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Investigator Initiated Studies Program

29/04/2022 -  

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Overview

Terumo is open to receive and to discuss study proposals to support clinical data generation of its medical devices from real world evidence, observational studies as well as from prospective studies with a focus on specific subsets of patients.
The main areas of interest for such studies are to:

  • Identify the right patient population
  • Evaluate safety, efficacy, feasibility, Quality of Life for these patients.
  • Assess Economic aspects related to the use of our products.


Initial Proposal Application

An initial proposal application, using the protocol evaluation form, includes: 

  • Required supporting documents in English
  • Principal investigator's curriculum vitae
  • Project summary to include:
    • Background
    • Objective and rationale
    • Primary endpoints
    • Project duration
  • Requested support (if any)
    • Monetary (in euros)
    • Materials
    • Equipment

  • IIS projects will be selected based on the following criteria:
    • New and original study question or study idea
    • Strong scientific rationale
    • Adequate study design
    • Focused on patient impact and clinical outcome in line with Terumo's mission - "Contributing to Society through Healthcare".



About the Investigator-Initiated Studies Program


Terumo established an internal cross-functional review process to assess the requests for support of investigator-initiated studies. A timely and complete submission will be reviewed by an internal  scientific committee and Grants & Donations committee.

Terumo may support external clinical investigations with researchers who can demonstrate clear evidence of high ethical and scientific standards that govern clinical research in human subjects as stipulated by the International Council for Harmonisation (ICH) E6(R2) Guideline for Good Clinical Practice (GCP).

Investigator-Initiated Studies Program


Investigator-initiated studies have scientific and medical merit and are developed and sponsored by an independent researcher. An IIS is conducted independently without Terumo participation or involvement. The IIS researcher may request Terumo to provide any or all of the following: funding, medical device(s), laboratory test(s)/procedure(s), equipment and training.

Responsibilities of the independent researcher:
  • Study design and conduct
  • Protocol review and approval
  • Obtaining the ethics committee and/or regulatory authority approvals, as required
  • Collecting the informed consents
  • Data analysis and interpretation
  • Publication
  • Compliance with local laws, regulations and guidelines
  • Reporting to regulatory authorities

Other responsibilities include:
  • Meeting specific milestones
  • Submitting updates to Terumo Medical Affairs personnel
  • Authoring final study report

Areas of Interest

The Holmium Platform (QuiremScoutTM microspheres, QuiremSpheresTM microspheres, Q-Suite™ software)
  • Demonstrate the value of holmium-SIRT for the treatment of primary liver cancer or liver metastases secondary to colorectal cancer (mCRC) or neuroendocrine tumors (mNET):
    • Safety and efficacy of Holmium-166 SIRT (either as stand-alone or in combination) in selected study population
    • Studies designed for understanding the role and demonstrating the value of Holmium-SIRT as an immune system modulator
    • Comparative studies in a well-defined setting
    • Real-World performance of holmium-SIRT, including data on long-term safety and side effects
    • Quality-of-Life and cost effectiveness studies

  • Use and value of the complete suite of solutions of the Holmium platform in every potential indication in terms of improved:
    • Patient selection
    • Treatment planning (e.g. personalized activity calculation)
    • Treatment and treatment evaluation

Drug-eluting microspheres transarterial chemo embolization (DEM-TACE)     
  • Studies evaluating efficacy and/or safety, including combination treatments with TACE for:
    • Primary liver cancer (HCC and Cholangiocarcinoma)
    • Secondary liver tumours

OcclusafeTM balloon catheter
  • Prospective clinical evidence demonstrating the benefit of using OcclusafeTM balloon catheter in liver and other organs (e.g. prostate) 

    Microwave Ablation   
    • Clinical evidence demonstrating the benefit and positioning in treating lesions for:
      • Lesions in liver, bone, lung, and other organs
      • Benign and/or malignant thyroid nodules

    IIS Proposal Process

    How to Submit


    The independent researcher submits a fully completed and signed Protocol Evaluation Form via email to
    IO.IIS_Management@terumo-europe.com

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