sly-kereval
commented
1 year ago Le JDV FHIR convient, en utilisant "NA" pour "précoce".
Closed sly-kereval closed 1 year ago
sly-kereval
commented
1 year ago Le JDV FHIR convient, en utilisant "NA" pour "précoce".
sly-kereval
commented
1 year ago Réunion 21/07 :
Le binding du JDV FHIR est "Example", il est donc possible de créer, si besoin, un nouveau valueset contenant les valeurs du JDV FHIR et de nouvelles valeurs (notamment phase-3-phase-4).
La liste des valeurs est à valider côté métier :
| Clinical trial type (Phase) | Correspondance FHIR | Définition FHIR |
|---|---|---|
| DM DIV ou jardé | NA (non applicable) | |
| Early Phase 1 | Designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Formerly called Phase 0. | |
| Human Pharmacology (Phase I)- First administration to humans | Phase 1 | Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients. |
| Human Pharmacology (Phase I)- Bioequivalence Study | Phase 1 | |
| Human Pharmacology (Phase I)- Other | Phase 1 | |
| Therapeutic exploratory (Phase II) | Phase 2 | Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks. |
| Therapeutic confirmatory (Phase III) | Phase 3 | Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug. |
| Therapeutic use (Phase IV) | Phase 4 | Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use |
| Phase I and Phase II (Integrated)- First administration to humans | Phase 1/Phase 2 | Trials that are a combination of phases 1 and 2. |
| Phase I and Phase II (Integrated)- Bioequivalence Study | Phase 1/Phase 2 | Trials that are a combination of phases 1 and 2. |
| Phase I and Phase II (Integrated)- Other | Phase 1/Phase 2 | Trials that are a combination of phases 1 and 2. |
| Phase II and Phase III (Integrated) | Phase 2/Phase 3 | Trials that are a combination of phases 2 and 3. |
| Phase III and phase IV (Integrated) | Ajouter : Phase 3/ Phase 4 (non existent dans FHIR) | Ajouter : combination of phases 3 and 4 |
Ci dessous les questions posées à la DGS :
sly-kereval
commented
1 year ago Voici le tableau de correspondance finalisé après échange avec la DGS, transmis par Octo le 27/07 :
| Clinical trial type (Phase) | Correspondance FHIR | Définition FHIR |
|---|---|---|
| DM DIV ou jardé | NA (non applicable) | |
| Early Phase 1 | Designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Formerly called Phase 0. | |
| Jardé phase précoce (Attention donnée à ajouter à l’export) | Phase 1 ou Phase 1/Phase 2 | |
| Human Pharmacology (Phase I) - First administration to humans | Phase 1 | Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients. |
| Human Pharmacology (Phase I) - Bioequivalence Study | Phase 1 | |
| Human Pharmacology (Phase I) - Other | Phase 1 | |
| Therapeutic exploratory (Phase II) | Phase 2 | Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks. |
| Therapeutic confirmatory (Phase III) | Phase 3 | Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug. |
| Therapeutic use (Phase IV) | Phase 4 | Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use |
| Phase I and Phase II (Integrated) - First administration to humans | Phase 1/Phase 2 | Trials that are a combination of phases 1 and 2. |
| Phase I and Phase II (Integrated) - Bioequivalence Study | Phase 1/Phase 2 | Trials that are a combination of phases 1 and 2. |
| Phase I and Phase II (Integrated) - Other | Phase 1/Phase 2 | Trials that are a combination of phases 1 and 2. |
| Phase II and Phase III (Integrated) | Phase 2/Phase 3 | Trials that are a combination of phases 2 and 3. |
| Phase III and phase IV (Integrated) | Phase 3/ Phase 4 (non existent dans FHIR) | Trials that are a combination of phases 2 and 3. |
sdemeyANS
commented
1 year ago Il faut donc :
sdemeyANS
commented
1 year ago Il faut donc :
- [x] ajouter la valeur manquante dans la jdv https://hl7.org/fhir/R4/valueset-research-study-phase.html
- [ ] créer la concepmap et le codesystem pour faire la correspondance ECLAIRE/FHIR pour plus de lisibilité
Je traite que le 1er point pour le mvp
Description du problème
Dans son mail du 12/07, Octo indique concernant la phase de l'essai : Pour le CTIS il s’agit bien d’une phase 1 2 ou 3, donc qui peut être qualifié. Mais pour la réglementation JARDE on a phase précoce oui ou non (donc pas forcément qualifiable de codable concept).
Solution proposée
Dans le JDV FHIR, il y a les valeurs « early-phase-1 » ou « NA », est-ce que cela pourrait correspondre pour « précoce » ? Si le JDV FHIR n’est pas adapté, il est possible de créer un JDV spécifique.