The Importance of a Professionally-Managed Investigator Sponsored Trial (IST) Program
An IST, sometimes referred to as an investigator-initiated study (IIS) or investigator-initiated research
(IIR), is research study in which the principal investigator (PI) conceives the research, develops the
protocol, and serves as sponsor-investigator. ISTs have been wildly popular in recent years and
significant investments are made by Pharma to ensure the programs are organized and well-funded.
Most sophisticated pharmaceutical and device companies have dedicated IST operations teams since
these programs offer a rich source of real-world evidence over traditional investigational new drug
(IND) methods. Overseeing the activation and support for these investigations is therefore a critical
function of Medical Affairs departments.
Investigator sponsored research aims to address important scientific questions while maintaining a
rigorous scientific design, alignment with good clinical practice and respecting the privacy and safety
enrolled patients. ISTs, when completed on time and with proper guidance from the collaborator, may
provide valuable insight into the potential applicability of a drug which would otherwise not be
considered for clinical development. ISTs are meant to be proof-of concept projects and should not be
used exclusively for label expansion or for exploiting off-label uses. IST operations therefore provides
oversight to ensure important responsibilities are managed by the PI including ethics and regulatory
approvals, registration in trial registries, data ownership and processing, review of manuscripts and
dissemination of results, reporting obligations to the manufacturer, payment schedules, and intellectual
property oversight. Studies must be conducted without significant direction from the collaborator, and
proposed investigators are required to secure agreements with the collaborator that define the scope of
the support and to ensure compliance with applicable laws and regulations.
It is important that IST operational activities, including approval and funding decisions, rarely overlap
with or engage field-based MSL teams since this can have the appearance of enticement or off-label
promotion, impose significant compliance implications, and expose the company to unnecessary
liabilities. Maintaining distinct workstreams promotes MSL neutrality and maintains the veil of
impartiality and safe harbor that MSL teams enjoy when operating compliantly outside of approved
labeling. The IST process should also ensure proper data repository methods and maintain strict
oversight of incoming proposals. Costly legal repercussions can arise from a company’s lack of proper
documentation if, for example, they reject an investigator’s proposal but fail to appropriate track and
document the request since the investigator may claim legal rights to any intellectual property arising
from subsequent company-sponsored research.
Fully organizationally-integrated IST teams are better able to evaluate new proposals and expedite
their execution. A cross-functional review streamlines the path to approval and also allows the IST
teams to select the most viable proposals. Integrated IST departments should include partners in
Medical, Research and Development, Marketing, Finance, Legal and Regulatory teams. Poor oversight
of IST data dissemination can potentially lead to incongruent interpretation of the company’s sponsored
clinical studies. By establishing a formal IST management process that engages multiple internal
departments, companies can measure the progress of their efforts with defined performance indicators
including IST capacity, the number of studies proposed, research milestones and publication metrics.
In today’s complicated regulatory environment it is foolish to haphazardly disperse funds or supply
drugs without a structured operational team in place that conforms to a company’s SOPs and considers
the implications of the proposed research. Effective IST management should therefore include both
operational and strategic components that ensure approvals are based on corporate and product-
specific strategies. Established IST management ensures that committee decisions follow procedures
set forth in SOPs, tracks study progress, serves as a troubleshooter during IST execution, and
facilitates the integration of results with cross-functional teams.
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