Healthy Skepticism Library item: 15461
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: report
Abstract:
Table of Contents
Preamble ……………………………………………………………………..1
Commitment to Protecting Research Participants ………………5
Conduct of Clinical Trials ………………………………………………7
Ensuring Objectivity in Research……………………………………13
Providing Information About Clinical Trials …………………. 19
Q & A ……………………………………………………………………….27
Preamble
The Pharmaceutical Research and Manufacturers of
America (PhRMA) represents research-based pharmaceutical
and biotechnology companies. Our
members discover, develop, manufacture and market new
medicines and vaccines to enable patients to live longer and
healthier lives.
The development of new therapies to treat disease and
improve quality of life is a long and complex process. A critical
part of that process is clinical research, the study of a
pharmaceutical product in humans (research participants).
Clinical research involves both potential benefits and risks to
the participants and to society at large. Investigational clinical
research is conducted to answer specific questions, and some
aspects of the therapeutic profile (benefits and risks) of the
product(s) tested cannot be fully known without study in
humans. In sponsoring and conducting clinical research,
PhRMA members place great importance on respecting and
protecting the safety of research participants.
Principles for the conduct of clinical research are set forth in
internationally recognized documents, such as the Declaration
of Helsinki and the Guideline for Good Clinical Practice of the
International Conference on Harmonization (ICH). The prin-
•1•
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ciples of these and similar reference standards are translated
into legal requirements through laws and regulations enforced
by national authorities such as the U.S. Food and Drug
Administration (FDA). PhRMA members have always been
committed, and remain committed, to sponsoring clinical
research that fully complies with all legal and regulatory
requirements.
Many different entities and individuals contribute to the safe
and appropriate conduct of clinical research, including not
only sponsoring companies but also regulatory agencies; investigative
site staff and medical professionals who serve as
clinical investigators; hospitals and other institutions where
research is conducted; and institutional review boards and
ethics committees (IRBs/ECs).
PhRMA adopts these voluntary Principles to clarify our members’
relationships with other individuals and entities involved
in the clinical research process and to set forth the principles
we follow.
The key issues addressed here are:
• Protecting Research Participants
• Conduct of Clinical Trials
• Ensuring Objectivity in Research
• Providing Information About Clinical Trials
•3•
These Principles reinforce our commitment to the safety of
research participants, and they provide guidance to address
issues that bear on this commitment in the context of clinical
trials that enroll research participants and are designed, conducted
and sponsored by member companies.
For purposes of these Principles, a “clinical trial†means an
interventional trial involving human subjects from Phase 1
and beyond. For example, the term does not include the use
of a drug in the normal course of medical practice or non-clinical
laboratory studies.
These revised Principles take effect on October 1, 2009.
