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Narrative

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Source1

{
  "resourceType": "ResearchStudy",
  "id": "BreastCancerTrial",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "identifier": [
    {
      "system": "http://clinicaltrials.gov/",
      "value": "NCT01234567",
      "assigner": {
        "display": "Allesgut Pharmaceuticals"
      }
    }
  ],
  "title": "Breast Cancer Clinical Trial bresentrik study",
  "protocol": [
    {
      "display": "This would reference the PlanDefinition which would contain references to Bresentrik"
    }
  ],
  "status": "active",
  "primaryPurposeType": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type",
        "code": "treatment",
        "display": "Treatment"
      }
    ]
  },
  "phase": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "code": "phase-2-phase-3"
      }
    ]
  },
  "studyDesign": [
    {
      "coding": [
        {
          "system": "http://hl7.org/fhir/study-design",
          "code": "SEVCO:01001",
          "display": "Interventional research"
        }
      ]
    }
  ],
  "condition": [
    {
      "coding": [
        {
          "system": "http://snomed.info/sct",
          "code": "254837009",
          "display": "Breast Cancer"
        }
      ]
    }
  ],
  "description": "Eligible participants will be those diagnosed with HER2-positive (IHC 3+ or ISH+), metastatic breast cancer, who have received no prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer. The study aims to evaluate the efficacy, and safety of bresentrik, alone or with pertuzumab, compared with the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). This study aims to see if bresentrik allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.",
  "period": {
    "start": "2021-03-23",
    "end": "2029-03-23"
  },
  "site": [
    {
      "display": "This would be a reference to a Location containing the facility where the trial is taking place"
    }
  ],
  "associatedParty": [
    {
      "name": "Iam Recruitment Contact",
      "role": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-party-role",
            "code": "recruitment-contact",
            "display": "recruitment-contact"
          }
        ]
      },
      "classifier": [
        {
          "text": "Contact"
        }
      ],
      "party": {
        "type": "Practitioner",
        "display": "This would be a reference which would provide phone number"
      }
    },
    {
      "name": "Alebund Pharmaceuticals",
      "role": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-party-role",
            "code": "sponsor",
            "display": "sponsor"
          }
        ]
      },
      "classifier": [
        {
          "text": "INDUSTRY"
        }
      ],
      "party": {
        "display": "This would be a reference Organization and would be the body legally responsible for the trial"
      }
    },
    {
      "name": "Alebund Pty Ltd",
      "role": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-party-role",
            "code": "lead-sponsor",
            "display": "lead-sponsor"
          }
        ]
      },
      "classifier": [
        {
          "text": "INDUSTRY"
        }
      ],
      "party": {
        "type": "Practitioner",
        "display": "This would be a reference Organization and would be the body legally responsible for the trial"
      }
    },
    {
      "name": "Sam Francis, Doctor",
      "role": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-party-role",
            "code": "primary-investigator",
            "display": "primary-investigator"
          }
        ],
        "text": "Principal Investigator"
      },
      "party": {
        "display": "This would be a reference to a Practitioner or PractionerRole"
      }
    }
  ],
  "recruitment": {
    "eligibility": {
      "display": "This would be a reference to a Group, use Group.characteristic to define inclusion and exclusion criteria"
    }
  },
  "comparisonGroup": [
    {
      "name": "Arm A",
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-arm-type",
            "code": "experimental",
            "display": "Experimental"
          }
        ]
      },
      "description": "Bresentrik (B) plus pertuzumab-matching placebo"
    },
    {
      "name": "Arm B",
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-arm-type",
            "code": "experimental",
            "display": "Experimental"
          }
        ]
      },
      "description": "Bresentrik (B) plus pertuzumab"
    },
    {
      "name": "Arm C",
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-arm-type",
            "code": "active-comparator",
            "display": "Active Comparator"
          }
        ]
      },
      "description": "Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)"
    }
  ]
}