Download should you take part in a clinical trial?

SHOULD YOU TAKE
PART IN A
CLINICAL TRIAL?
What You Need to Know About Clinical Trials.
Clinical trials are research studies to answer specific questions
about new medications, devices, diagnostic tools, genetic tests or
new ways to prevent diseases. Before a drug or other intervention
can be used or sold in the United States, it must be evaluated for
safety and effectiveness. Researchers use clinical trials to find out
whether an intervention is safe and whether it is effective.
Phase I:
The first phase, typically lasting around 18 months, tests the safety
of using the drug in humans and only enrolls a small number of
volunteers. Healthy people participate and tell researchers if they
experience side effects.
Phase II:
About 80% of new drugs are deemed safe and move on to Phase II.
This phase helps give an early indication of whether a drug will be
effective, and is designed to establish what test conditions will be
needed in Phase II to ultimately demonstrate a treatment’s
effectiveness. In particular, researchers decide on what the best
dose and timing of the treatment will be for the final phase of
testing. Phase II typically involves a few hundred patients and last
about two years.
Phase III:
About 45% of drugs pass Phase II and move on to Phase III. In
this phase, researchers compare the agent to the current standard of
treatment or a placebo, an inactive ingredient. This phase lasts 1-4
years and will ultimately determine whether the treatment is
effective.
Phase IV:
These studies bridge the gap between research and marketing.
This phase is designed to differentiate the drug from others in its
class, compare its efficacy against similar marketed compounds
and demonstrate health economic benefits in real world settings.
How We Protect Your Confidential Information?
Clinical trials may differ in how they protect confidentiality, but
some basic principals always apply:
• You will never be identified by name in any research
document.
• The FDA can inspect the medical records of participants in
clinical trials, but federal laws protect that information that
they gather during the trial.
• Unless otherwise specified, we never give information that
can identify you to anyone not involved in the clinical trial.
During the informed consent process, we will tell you how
research material will be handled. Typically, we use locked offices
and cabinets, and identify material by your assigned number, rather
than your name.
What Happens if I Want to Leave a Clinical Trial?
An important safeguard in a clinical trial is your freedom to leave.
You can leave a clinical trial at any time for any reason. The
informed consent that you sign does not force you to remain in a
trial. If you do leave the clinical trial, it may be helpful to let the
researchers know why you are leaving, although it is not required.
This information may help researchers improve the clinical trial
experience for other participants and make the results of the trial
more reliable.
Can I Be Forced to Leave a Clinical Trial?
Without trial participants, clinical trials fail and medical science
suffers. For these reasons, we make great efforts to help you
complete the trial. Before the clinical trial, you should clarify
exactly what is expected of you. Normally, only participants who
violate the clinical trial intentionally would be removed from the
trial. Occasionally, we might end your participation in a clinical
trial for other reasons. These include:
• Changes in your health that disqualify you, based on the
studies inclusion and exclusion criteria.
• Changes in your health that make the study more risky or
dangerous.
• A sponsor ends the clinical trials.
How Do I Get the Results of a Clinical Trial If I Choose to Join?
At the end of the clinical trial, you may ask for your results.
Researchers will not send results to anyone without your
permission, including your physician. To obtain the results of the
study it may take months or years dependent on the study.
Is There Reimbursement for My Participation?
Most clinical trials will reimburse you for your time and travel.
The more involved the clinical trial is the more reimbursement you
may receive. Payment is generally given at the end of the study. If
you choose to withdraw consent before the study is complete, your
payments will be prorated to the number of visits completed.
Thank you for taking the time to read about clinical research. We
look forward to your participation. If you have any questions or
are interested in finding out more information, please contact Britt
Pellinen at (860) 728-6740 or [email protected].
Information contained in this pamphlet is from the resources of:
• Savon Health, Spring 2005
• The Investigators Guide to Clinical Research, Center Watch
Publications, Second Edition
• An Introduction to Clinical Research, Self-Instruction Manual, Pfizer