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The following press release provides insight on industry trends
and behaviors impacting all players involved in clinical research
as analyzed and reported by CenterWatch.
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FOR IMMEDIATE RELEASE
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CONTACT:
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CenterWatch Launches First-of-its-Kind Consumer Guide To
The Risks and Benefits of Volunteering for Clinical Trials
New Book Empowers Volunteers To Make More Informed Decisions
Before Consenting to Participate in a Clinical Trial
BOSTON - April 11, 2002 - CenterWatch, the leading publisher
of clinical trial news and information, today announced the
release of "Informed Consent: The Consumer's
Guide to the Risks and Benefits of Volunteering for Clinical
Trials". This groundbreaking new book provides patients
and their advocates with comprehensive and balanced facts, information
and resources that help them understand the research process,
their rights as volunteers, how to find and take part in clinical
trials, and what questions to ask.
Last year, more than 17 million people inquired about participating
in clinical trials in the US, and more than two million people
volunteered for industry- and government-sponsored studies.
The growing number of participants in our nation's clinical
trials last year is indicative of a trend where consumers are
becoming more receptive to considering investigational treatments
as part of their medical options. Yet, identifying and evaluating
whether to participate in a clinical trial can be frightening
and confusing for consumers. To date, there has been nowhere
for patients to turn to help them fully understand what they
need to know to make educated and informed decisions and to
understand their rights as research volunteers.
"My personal experience in losing a son in a gene therapy
trial exposed many very serious flaws in the informed consent
process. This book informs the average human being about what
to expect and ask when participating in clinical research. It
is a book long overdue," said Paul Gelsinger in his Foreword
to the new CenterWatch book.
CenterWatch's CEO Kenneth Getz and health writer Deborah Borfitz
spent more than four years developing Informed Consent.
Getz and Borfitz co-authored the guide based on extensive research,
expert commentary and interviews with research and regulatory
professionals, patient advocates and consumers.
Deborah Borfitz, said, "When faced with a debilitating
or life-threatening illness, 85 percent of patients and their
support networks want to know more about clinical trials and
investigational treatments. But an equal percentage say that
their primary and specialty physician or nurse do not provide
them with any information on clinical trials."
More than 80,000 clinical trials are conducted in the United
States annually. There may be excellent opportunities for patients
to find promising and potentially life-saving new treatments.
However, whereas the majority of clinical trials are safe and
effective, there are risks for volunteers. A CenterWatch analysis
of FDA data found that one in 30 volunteers typically experience
a serious side effect, and one in 10,000 die due to the effects
of the study drug.
Added Ken Getz, "Reviewing study requirements and signing
an informed consent form is an important first step before volunteering
for a clinical trial. However, it's extremely important that
patients and advocates take it upon themselves to seek out additional
information about a clinical trial and to fully understand the
specific benefits and risks, and their rights and recourse as
a participant. With "Informed Consent"
we hope to empower consumers to become far better educated and
to take more control."
Informed Consent provides an authoritative and
balanced foundation that empowers patients, their family and
friends to understand what to ask, how to identify and minimize
risks, and where to go for more help when considering volunteering
for a clinical trial. Specifically, the guide covers topics
including:
- Your rights as a volunteer, and how to protect them
- How to determine if a clinical trial is right for you
- How to find and evaluate clinical trials
- Special considerations for vulnerable populations including
children and the elderly
- What to do when things go wrong
- A useful and practical appendix of reference information
Informed Consent will be distributed through a
variety of channels including major retail and online stores,
health associations and academic institutions, government agencies,
patient advocacy groups and medical societies. Pharmaceutical
companies will also be distributing the guide. CenterWatch will
offer copies of the book through www.centerwatch.com.
About CenterWatch
CenterWatch is a Boston-based information services company that
focuses on the clinical trials industry. CenterWatch offers
a variety of publications and services for clinical research
and general health professionals, patients and health consumers.
Along with disease specific reports and profiles of centers
that conduct clinical trials, CenterWatch publishes a variety
of searchable databases online including directories of several
thousand drugs in clinical trials, drugs recently approved by
the FDA, and clinical trial results. In addition, the CenterWatch
web site lists more than 42,000 ongoing clinical trials seeking
volunteers. An estimated eight million people will visit the
CenterWatch web site at www.centerwatch.com
to view these trial listings. CenterWatch is a subsidiary of
Thomson Healthcare, publishers of the Physicians Desk Reference
®.
To order a copy of Informed Consent: The Consumer's
Guide to the Risks and Benefits of Volunteering for Clinical
Trials, please go to www.centerwatch.com
or call 1-800-765-9647.
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