Takeda and its alliance partners are committed to improving patient care by supporting scientific advances in medicine and increasing our understanding of important diseases. As part of this commitment, the IISR program supports innovative clinical and basic science studies that address important medical and scientific questions related to our compounds and therapeutic areas of interest.

An IISR is defined as an unsolicited, independent, pre/non-clinical, clinical, outcomes, or disease state research study where the Investigator, organization or institution (academic, private, or governmental) serves as the Sponsor, and Takeda provides support in the form of funding,study drug, and/or authorization to reference Takeda’s NDA or other regulatory submissions (e.g., IND).

Preclinical - Requests for compounds, cell lines and animal models*
Clinical - Clinical trials, observational studies, and patient-reported outcomes research
*Animal models are available for oncology requests only

Please have the following information available at the time of your submission (additional documentation may be requested as applicable):

Concept/Protocol

  • Study hypothesis (medical/scientific question to be addressed)
  • Background & rationale
  • Study objectives
  • Inclusion/exclusion criteria
  • Study design/schedule (including treatments/procedures)
  • Study drug/vaccine
  • Patient population
  • Study endpoints
  • Safety reporting plan (for clinical studies)
  • Statistical analysis plan
  • Data management plan
  • Publication plan
  • References
  • Detailed budget
  • For studies including product, provide:
    • -Quantity of product
      -Route of administration
      -Dosing

    Amendments

  • Updated study documents reflecting amendment requests (e.g. protocol, budget, product request)
  • Updated ethics approval (after Takeda review and approval of amendment request)
  • Visit Takeda.com (研究者主導研究申請プログラムに関してはこちらから) for further information about our products and therapeutic areas of interest.

    Support for IISRs may be publicly disclosed in accordance with all local laws and regulations.
    US Physicians may refer to the Ethical Exchange Brochure or the Centers for Medicare and Medicaid Services for more information.

    Please be aware that support is awarded strictly based on research merit criteria.
    Submission of a proposal does not imply or guarantee approval. Support of a study in no way implies any obligation toward or is any
    way connected to the recommendation or prescribing of products.

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