ResearchStudy — Étude de recherche clinique

Le protocole formel d'une étude clinique en FHIR : essai randomisé, étude observationnelle, registre, méta-analyse, recherche translationnelle. Pont vers ClinicalTrials.gov, EU CTR, ANSM.

Objet de la ressource

ResearchStudy modélise le protocole et le statut d'une étude : objectif primaire (treatment, prevention, screening, diagnostic, supportive-care, observational), phase (I, II, III, IV), design (RCT, crossover, single-arm, cohorte), critères d'inclusion via EvidenceVariable, sites participants, parraineur, identifiants nationaux et internationaux (NCT, EudraCT, JapicCTI…).

Champs clés

Champ	Type	Cardinalité	Rôle
`url`	uri	0..1	URL canonique.
`identifier`	Identifier[]	0..*	NCT, EudraCT, JapicCTI, identifiant interne.
`title`	string	0..1	Titre scientifique.
`label`	BackboneElement[]	0..*	Titres alternatifs (acronyme, public).
`protocol`	Reference(PlanDefinition)[]	0..*	Protocoles associés.
`partOf`	Reference(ResearchStudy)[]	0..*	Étude parente (programme).
`relatesTo`	BackboneElement[]	0..*	Liens vers d'autres ResearchStudy.
`date`	dateTime	0..1	Date d'enregistrement.
`status`	code	1..1	`active \| administratively-completed \| approved \| closed-to-accrual \| closed-to-accrual-and-intervention \| completed \| disapproved \| in-review \| temporarily-closed-to-accrual \| temporarily-closed-to-accrual-and-intervention \| withdrawn`.
`primaryPurposeType`	CodeableConcept	0..1	Objectif primaire.
`phase`	CodeableConcept	0..1	Phase clinique.
`studyDesign`	CodeableConcept[]	0..*	Design.
`focus`	CodeableReference[]	0..*	Sujet d'étude (Condition, Medication…).
`condition`	CodeableConcept[]	0..*	Pathologies étudiées.
`keyword`	CodeableConcept[]	0..*	Mots-clés.
`region`	CodeableConcept[]	0..*	Régions concernées.
`period`	Period	0..1	Période d'étude.
`site`	Reference(Location \| ResearchStudy \| Organization)[]	0..*	Sites participants.
`recruitment`	BackboneElement	0..1	État du recrutement (target, actual, eligibility).
`comparisonGroup`	BackboneElement[]	0..*	Bras d'étude.
`objective`	BackboneElement[]	0..*	Objectifs primaires/secondaires.
`outcomeMeasure`	BackboneElement[]	0..*	Mesures de résultat.
`result`	Reference(EvidenceReport \| Citation \| DiagnosticReport)[]	0..*	Résultats publiés.

Exemple JSON

json researchstudy-example.json

{
  "resourceType": "ResearchStudy",
  "id": "example-trial-001",
  "url": "http://example.org/ResearchStudy/example-trial-001",
  "identifier": [{
    "system": "https://clinicaltrials.gov",
    "value": "NCT05000001"
  }],
  "title": "Apixaban versus Warfarin in Non-Valvular Atrial Fibrillation",
  "status": "active",
  "primaryPurposeType": {
    "coding": [{
      "system": "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type",
      "code": "treatment"
    }]
  },
  "phase": {
    "coding": [{
      "system": "http://terminology.hl7.org/CodeSystem/research-study-phase",
      "code": "phase-3"
    }]
  },
  "studyDesign": [{
    "coding": [{
      "system": "http://terminology.hl7.org/CodeSystem/research-study-design",
      "code": "randomized-controlled-trial"
    }]
  }],
  "period": {
    "start": "2026-05-15",
    "end": "2030-12-31"
  }
}

Registres réglementaires

ClinicalTrials.gov — registre américain (NCT number).
EU CTR — registre européen unifié (EUCTR number) succédant à EudraCT.
JapicCTI — Japan Pharmaceutical Information Center.
ANSM CTIS — base française des essais cliniques.
WHO ICTRP — registre mondial.

Pièges courants

Identifier sans system — incapable de retrouver l'étude.
Status non synchronisé — le status doit refléter ClinicalTrials.gov.
Confusion focus / condition — focus est plus large.

Fondamentaux

Standards

Messages phares

Outils