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Frequently Asked Questions for Volunteers
What
does PRACS do?
PRACS is contracted by pharmaceutical companies to evaluate their human
drug products and determine if the product meets FDA standards. If it
meets FDA requirements, then the company can sell their product to the
U.S. consumer.
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How does PRACS evaluate drugs?
Evaluating these pharmaceutical products (drugs) typically requires recruiting
healthy persons to take one or more doses of a drug and then collect blood
or urine and/or fecal samples over a defined period of time. The collected
samples are evaluated on very sensitive instruments to determine the amount
of drug in each sample. That drug data is evaluated to determine the amount
of drug absorbed and eliminated by the study participant.
This relatively
simple study design is used to evaluate both new and old drugs. Therefore,
we could be evaluating how a new brand name drug is absorbed or we could
be evaluating a generic drug to determine if it matches the current brand
name drug. For the new or brand name drugs, we typically know how the
drug works before we participate in evaluating how a particular tablet
or capsule is absorbed. For brand name drugs, we sometimes evaluate new
ways to give a drug to patients. For instance, the sponsor may be interested
in developing a once a day dose rather than the current 3-4 times a day
dosing. For our generic drug studies, it typically means the 20 year name
brand patent is about to expire and a generic company wants to develop
their ‘me-too’ version of the drug. In both of these study
designs, the number of subjects, the screening activities, the number
of blood collections and the general design is about the same. Study design
and the number of blood draws will probably vary because of the duration
of time different drugs (such as aspirin vs. ibuprofen) stays in the body.
Remember, there can be no difference between a generic or brand name drug.
Some studies require we recruit patients with certain medical problems
to determine if a new product works as well or better than current drugs.
For example, if a company has a potential new blood pressure or migraine
medication, we will recruit patients with those disorders to determine
if the new product is equal to or better than current medications. Those
studies are similar to your usual health care routine. To explain, there
are no overnight stays at PRACS, only routine visits, just like visiting
your home physician, to determine how well the product is working on your
disorder. The only difference between those research study visits and
your home physician is we have a set regimen of activities at each visit.
For example, for blood pressure studies, we may take you blood pressure
at each visit laying down, sitting and standing. This is a bit more than
you home physician would do, but we need to fully understand this new
medication … so, we have more checks and balances than routine healthcare.
Does
anybody review PRACS studies?
PRACS, just like any research medical center or university, must receive
approval from our independent Institutional Review Board, (IRB) before
initiating projects. This is an FDA requirement for research. The IRB
members are local volunteers whose sole purpose is evaluate the risk versus
benefit of each drug study. To explain, they very are interested in is
the safety of our participants. The board members consist of people in
the medical field, clergy, university faculty, and lay persons and not
PRACS employees. They have full veto power over any PRACS project and
have full information on all activities within PRACS jurisdiction.
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Are
the studies safe?
First of all, one must assume there is no such thing as a totally safe
drug. From that perspective, PRACS gives the highest regard to subject
safety and FDA standards. Therefore, if we assume there is any possible
risk or concern for subject safety or subjects violating food and drink
requirements, you will be confined to PRACS and under the observation
of our trained staff.
Any drug, including aspirin, can have unpleasant effects such as an upset stomach. At PRACS, we try to we educate, evaluate, and monitor our study participants carefully to minimize problems. For example, we usually only give one dose of drug per study period. Since we are most frequently evaluating generic drugs that are currently available to patients in Fargo-Moorhead and throughout the U.S., we know what kind of effects to expect. Typical side effects or adverse events include stomach upset, drowsiness, headache, or dizziness. We collect blood samples until we know the entire drug is completely out of your body. Therefore, you should not expect any long-term good or bad effects.
But remember, as with any prescription drug, there is always a risk!
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How
do I get into a study?
You can start by giving our recruiting staff a call and selecting the
dates that will work best with your schedule. You will then be set up
for a screening appointment. The screening appointment takes about one
hour and usually involves filling out a medical history, a medication
history, completing an ECG, (which monitors your heart), giving us blood
and urine samples, and having your blood pressure checked. You will also
receive indepth information on your study of interest during the visit.
The lab samples collected provide us with general information on your
heart, liver, lungs, and kidneys. The intent is to determine if those
organs appear to be functioning properly. If your organs are functioning
properly, then you should absorb and eliminate the drug properly. For
example, your urine sample allows us to check your kidney function as
well as screen for drugs of abuse. Either during screening or shortly
thereafter, you will be scheduled for a brief physical examination by
our physicians to determine if you are in generally good health. All of
these services are provided at no cost to you. If you pass all of these
evaluations to the satisfaction of the physicians, you are then eligible
to participate in the study. This does not guarantee you will be placed
in a study!
If
I pass my screening, will I be used in the study?
There are no guarantees. We always have to screen a few extra people
for each study to ensure we will have enough qualified participants. If
you check in for a study and are not chosen to participate in your selected
study, you will be sent home after an overnight stay. Likewise, if you
checked in for a study and almost qualified or if you were one of the
extras, we will send you a partial honorarium or check to pay for some
of your time and trouble. If you are one of the extras, and therefore
excused from study participation, you will have priority status for the
next study of mutual interest.
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What happens in a study?
In a typical study, you may have two overnights at PRACS and one full
day of study activities for each study period. For example during one
study period, you might check into the PRACS facility on a Friday evening
at approximately 8:00 PM for an overnight stay. Saturday morning you will
be awakened at approximately 6:30 AM in preparation for the day’s
activities. You will receive a single dose of the drug being tested followed
by 17 to 20 blood draws over the next 24 to 48 hours. We need you to stay
at PRACS during the study. All meals and sleeping quarters are provided.
Studies typically run from Friday evening through Sunday morning, or Saturday
night to Monday morning. After completing the first weekend, you will
typically be required to repeat the entire process (Period 2) the following
weekend using the other or comparing drug. Some studies are scheduled
during the week or over multiple days. About 55% of our studies require
two separate study periods, 25% may require four study periods (for example
four consecutive weekends) and the balance may require multi-day or other
variations.
What
should I bring to the study?
You will need to bring blankets or sleeping bag and a pillow. Sheets,
towels, and washcloths are provided. You should also bring your personal
hygiene items, (toothbrush, toothpaste, shampoo, hair conditioner, etc.)
You are welcome to bring some leisure items such as books, board games,
video games, or study materials. We have cable TV, DVD movies, and a variety
of cards and games available for your use. You are NOT
allowed to bring any gum, candy, food, or medication with you to the study.
When
do I get paid?
You are paid after completing the study which includes all periods, any
return blood draws and the exit physical exam, if one is required. The
exit labs and physical exam assure everyone that you came into the study
a healthy person and you are leaving the study as a healthy person. This
provides a comfort level for you as well as the sponsor of the study.
Remember, sick persons handle drugs differently than healthy persons,
so we need to know if you developed a common cold or other illness. If
you complete only part of the study, the amount you are paid will be pro-rated.
What
do we have to eat during a study?
The meals for studies are prepared to meet study requirements. Therefore,
if you have fussy or selective or vegetarian eating habits, we would advise
you to not screen for our overnight studies. During the overnight studies,
our diet is very restrictive and cannot be varied to accommodate your
eating habits. In addition, if it is a required breakfast study of fried
eggs, bacon and/or toast, we cannot vary the breakfast and you must eat
all of the breakfast to satisfy FDA requirements. We apologize for the
inconvenience.
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