White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide – Chapter 6: Clinical Research and Investigator-Initiated Research
Chapter 6: CLINICAL RESEARCH AND
INVESTIGATOR-INITIATED RESEARCH
Supporting Legitimate Medical Research
Pfizer engages scientists, healthcare professionals (HCPs), research institutions, and academic
institutions to conduct research and development, including in vitro experiments (discovery), pre-
clinical animal studies, and clinical studies. Research sponsored by Pfizer, as well as research that Pfizer
supports that is sponsored by others, can generate important information about Pfizer products as well
as valuable medical and scientific information that can lead to improvements in clinical care, the
development of new treatments, and better delivery of healthcare to patients.
Pfizer-sponsored clinical studies are designed, conducted, overseen, and analyzed by Pfizer. Thus,
Pfizer is generally responsible for all of the regulatory obligations applicable to research and
development. Pfizer also provides support for studies designed and sponsored by outside investigators
or institutions, referred to as investigator-initiated research (IIR) studies. Pfizer may choose to
support IIR studies that advance medical and scientific knowledge and are of interest to Pfizer through
a grant, but Pfizer is not the sponsor of IIR studies. With limited exception, IIR grants may not support
studies that involve new product registration, a change in product labeling, or other regulatory efforts.
(See the section on Collaborative IIRs in Clinical Trial CMCD CT25 for additional information on using IIR
data for regulatory submissions.)
For many HCPs, conducting pharmaceutical company-funded medical research can be a significant
source of income. As a result, selecting an HCP to be a clinical investigator or to receive a grant for IIR
from Pfizer could raise significant issues under the healthcare laws if done for the wrong reasons.
Investigator-Initiated Research (IIR): a grant to support an investigator, institution or organization
(e.g., cooperative group, government agency or network) that will be the sponsor of a study that is
designed for the development of specific and defined medical knowledge. IIR support may be
provided in the form of funding and/or study medication.
Clinical Investiagor: a medical researcher who carries out a clinical trial or another type of clinical
research.
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