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Investigator Initiated Trials Taiho Oncology is focused on the development of orally administered anti-cancer agents for a wide range of tumor types.
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PROVIDING FUNDING OPPORTUNITIES FOR INVESTIGATOR-INITIATED TRIALS

Investigator Initiated Trial (IIT) refers to submission of an unsolicited clinical trial proposed and sponsored by an Investigator at a hospital, medical center, medical school, private foundation, private practice, group practice, or government-sponsored research network. Support is awarded based upon scientific merit, as well as alignment with our areas of interest.

IIT submissions are accepted on a rolling basis by Taiho Oncology and evaluated by an internal review committee on criteria such as scientific merit, safety, legal, ethical, and budgetary aspects. The IIT submission portal is exclusively for the submission of trial requests.

Taiho Oncology may withdraw support if a Sponsor-Investigator fails to comply with applicable legal and or regulatory obligations, provide false information in the proposal, or otherwise specified in the contract.

Sponsor-Investigators are responsible for all study related medical decisions, trial design, regulatory approval, initiation/conduct/oversight, data analysis, publications, and reporting of adverse events.

All Sponsor-Investigators who are awarded support must provide Taiho Oncology with timely study updates as defined in the contract, a final written study report and notification of all publications (e.g., posters, abstracts).

Sponsor-Investigator provides the clinical study report and ensures that all contract terms are fulfilled prior to study closure. Including:

  • Financial reconciliation of the study budget
  • Institutional Review Board/Ethics Committee close out letter
  • Documentation that all unused medicinal product was destroyed as per institutional policy
  • Adverse Event reconciliation

Final written report detailing the methodology and results of the trial as specified in the contract.

Notification of all publications (e.g., posters, abstracts) should be provided as specified in the contract.

Investigator-Initiated Trials support by Taiho Oncology is only provided in response to an unsolicited written request and not conditioned on the use, purchase, prescribe, or recommendation of any Taiho Oncology product.

Submissions are accepted on an ongoing basis and must align with our areas of interest in Aesthetics, Consumer Care and Prescription medicine. Only products approved by the U.S. Food and Drug Administration may be provided to support IISs. To view our current areas of interest and portfolio of products available for request, please visit www.Taiho.com/us.

The following IIS study types may be considered for support:

  • Prospective clinical or preclinical studies involving Taiho products
  • Non-interventional research, such as epidemiology or outcomes studies, where the focus is on scientific understanding of the disease
  • In vitro and in vivo studies

We do not provide support for the following:

  • Proposals that are not aligned with our current areas of interest
  • Studies that have already started or are completed
  • Proposals that are conditioned upon past or future prescriptions or purchases of Taiho products
  • Requests that create a conflict of interest for Taiho

Investigator-Initiated Trials support by Taiho Oncology is only provided in response to an unsolicited written request and not conditioned on the use, purchase, prescribe, or recommendation of any Taiho Oncology product.

To begin the process of submitting a proposal for initial evaluation, the submitter will be required to create and access a Taiho Oncology portal account and then complete a submission form and attach required documents. A complete and detailed submission will facilitate management and evaluation of your proposal.

  1. Complete submission form
  2. Attach required documents:
    • Study Proposal
    • Principal Sponsor-Investigator's Curriculum Vitae
    • Budget
  3. Submit proposal
  4. Taiho Oncology will send an email notification acknowledging receipt of submission.
  5. Incomplete submissions that do not include required documents will not be processed until all requested information is received and will be returned to the submitter.
  6. Upon receipt of a complete application and review by the internal review committee, Taiho Oncology will notify the submitter of the proposal review decision.

If approved, the full protocol must be submitted within 90 days of the study proposal approval notification.

Funding will be provided for approved protocols upon contract execution.

Investigator-Initiated Trials support by Taiho Oncology is only provided in response to an unsolicited written request and not conditioned on the use, purchase, prescribe, or recommendation of any Taiho Oncology product.

We will consider reasonable requests for funding in support of an IIS. All full proposal submissions must include an itemized budget with costs based on fair market value (FMV) evaluations to ensure that the amount of support is appropriate. Requestors may use their own template or the Taiho template that is provided here. Line item allocations should be specified for each aspect of the study, such as study start-up fees (e.g., IRB submission), study visits (e.g., physical exam, vital signs, pregnancy test), and publication costs (e.g., medical writer).

For study-specific items, or equipment that may be required, please provide a rental estimate from a vendor of choice. Please note that we do not provide support for the following:

  • Salary and/or benefit payments for Investigators or study staff
  • Education/training activities
  • Costs that are deemed in excess of fair market value
  • Capital equipment purchases (associated rental fees will be considered)
  • Construction funds to build new facilities

QUESTIONS?

In the United States: Contact your Medical Science Liaison or email us at IITShared@taihooncology.com
In Europe: Contact your Taiho Medical Director

RESEARCH PORTAL USER GUIDE

Download a user guide to assist you in the submission of your request.

Research Portal User Guide

FREQUENTLY ASKED QUESTIONS

Follow instructions provided on the HOW TO APPLY tab, or you may access the user guide for additional guidance.
Click on CREATE ACCOUNT in the top menu, or download the user guide for additional information.

  • Use the "Forgot Password?" link to reset your password.
  • If you do not receive the password reset email in your inbox, please check your Junk or Spam folder.

You may view the status of your submission via the MY SUBMISSIONS tab after you've logged into your account.

Investigator-Initiated Trials support by Taiho Oncology is only provided in response to an unsolicited written request and not conditioned on the use, purchase, prescribe, or recommendation of any Taiho Oncology product.

We are committed to maintaining integrity in all of our professional relationships. We operate under the highest ethical standards and in full compliance with all applicable laws, regulations, industry codes, and guidelines. Approval of IIS support is never related to or conditioned upon past or future prescriptions or purchases of Taiho products. Furthermore, we do not offer, or provide funding to encourage or to reward the prescription, purchase, ordering, or recommending of Taiho products.

Our grant review and approval process is in full accordance with the recommendations and the guidance of the U.S. Food and Drug Administration (FDA), the Pharmaceutical Research and Manufacturers Association (PhRMA), the Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interaction with Health Care Professionals, the AdvaMed Code of Ethics on Interactions with Health Care Providers, and National Physician Payment Transparency Program: Open Payments "Physician Payment Sunshine Act", as well as internal Taiho policies.

By submitting materials for review, you agree that the information is not confidential, nor proprietary, and may be referred to a number of different persons at Taiho to determine the level of interest in supporting your request.

Publications or other presentation of data derived from the IIS must be marked with an acknowledgement that the study was conducted with financial and/or in-kind support from Taiho, as a collaborator.

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