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:
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.
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:
The following are out of scope:
Investigators requesting IIT support should complete the form below and upload the following documentation for review and consideration:
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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 firstname.lastname@example.org.