INVESTIGATOR-INITIATED TRIALS (IITs)

IITs are unsolicited clinical studies initiated and managed by nonpharmaceutical company researcher(s), including individual investigators, academic and community institutions, collaborative study groups, or cooperative groups. Dendreon’s IIT program aims to answer medical and scientific questions regarding sipuleucel-T, enhancing the understanding of its safe and appropriate application.

Investigators bear the legal and regulatory responsibilities of the trial sponsor for the conduct and management of the study, complying with applicable laws and regulations. Such obligations associated with the conduct of the study include, but are but not limited to, the following:

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IRB submission
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Subject enrollment and retention
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Safety report
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Data generation: study reports or publications
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Obtaining and maintaining an Investigational New Drug (IND) application, if applicable

Scope of Support

Dendreon may support IITs with funding, materials, and/or information, as allowed under local laws and regulations, provided that they align with the company-defined areas of strategic interest.

Eligibility

The proposed concept / idea should aim to improve treatment of disease, understanding of therapies, patient outcomes, and the quality of healthcare.

Types of IITs eligible for support, include, but are not limited to, the following:

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Combinations with other investigational or approved therapies: checkpoint inhibitors, poly-[ADP-ribose] polymerase (PARP) inhibitors, radiopharmaceuticals, etc
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Sequencing with androgen receptor targeted agents (ARTAs)
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Exploring the subsets (eg, based on genetic makeup or biomarkers) of patients with metastatic castration-resistant prostate cancer (mCRPC) who may obtain enhanced clinical benefits

The following are out of scope:

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Nonclinical studies (preclinical, real-world studies, etc)
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Compassionate use

How to Apply

Investigators requesting IIT support should complete the form below and upload the following documentation for review and consideration:

1.
A letter of request, including deadline for financial support
2.
Detailed proposal with total budget requested. Please include the expected starting date, duration of the study, name of the institution, and description of the study design
3.
W-9 form
4.
An itemized budget, with listed cosponsors, if any
5.
CV of investigator(s)

First Name*

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Please upload the following documents:

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A letter of request, including deadline for financial support*

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Detailed proposal with total budget requested.*

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W-9 form*

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Itemized budget (with listed cosponsors, if any)*

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Investigator's CV

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APPLICATION SUBMITTED

Thank you for your investigator-initiated trial application. A member of the Medical Affairs team has been assigned this case. Our Program Review Committee will respond within 30 business days. For a more immediate response, please email medicalgrantrequests@dendreon.com.