CLINICAL IISR REQUESTS

What is a Clinical IISR study?

Clinical Investigator Initiated – Sponsored Research (IISR) study is an unsolicited clinical study, outcomes or disease related research in which the investigator independently generates a research proposal and for which Millennium provides financial, drug, and/or in-kind support. The investigator or the institution the investigator is affiliated with serves as the Sponsor. The Sponsor is responsible for initiating and conducting the study, directing the administration or dispensing of study drug (if applicable), ensuring compliance with all local laws and regulatory requirements, as well as the analysis and communication of all study results.

IISR studies are also commonly referred to throughout the pharmaceutical industry as Investigator Initiated Research ("IIR"), Investigator Initiated Studies ("IIS"), Investigator Initiated Trials ("IIT"), and Investigator Sponsored Trials ("IST").

Why does Millennium Support Clinical IISR studies?

Millennium's objective in supporting Clinical IISR studies is to obtain valuable scientific, clinical and outcomes information relating to Millennium products or disease states of interest and to enhance patient care. Millennium supports legitimate programs in a manner consistent with all applicable regulatory requirements and ethical standards.

Millennium's Clinical IISR program serves to:

  • Facilitate independent research via a transparent, understandable, and efficient process
  • Identify emerging research trends and fulfill unmet needs for new scientific data to help advance the knowledge of a specified therapeutic area
  • Explore the feasibility and viability of new scientific ideas of interest through pilot studies

Investigators are accountable for meeting Clinical IISR goals as outlined in the study agreement, including manuscript development.

Millennium's Online Request System

Millennium provides an online system for the management of Clinical IISR proposals. This system enables investigators to view real-time information and perform tasks related to their particular IISR study including, but not limited to:

  • Submit a Clinical IISR proposal
  • Track study enrollment/progress
  • Monitor payment history
  • Close out the study

Millennium's Clinical IISR Review Committee

Millennium has established an internal review committee to evaluate Clinical IISR proposals. The review committee is comprised of internal representatives from clinical research, legal, regulatory, medical affairs and regional affiliates. The committee bases its decisions on scientific merit, safety, feasibility, alignment with Millennium's clinical strategy and compliance with legal, regulatory, and ethical standards.

Please be aware that support is awarded strictly based on research merit criteria. Millennium's decision to support external research is not influenced by the use, purchase, prescribing, or recommending for prescribing of any current or future Millennium product.

Visit the Clinical IISR Request System