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INVESTIGATOR-SPONSORED RESEARCH

Fostering innovation beyond our walls

Overview

Our growing pipeline includes compounds that selectively target cancer cells and enhance immune response. We focus on cancers with unmet clinical needs. External investigators can collaborate with R&D experts at TESARO to develop clinical studies, and may receive compound and/or funding to support independent research activities. This program is open to all researchers who are interested in conducting their own clinical research.

  • Interventional research may be considered after there is a recommended phase 2 dose and schedule from the TESARO-sponsored development program
  • Observational research includes epidemiology studies, assessment of current clinical practices, and/or patient-reported outcomes

Investigator-Sponsored Research is a type of external research where the Investigator-Sponsor independently proposes research. The Investigator or Institution serves as the study Sponsor and assumes responsibility for designing the study, directing the research conduct, including the administration of study drug, ensuring compliance with all local laws and regulatory requirements, and analyzing and communicating any study results.

Visit clinicaltrials.gov for a list of external studies with TESARO products.

Areas of Research Interest
  • Research in oncology disease areas that provides additional scientific information or fills data gaps in the existing portfolio of TESARO
  • Expansion in the understanding of expected risks and side effect management
  • Innovative combinations with strong scientific rationale
  • Identification of predictive biomarkers for patient selection or stratification
  • Patient-reported outcomes research
Researcher Requirements
  • You are qualified by training and experience to undertake the proposed research and have a current medical license, if necessary
  • The idea is yours and the research materials will be authored by you
  • You are not seeking funding for research that would otherwise be paid for by your institution
  • You have the ability to grant TESARO an option to license inventions arising from the research
Researcher Responsibilities
  • Design and execution of the research with timely communication of results to TESARO
  • Compliance with all local laws and regulatory requirements
  • Public registration on a clinical study website and reporting of serious adverse events
  • Analysis, reporting, and publication of results
Our Review Criteria
  • Designed to address a legitimate medical or scientific question related to the use of a TESARO product, product candidate, or disease area of interest
  • Aligned with medical and research strategy of TESARO
  • Scientifically rigorous and capable of answering the study or study hypothesis
  • Conducted by a qualified investigator at a facility with appropriate experience conducting research activities
  • Designed to meet ethical guidelines concerning human subjects in research

GLOBAL CLINICAL SUBMISSION PORTAL

To request more information about our global clinical submissions, email externalresearch@tesarobio.com. For niraparib prostate cancer proposals, please contact Janssen.

Request a visit from your local Medical Science Liaison or Scientific Advisor.