For Patients
Hoag is committed to leading the way in state-of-the-art technologies and
advanced treatment options. Part of this commitment involves conducting
groundbreaking clinical research with the goal of helping patients live
longer, healthier lives.
Through carefully planned clinical trials, researchers evaluate the safety
and effectiveness of new ways to diagnose, treat and prevent diseases
or conditions. Treatments studied in clinical trials might be new drugs
or new combinations of drugs, new surgical procedures or devices, or new
ways to use existing treatments.
Possible Benefits of Clinical Trials
There are many potential benefits for clinical trial participants. Patients
with existing diseases or conditions are able to take a more active role
in their own health care, gain access to newly researched treatments before
they are widely available, and help others by contributing to medical research.
Possible Drawbacks of Clinical Trials
New treatments being studied are not always better than, or even as good
as, standard care. They may have side effects that are unexpected, or
that are worse than those of standard care. As with standard treatments,
the new treatment may not work for you even if it works for other patients.
In addition, insurance companies do not always cover all patient care costs
in a study. What is covered varies by plan and by study.
If you decide to participate in a research study, you will be given contact
information in case of severe side effects or an emergency. If the treatment
you receive in the study turns out to be harmful, the study will be stopped.
Making an Informed Decision
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Informed consent: Before deciding to participate in a study, you will receive an informational
document called an Informed Consent Form. This form provides important
facts about the study to help you decide if participating is right for
you. Our research team will review this form with you and answer your
questions. Although you must sign the informed consent form in order to
participate in the study, it is not a contract. You may leave the study
at any time for any reason. Your study records are private and confidential.
Only the research team and your physician or nurse will have access to
your records.
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Risks and benefits: Every study is monitored to make sure it is as safe as possible. However,
all medical research involves some level of risk. The risks and benefits
vary depending on the particular study. To help you make an informed decision,
the research team is required to inform you of all known risks, benefits
and available alternative healthcare options.
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Ask questions: Whether or not to take part in a clinical trial is your decision. So
it’s important to take the time to fully understand the risks and
benefits of the study by asking questions. You may wish to bring a family
member or friend to help you ask questions and write down answers. For
more information, download the
FDA’s brochure.
Ensuring Clinical Trial Safety
Every clinical trial in the United States must be approved and monitored
by an Institutional Review Board (IRB). An IRB is an independent committee
of physicians, statisticians, community advocates and others whose objective
is to ensure that a clinical trial is ethical and the rights of study
participants are protected. The U.S. Food and Drug Administration (FDA)
audits the IRB files, and may visit research providers at any time and
review anything they choose related to clinical trials.
At Hoag, our clinical research team is committed to policies and practices
for ethical conduct of human research. Hoag has a tradition of excellence
in research and a continuing commitment to protect the interests and well-being
of patients. As such, Hoag strives to:
- Protect the interest and well-being of patients participating in clinical
research at Hoag Hospital
- Uphold regulations as set forth by the Federal Government concerning research
on human subjects
- Uphold the regulations set forth in the Nuremburg Code, International Conference
on Harmonisation (ICH) and the Belmont Report
- Uphold policies as set forth by Hoag Hospital
Review the
available clinical trials at Hoag now. For more information about available clinical trials nationwide, visit
centerwatch.com or
ClinicalTrials.gov.