[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-210957-en":3,"doc-seo-210957-105":30,"detail-sidebar-cat-0-en-105":90},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":4,"category_id":11,"category_name":12,"doc_title":13,"doc_description":14,"doc_content":15,"file_id":16,"file_url":17,"file_type":18,"file_size":19,"view_count":4,"is_deleted":4,"is_public":20,"is_downloadable":20,"audit_status":20,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":14,"update_tm":28,"read_time":29},210957,4398048950312,"Violet","https://ap-avatar.wpscdn.com/avatar/400002538284de19e3c?_k=1778320343897328908",8,"Research & Report","Building Institutional Infrastructure for Investigator-Initiated Treatment Trials - Abstract","Building Institutional Infrastructure for Investigator-Initiated Treatment Trials outlines how the Sponsor-Investigator Support (SISU) model delivers end-to-end investigator-initiated treatment trial support at Hollings Cancer Center, Medical University of South Carolina. After late-2024 restructuring expanded SISU’s scope and resources, SISU partnered with HART for concept vetting and with BSR for statistical and database oversight. Standardized regulatory, operational, and project management workflows improved activation efficiency, increased trial openings from 2024 to 2025, and strengthened scalable IIT infrastructure through defined start-up and maintenance teams.","Building Institutional Infrastructure for Investigator-Initiated Treatment Trials  \nC. Charlton  \nHollings Cancer Center, Medical University of South Carolina  \n1. Background  \nThe Sponsor-Investigator Support (SISU) provides comprehensive investigator-initiated trial (IIT) support from concept development through closeout for National Cancer Institute (NCI)-Designated Cancer Center, Hollings Cancer Center, at Medical University of South Carolina (MUSC) . Following a major reorganization in late 2024, institutional investment expanded SISU’s scope, resources, and central role in supporting investigator-initiated treatment trials.  \nSISU collaborates with the Hollings Advisory Rapid Translation (HART) committee, which vets concept rationale and design, and the Biostatistics Shared Resource (BSR) core, which oversees statistical analysis and database management, as a collaborative group to develop and operate IITs. This centralized model improves efficiency, reduces fragmentation of stakeholders, and brings together subject matter expertise to support the investigator. SISU resources integrate early in development to provide regulatory, operational, and project management support. The core scope of SISU is focused on MUSC sponsored treatment IITs, and all these studies have mandatory support from this model.  \n2. Goals  \nThe overarching aim of SISU is to support the activation and maintenance of IIT treatment trials, with a current goal to increase the number of these trials open to accrual. The SISU ensures regulatory and operational consistency and compliance, and promotes standardization across the IITs. It enables the expansion of investigator-initiated research at scale. SISU aligns concept prioritization and start-up activities with cancer center strategic priorities, including accrual growth in specific patient populations critical for achieving comprehensive cancer center status. SISU also reduces the barrier to entry for new investigators developing IITs by providing a structured project management resource throughout the study lifecycle.  \n3. Solutions and Methods  \nThe SISU works in a centralized model with the HART committee and BSR to promote success of concept development and execution. SISU maintains standardized workflows and templates, and owns protocol writing, project team meetings and action items, U.S. Food and Drug Administration (FDA) submissions, Protocol Review Committee (PRC) submissions, Institutional Review Board (IRB) submissions, Site Initiation Visit (SIV) conduct, maintenance of site regulatory binder and sponsor file, eligibility reviews, source data verification and data queries, Data Safety Monitoring Committee (DSMC) submissions and presentations, and other sponsor-level operational and regulatory responsibilities.  \nThe SISU structure includes two specialized teams – one focused on start-up and the other on trial maintenance – to streamline workflow and ensure appropriate depth of experience during the study lifecycle. The start-up team typically works with the same investigators but is flexible in assignments based on workload and are not specific to a disease type. Maintenance team staff focus on specific disease portfolios, but all team members perform eligibility reviews on all studies.  \n4. Outcomes  \nFollowing restructuring and resource expansion, trial openings rebounded significantly, rising from zero in 2024 to five in 2025, all aligned with institutional priority areas. The table below details the number of MUSC sponsored investigator-initiated treatment trials opened at Hollings Cancer Center from 2022 through February 2026.  \n\n| Year | Number of Tx IITs Opened | Disease Areas |\n| --- | --- | --- |\n| 2022 | 4 | Lung, Prostate, Oral |\n| 2023 | 3 | Lymphoma, Prostate, Sarcoma |\n| 2024 | 0 | N/A |\n| 2025 | 5 | Lung, Prostate, Ovarian, Breast, Pancreas |\n| 2026* | 2 | Brain, Prostate |\n\n*Data current as of February 26, 2026. SISU projects to exceed five trial openings in 2026.  \n5. Les","cbCaitR3Mywefrkg","https://ap.wps.com/l/cbCaitR3Mywefrkg","pdf",282889,1,2,"English","en",105,"# Background\n# Goals\n# Solutions and Methods\n# Outcomes\n# Lessons Learned and Future Directions","[{\"question\":\"What is the main purpose of the SISU model for IIT treatment trials?\",\"answer\":\"SISU supports activation and maintenance of IIT treatment trials while promoting regulatory and operational consistency and enabling accrual expansion at scale.\"},{\"question\":\"How do HART and BSR contribute within the SISU centralized structure?\",\"answer\":\"HART vets concept rationale and design, while BSR oversees statistical analysis and database management, together supporting concept development and execution.\"},{\"question\":\"What outcomes changed after the late-2024 restructuring?\",\"answer\":\"Trial openings rebounded from zero in 2024 to five in 2025, and the document reports an ongoing plan to exceed five openings in 2026.\"}]","Building Institutional Infrastructure for Investigator-Initiated Treatment Trials - 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