Comités de surveillance et de suivi des essais cliniques : Questions médicales fréquentes
Nom anglais: Clinical Trials Data Monitoring Committees
Descriptor UI:D026661
Tree Number:N05.700.685.149
Termes MeSH sélectionnés :
Problem-Based Learning
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"description": "Quel est le rôle principal d'un DSMB ?\nQui compose un comité de surveillance ?\nÀ quelle fréquence un DSMB se réunit-il ?\nComment un DSMB prend-il des décisions ?\nQue se passe-t-il en cas de problème de sécurité ?",
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"description": "Comment les données sont-elles analysées par le DSMB ?\nQuelles données sont surveillées par le DSMB ?\nLe DSMB peut-il modifier le protocole d'essai ?\nComment le DSMB communique-t-il ses résultats ?\nLe DSMB a-t-il le pouvoir d'arrêter un essai ?",
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"description": "Quelles compétences sont nécessaires pour un membre du DSMB ?\nComment les membres du DSMB sont-ils formés ?\nLe DSMB nécessite-t-il une formation continue ?\nComment le DSMB évalue-t-il ses propres performances ?\nLes membres du DSMB doivent-ils être indépendants ?",
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"name": "Quel est le rôle principal d'un DSMB ?",
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"text": "Évaluer la sécurité des participants et l'intégrité des données durant l'essai."
}
},
{
"@type": "Question",
"name": "Qui compose un comité de surveillance ?",
"position": 2,
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"text": "Des experts indépendants en médecine, statistique et éthique, sans conflit d'intérêt."
}
},
{
"@type": "Question",
"name": "À quelle fréquence un DSMB se réunit-il ?",
"position": 3,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les réunions sont programmées selon le protocole, souvent tous les 6 mois ou selon besoin."
}
},
{
"@type": "Question",
"name": "Comment un DSMB prend-il des décisions ?",
"position": 4,
"acceptedAnswer": {
"@type": "Answer",
"text": "Sur la base des données de sécurité et d'efficacité, en suivant des critères prédéfinis."
}
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"@type": "Question",
"name": "Que se passe-t-il en cas de problème de sécurité ?",
"position": 5,
"acceptedAnswer": {
"@type": "Answer",
"text": "Le DSMB peut recommander l'arrêt de l'essai ou des modifications pour protéger les participants."
}
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{
"@type": "Question",
"name": "Pourquoi l'éthique est-elle cruciale pour un DSMB ?",
"position": 6,
"acceptedAnswer": {
"@type": "Answer",
"text": "Pour garantir la protection des participants et l'intégrité scientifique de l'essai."
}
},
{
"@type": "Question",
"name": "Comment le DSMB assure-t-il l'équité ?",
"position": 7,
"acceptedAnswer": {
"@type": "Answer",
"text": "En s'assurant que tous les participants reçoivent un traitement équitable et juste."
}
},
{
"@type": "Question",
"name": "Le DSMB peut-il influencer les résultats de l'essai ?",
"position": 8,
"acceptedAnswer": {
"@type": "Answer",
"text": "Non, il doit rester impartial et ne pas interférer avec le déroulement de l'essai."
}
},
{
"@type": "Question",
"name": "Comment le DSMB gère-t-il les conflits d'intérêt ?",
"position": 9,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les membres doivent déclarer tout conflit d'intérêt et s'en retirer si nécessaire."
}
},
{
"@type": "Question",
"name": "Quel est l'impact d'un DSMB sur la confiance du public ?",
"position": 10,
"acceptedAnswer": {
"@type": "Answer",
"text": "Un DSMB renforce la confiance en garantissant la sécurité et l'intégrité des essais."
}
},
{
"@type": "Question",
"name": "Comment les données sont-elles analysées par le DSMB ?",
"position": 11,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les données sont examinées statistiquement pour détecter des tendances ou des anomalies."
}
},
{
"@type": "Question",
"name": "Quelles données sont surveillées par le DSMB ?",
"position": 12,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les événements indésirables, l'efficacité du traitement et la conformité au protocole."
}
},
{
"@type": "Question",
"name": "Le DSMB peut-il modifier le protocole d'essai ?",
"position": 13,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, il peut recommander des modifications pour améliorer la sécurité ou l'efficacité."
}
},
{
"@type": "Question",
"name": "Comment le DSMB communique-t-il ses résultats ?",
"position": 14,
"acceptedAnswer": {
"@type": "Answer",
"text": "Il rédige des rapports réguliers pour les sponsors et les autorités réglementaires."
}
},
{
"@type": "Question",
"name": "Le DSMB a-t-il le pouvoir d'arrêter un essai ?",
"position": 15,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, il peut recommander l'arrêt d'un essai pour des raisons de sécurité ou d'éthique."
}
},
{
"@type": "Question",
"name": "Quelles compétences sont nécessaires pour un membre du DSMB ?",
"position": 16,
"acceptedAnswer": {
"@type": "Answer",
"text": "Compétences en médecine, statistique, éthique et gestion des essais cliniques."
