{"type":"rich-text","text":"

Si la Phase I est couronnée de succès, les chercheurs demandent l’autorisation d’élargir l’étude à un plus grand groupe de personnes. Les études de Phase II incluent généralement (mais pas toujours) des patients qui souffrent de la maladie ciblée par le nouveau médicament étudié et visent à établir :

\n\n

À ce stade, les performances du médicament peuvent être comparées par rapport à un groupe de patients mis sous placebo. Un placebo est un traitement qui ressemble au nouveau médicament étudié, mais qui ne contient pas de substance active.

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Son utilisation permet de composer un groupe de référence, pour une évaluation objective des résultats obtenus par le nouveau médicament. Ni les patients, ni les chercheurs ne doivent savoir qui reçoit quoi. C’est ce qu’on appelle un contrôle placebo en double aveugle, qui est très important pour garantir que les résultats rapportés ne soient pas biaisés.

","useGreyBackground":false,"fullWidth":false}]},{"title":"Phase III","items":[{"type":"rich-text","text":"

Si les résultats de la Phase II sont encourageants, nous envisageons le démarrage d’une ou de plusieurs études de Phase III. Ces études sont beaucoup plus larges, impliquant souvent des centaines, voire des milliers de participants issus de plusieurs pays différents.

\n

Les principaux objectifs de la Phase III sont les suivants :

\n\n

Si un nouveau médicament ou vaccin produit des résultats positifs en fin de Phase III, nous demandons aux autorités d’approuver sa mise sur le marché dans divers pays ou régions.

\n

Dans le cas d’un nouveau médicament, les autorités chargées de l’enregistrement détermineront, sur la base de toutes les données issues des études précliniques et cliniques, la manière dont il doit être utilisé et les patients qui peuvent le prendre. C’est ce qu’on appelle l’indication du médicament.

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Surveillance du médicament après sa mise sur le marché

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La surveillance est assurée par notre comité de sécurité (Global Safety Board, GSB), présidé par notre directeur médical et composé de médecins et de scientifiques aguerris, ainsi que par les autorités sanitaires qui ont approuvé la mise sur le marché du produit.

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Sa mission consiste notamment à étudier les informations relatives à la sécurité de nos produits, telles qu’elles nous sont communiquées par les patients ou les prescripteurs qui l’utilisent sur le terrain.

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Le comité de sécurité prend toutes ses décisions sur la base d’un seul et même principe : les bénéfices de nos médicaments et vaccins doivent toujours l’emporter sur les risques qui y sont associés. Nous surveillons continuellement les réponses des patients à nos médicaments par le biais de notifications et de systèmes nationaux de déclaration. Nous suivons ces données pour nous assurer une compréhension complète de l’efficacité d’un nouveau médicament. Nous restons également attentifs à tout nouvel effet indésirable qui pourrait n’apparaître qu’à partir du moment où le médicament est utilisé à grande échelle.

","useGreyBackground":false,"fullWidth":false},{"type":"spacer","label":""},{"type":"rich-text","text":"

Signaler un effet indésirable

\n

Pour la Belgique

\n

Veuillez signaler les effets indésirables au Centre Belge de Pharmacovigilance pour les médicaments à usage Humain (CBPH) de l’Agence Fédérale des Médicaments et des Produits de Santé (AFMPS) selon la procédure décrite sur le site http://www.fagg-afmps.be ou à GlaxoSmithKline Pharmaceuticals s.a./n.v. au numéro +32 (0)10 85 85 00.

\n

Pour le Luxembourg

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Veuillez signaler les effets indésirables au Ministère de la Santé du Grand-Duché de Luxembourg (Division de la Pharmacie et des Médicaments au numéro de fax +35 (0)2 24795615 ou par courrier postal) ou au Centre Régional de Pharmacovigilance de Lorraine (numéro de fax +33 (0)3 83 32 33 44 ou crpv@chu-nancy.fr) ou à GlaxoSmithKline Pharmaceuticals s.a./n.v. au numéro +32 (0)10 85 85 00.

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