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MPD clinical trials: What you need to know
What is a clinical trial?
What is the purpose of a clinical trial?
Why participate in a clinical trial?
Things you should know about participating in a clinical
trial.
Useful questions to ask before participating in a clinical
trial.
What
is a Clinical Trial?
By
definition, a clinical trial is a comparison test of a medication or other
medical treatment (such as a medical device), versus a placebo (inactive
look-a-like), other medications or devices, or the standard medical treatment
for a patients’ condition. The number of patients can range
from as few as 30 to hundreds or thousands. There are two kinds
of clinical trials:
Observational - Participants are observed by researchers
as to their outcomes
Interventional - Participants are assigned a treatment
as researchers observe their outcomes
The
ethical and legal codes that govern medicine also apply to clinical trials.
There are many checks and balances in place to ensure the safety of clinical
trial participants and the study plan is thoroughly vetted before testing
in human subjects is allowed.
What
is the purpose of a Clinical Trial?
To
assess the safety and effectiveness of a new medication or device
on a specific patient
Assess
the safety and effectiveness of a different dose of medication
than is commonly used
Assess
whether the new medication or device is more effective for
the patients’ condition than the already used, standard medication
or device
Compare
the effectiveness in patients with a specific disease of two
or more already approved or common interventions for that disease.
Why
participate in a clinical trial?
Help medical science to advance
treatments and better understand disease
Trials
make new research treatments available to participants
before they are widely available or fully approved
Help researchers test treatments and observe
the outcome for disease in a diverse patient population.
This is important so scientists understand how a disease works within
different demographic groups (like gender, age, race). This also
affords the researchers the ability to observe differences in reaction
among patient groups to new treatments options. Click
here to learn why diversity in clinical trials is important.
Some
things you should know about participating in a MPD clinical trial:
It
is important to meet with your hematologist to decide whether
a MPD clinical trial exists that is appropriate for your stage of disease,
and whether the logistics of participation with that specific trial
works for you.
All MPD clinical trials have
guidelines about who can participate. These Inclusion / Exclusion
criteria vary for each trial, and are based on factors such as age,
gender, the type and stage of a disease, and other medical conditions.
Your hematologist can help you determine whether you are qualified for
the study.
The process of Informed Consent occurs
before during and after participation in a clinical trial. Study
details (including risks and potential benefits) are explained
by doctors and nurses and are also provided in writing. If your
native language is not English translations are available.
As you are taking this step be prepared to be actively involved
in the process. Jot down any questions you have and visit
the clinic or investigation site prepared to take notes. Feel
free to bring a tape recorder with you.
There could be costs involved which may or may not
be covered by your insurance. Be sure to check with your doctor,
the researchers and your insurance when considering the financial ramifications.
Useful questions to ask before
participating:
What
is the purpose of the study?
Who
is going to be in the study?
Why
do researchers believe the experimental treatment being tested may be
effective?
Has
this been tested before?
What
kinds of tests and experimental treatments are involved?
How
do the possible risks, side effects, and benefits in the study compare
with my current treatment?
How
might this trial affect my daily life?
How
long will the trial last?
Will
hospitalization be required?
Who
will pay for the experimental treatment?
Will
I be reimbursed for other expenses?
What
type of long-term follow up care is part of this study?
Will
results of the trials be provided to me?
Will
my current physicians (hematologist/primary care) be made aware of the
results?
Can
a participant leave a clinical trial after it has begun?
A full roster
of clinical trials is available at clinicaltrials.gov by clicking here
(you will be redirected away from mpdfoundation.org)
Some
of the information herein was taken in part from clinicaltrails.gov.
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