Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Composition 568061</b></p><a name=\"568061\"> </a><a name=\"hc568061\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 2; Last updated: 2026-05-30 21:56:03+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-m11-report-section-04.html\">M11ReportSection04</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}\">Active</span></p><p><b>url</b>: <a href=\"https://fevir.net/resources/Composition/568061\">https://fevir.net/resources/Composition/568061</a></p><p><b>identifier</b>: FEvIR Object Identifier/568061</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://loinc.org 35528-9}\">CeSHarP Report</span></p><p><b>category</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218533}\">section4-trial-design</span></p><p><b>date</b>: 2026-05-30 21:56:03+0000</p><p><b>author</b>: Brian S. Alper, MD, MSPH</p><p><b>title</b>: M11 Report Section 4 (Trial Design) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example</p><p><b>custodian</b>: <a href=\"Organization-118079.html\">Computable Publishing LLC</a></p><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Derived From</p><p><b>target</b>: <a href=\"ResearchStudy-267245.html\">A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Cite As</p><p><b>target</b>: </p><div><p>M11 Report Section 4 (Trial Design) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568061. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568061. Computable resource at: https://fevir.net/resources/Composition/568061#json.</p>\n</div></blockquote></div>"
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"title" : "Trial Design",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This is a Phase 3, multicenter, randomized, open-label, active comparator, single-dose, 2-period, 2-treatment, crossover study in Japanese patients with T1DM and T2DM. The study consists of a screening period; treatment period 1 (Period 1); washout period; treatment period 2 (Period 2); follow-up period. Figure IGBJ.1 illustrates the study design. Prior to the study drug administration on Period 1 Day 1, patients will be randomly assigned to a treatment sequence (either LY900018 in Period 1 and IMG in Period 2, or vice versa). Safety data will be reviewed after the first 6 patients (regardless of type of diabetes) are administered LY900018 in Period 2, and the remaining patients will be dosed after confirmation of the safety. The investigator and Lilly clinical research physician (CRP) or scientist will review available safety data, including AEs, SAEs, vital signs, electrocardiograms (ECGs), and safety laboratory tests, from these patients after they complete Period 2 Day 1. If no clinically significant safety findings for treatment or study procedure are noted, the remaining patients will be dosed. In each treatment period, patients will undergo a procedure to induce hypoglycemia using IV insulin infusion and serial blood sampling will be conducted to monitor bedside PG for safety. The insulin infusion will be stopped once the PG level reaches <60 mg/dL and approximately 5 minutes later patients will be administered either 3 mg LY900018 or 1 mg IMG (GlucaGen). Serial blood sampling will be performed for glucagon (for pharmacokinetics [PK]) and PG (for pharmacodynamics [PD]) concentration measurements immediately before and up to 4 hours following the administration of glucagon. In each period, patients will remain in the CRU for at least 6 hours after glucagon administration. All patients will receive a carbohydrate-rich meal prior to discharge. Patients may stay longer as needed, at the discretion of the investigator.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[If applicable, describe any stakeholder (for example, patient, healthcare professional and patient advocacy groups) involvement in the design of the trial and any suggestions implemented.]</div>"
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{
"title" : "Rationale for Trial Design",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Enter Overall Rationale for Trial Design, if not using below optional subheadings.]</div>"
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"title" : "Rationale for Estimand(s)",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[When estimands are associated with the Primary and Secondary Objectives described in Section 3 Trial Objectives and Associated Estimands, provide a rationale for the estimand(s) not described elsewhere in the document. This should include a rationale that the selected endpoint(s) are clinically relevant and provide a reliable and valid measurement of the intended intervention effect. It should also include a rationale for the selected strategies for handling intercurrent events.]</div>"
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{
"title" : "Rationale for Intervention Model",
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"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This study design involves an open-label assessment of 3 mg LY900018 compared to 1 mg of the marketed IMG (GlucaGen). The study will be open label because the different administration routes (ie, intranasal and IM) cannot be blinded. The use of a crossover design allows each patient to serve as his or her own control, thereby reducing variability. The washout period of 3 to 14 days is considered sufficient based on the short half-life of LY900018 (t1/2 = approximately 25 minutes). Since the critical role of glucagon in the treatment of severe hypoglycemia is to raise the PG level sufficiently to restore cognition to the point where oral carbohydrate can be ingested, treatment success is defined either as an increase in PG returning to normal level of ≥70 mg/dL or an increase of ≥20 mg/dL from the PG nadir within 30 minutes after receiving glucagon, without the patient receiving additional actions to increase glucose. It is believed that an expected PG nadir of approximately 50 mg/dL (approximately 5 minutes after stop of insulin infusion at 60 mg/dL) is low enough to generate clinical symptoms in most participants and is high enough to avoid impairment of consciousness. The primary analysis includes both patients with T1DM and T2DM since it is expected that the proportion of treatment success is similar between patients with T1DM and T2DM.</p></div>"
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},
{
"title" : "Rationale for Control Type",
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"text" : "section4.2.3-rationale-comparator"
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"status" : "empty",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[If applicable, provide a rationale for the type and choice of control selected for the trial (e.g., placebo, active drug, combination, external). Describe any known or potential problems associated with the control group selected in light of the specific disease and intervention(s) being studied. If comparators will differ by region, describe. The rationale for dose/dose regimen is explained in Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen.]</div>"
}
},
{
"title" : "Rationale for Trial Duration",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Provide a rationale that the trial duration is appropriate for a reliable and relevant evaluation of the trial intervention per the trial objective(s).]</div>"
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},
{
"title" : "Rationale for Adaptive or Novel Trial Design",
"code" : {
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"code" : "C218541",
"display" : "ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design"
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"text" : "section4.2.5-rationale-adaptive"
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"text" : {
"status" : "empty",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[If applicable, provide a rationale for the use of an adaptive or novel design.]</div>"
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},
{
"title" : "Rationale for Interim Analysis",
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"display" : "ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis"
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],
"text" : "section4.2.6-rationale-interim-analysis"
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"status" : "empty",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">[If applicable, provide a rationale for any interim analysis planned with respect to its purpose (for example, stopping the trial early for efficacy or futility) and timing.]</div>"
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},
{
"title" : "Rationale for Other Trial Design Aspects",
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"code" : "C218543",
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"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Not applicable</p></div>"
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}
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{
"title" : "Trial Stopping Rules",
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"text" : "section4.3-trial-stopping-rules"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Not applicable</p></div>"
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},
{
"title" : "Start of Trial and End of Trial",
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"text" : "section4.4-start-and-end"
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"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities (Section 2) for the last patient.</p></div>"
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},
{
"title" : "Access to Trial Intervention After End of Trial",
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"text" : "section4.5-access-after-trial"
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"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Patients will continue their previous insulin regimen after the study procedure has been complete</p></div>"
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IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot3.
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2026-06-02
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