}
},
{
"@type": "Question",
"name": "Comment les membres du DSMB sont-ils formés ?",
"position": 17,
"acceptedAnswer": {
"@type": "Answer",
"text": "Ils reçoivent une formation sur les protocoles d'essai, l'éthique et l'analyse des données."
}
},
{
"@type": "Question",
"name": "Le DSMB nécessite-t-il une formation continue ?",
"position": 18,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, pour rester à jour sur les meilleures pratiques et les nouvelles réglementations."
}
},
{
"@type": "Question",
"name": "Comment le DSMB évalue-t-il ses propres performances ?",
"position": 19,
"acceptedAnswer": {
"@type": "Answer",
"text": "Par des évaluations régulières et des retours d'expérience sur ses décisions et processus."
}
},
{
"@type": "Question",
"name": "Les membres du DSMB doivent-ils être indépendants ?",
"position": 20,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, pour éviter les biais et garantir l'intégrité des évaluations et décisions."
}
},
{
"@type": "Question",
"name": "Comment les résultats du DSMB sont-ils partagés ?",
"position": 21,
"acceptedAnswer": {
"@type": "Answer",
"text": "Ils sont communiqués aux sponsors et aux autorités, souvent sous forme de rapports."
}
},
{
"@type": "Question",
"name": "Les résultats du DSMB sont-ils publiés ?",
"position": 22,
"acceptedAnswer": {
"@type": "Answer",
"text": "Généralement, les résultats globaux de l'essai sont publiés, mais pas les délibérations internes."
}
},
{
"@type": "Question",
"name": "Le DSMB informe-t-il les participants des résultats ?",
"position": 23,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les participants sont informés des résultats pertinents, mais pas des détails internes."
}
},
{
"@type": "Question",
"name": "Comment le DSMB contribue-t-il à la transparence ?",
"position": 24,
"acceptedAnswer": {
"@type": "Answer",
"text": "En fournissant des rapports clairs et en respectant les normes éthiques de communication."
}
},
{
"@type": "Question",
"name": "Le DSMB peut-il recommander la publication des résultats ?",
"position": 25,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, il peut suggérer la publication si les résultats sont significatifs et éthiques."
}
}
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}
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Constructive feedback is key to successful teaching and learning. The unique characteristics of problem-based learning (PBL) tutorials require a unique feedback intervention. Based on the review of ex...
This study employed a qualitative research design. The model was tested in nine online PBL sessions, selected using the maximum variation sampling strategy based on tutors' characteristics. All sessio...
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to assess the preliminary effect of Problem-Based Learning on Care Management skills....
a quasi-experimental pre- and post-test conducted with students attending the Bachelor's Degree in Nursing offered by an educational institution. The sample was comprised by 29 (Experimental Group) an...
the Experimental Group obtained higher scores in analytical, action-related and global skills than the Control Group (p<0.05). No differences were recorded in interpersonal skills or in use of the inf...
despite the fact that there is little evidence on the development of Nursing Care Management skills, the current study shows that Problem-Based Learning is an effective and significant method in remot...
Student engagement is student investment of time and energy in academic and non-academic experiences that include learning, teaching, research, governance, and community activities. Although previous ...
A 15-item questionnaire was developed guided by a previously published conceptual framework of student engagement. Focus group discussion (n = 12) with medical education experts was then conducted and...
Confirmatory factor analysis indicates a good fit between the measurement and structural model of an 11-item questionnaire composed of a three-factor structure: behavioral engagement (3 items), emotio...
We found a strong evidence to support the construct validity of a three-factor structure of student engagement in PBL tutorial questionnaire. Further studies are required to test the validity of this ...
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This mixed-methods study was conducted in an Asian medical school. First, a survey was administered to two groups of students, one that had been tutored by near-peers, and another with faculty tutors....
Our study found no difference between near-peer tutees' and faculty tutees' perceptions of either tutor facilitation or tutor behaviours. Also, when near-peer tutors explained how their experience of ...
Integrating near-peer teaching into undergraduate medical curricula could be beneficial to both tutors and tutees because of the social, cognitive, and professional congruence between these two groups...
Problem-based learning (PBL) allows higher thinking among dental students and has improved first-time pass-rates in predoctoral pediatric dentistry education. The aim of this retrospective observation...
Student performance and perceptions after receiving dental trauma curriculum with or without PBL-based dental trauma case discussions were evaluated. All the students challenged their simulated patien...
For the PBL cohort, there was a significant (p > 0.05) improvement in the first-time pass-rates and scores in three out of four competencies. A higher proportion of students in the PBL cohort perceive...
The PBL-based dental trauma case discussion had a positive impact on predoctoral student learning and perceived benefits while managing simulated traumatic dental injuries. Due to a lack of correlatio...