Fostering innovation beyond our walls

Overview

This program is open to all researchers who are interested in conducting their own clinical research. External investigators can collaborate with R&D experts at TESARO to develop clinical trials, and may receive compound and/or funding to support independent research activities.

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

Investigator Sponsored Trials are a type of external research where the Sponsor-Investigator 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 trials with TESARO products, here.

TESARO's Areas of Research Interest

  • Research in oncology disease areas which provides additional scientific information or fills existing data gaps in TESARO's existing portfolio
  • 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 an option to license inventions arising from the research to TESARO

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 trial website and reporting of serious adverse events
  • Analysis, reporting and publication of results

TESARO's 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 TESARO's medical and research strategy
  • Scientifically rigorous and capable of answering the trial 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

Timelines for Review

Clinical submissions are reviewed on a quarterly basis, as outlined in the table below.

Clinical Reviews Timeline

Investigator Concept Submissions

Rolling

Investigator LOI
Including Budget Estimate

December
15
March
15
June
15
September
15

TESARO Communication
of Decision

February May August November

Investigator Full
Protocol Submission

May
15
July
15
October
15
January
15

TESARO Protocol
Comments to Investigator

within 4 weeks of protocol submission

Revised Protocol
Submission by Investigator

within 3 weeks of receipt of comments


To request more information, send an email to externalresearch@tesarobio.com. Contact Janssen for niraparib prostate proposals.

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