1. What are the advantages of participating in a clinical study?
All clinical study participants receive quality medical care. You also help with
the development of safer and better medications for future generations.
2. How do you find out about
Information on clinical studies can be found by contacting us via phone, fax or
email. There is also a full listing of available studies found in the available
3. How does the FDA approve
The Food and Drug Administration (FDA) is charged with ensuring the safety and
effectiveness of all prescription medications marketed in the United States.
Before the FDA gives the medication manufacturer approval for marketing a given
medication, it considers two primary points: whether the clinical studies
provide substantial evidence that the medication is effective and whether the
medication is safe under the conditions outlined in labeling. Ultimately, what
the FDA considers is whether the benefits of the medication outweigh its risks.
For life-threatening diseases, the FDA has mechanisms to accelerate the approval
process so the treatment can be available to patients sooner.
4. What questions should I ask
before I agree to participate in a clinical study?
You have the right to ask any number of questions of the clinical study doctors
and sponsors prior to volunteering. Some questions may include:
Has this medication been tested on humans before? If so, to what extent?
What is the purpose of the medication?
What are the perceived risks?
Which company developed the medication?
How often will I be given the medication?
Will there be any invasive procedures carried out?
What is the samples type and how often will samples be taken?
How long does the trial last?
5. What does informed consent mean?
Informed consent refers to the process by which volunteer patients discover the
details of their clinical study. Participants must be provided all facts about a
trial prior to giving consent to participate, including treatment details and
possible risks and benefits. The informed consent form must be signed by
volunteers prior to participation. The informed consent process continues
throughout the clinical study.
6. How are clinical study participants protected?
Clinical study protocols are developed to ensure that participants are not put
at undue risk. These protocols are carefully reviewed by a committee of experts
and lay persons, called an Independent Review Board (IRB), before testing can
start. As a volunteer, you have the right to refuse treatment at any point in
the clinical study and to leave at any time and for any reason.
7. Where are clinical studies conducted?
Our studies are conducted in Overland Park, Kansas location of Quintiles at 6700
W. 115th Street. Clinical studies are typically held within a Phase I
unit - the facility in which the study is conducted. For Phase I, volunteers
stay within the unit throughout the trial and generally are not allowed to leave
the premises due to safety reasons.
8. What happens in a clinical
At its most basic level, a clinical study tests the effects of a potential new
treatment on participants. Some participants do not actually receive the test
treatment, but instead receive a placebo or standard treatment as part of the
"control" group. Your progress is followed closely by doctors.
9. Why should I consider
getting involved in a clinical study?
There are many individual and personal reasons for participation. Medications on
trial today could go on to become the licensed medications of the future, and
benefit you or family members. Some participants also enjoy the social
interaction with fellow volunteers and staff that they
experience while participating in clinical studies.
10. Will I be paid for
taking part in a clinical study?
Yes, you will be compensated for the time you spend with us. Compensation varies
by study and depends on time and type of study. We offer in-house and
out-patient studies, each varying in length.
11. How safe are clinical studies?
All trials contain some form of risk. We have been successfully conducting
trials for more than 25 years and have an excellent safety record. Our most
experienced experts review the trials and compounds to help enhance
12. What procedures are
involved in clinical study participation?
Typically we require blood and urine samples for analysis, but this may differ
from trial to trial. You should be provided with this information during the
informed consent process.
13. Can women participate in
Volunteer populations vary by study. We offer male only, female only, and mixed
population studies. Contact our recruitment line to check if any such studies
are currently available. You may also register to be informed of any studies you
are likely to be suitable for.
14. How long do clinical
Phase I studies can last anywhere from a few days to a few months. We also
conduct out-patient studies where periodic visits are required; these studies
usually take place over the course of a month or more.
15. Will I be tested for
nicotine, alcohol and recreational drug use?
Yes, these tests will be conducted at screening, check-in and randomly
throughout the course of a study. All results will be treated as confidential.
16. Will I be tested for HIV?
Yes. Results will be treated as confidential. However, the state must be
informed of positive results.
17. What do I need to do in
order to be considered for a clinical study?
Contact our recruiting department, steps to become a volunteer can be found in
our How Do I Volunteer Section. There is an application process you will go
through in order to be considered a qualified participant.
18. What happens at a clinical
You are provided with information about the study and a doctor will give you a
complete physical. Blood and urine samples will be taken and tested for
recreational drug and tobacco use. If your health status matches the criteria
for the study, you will be given the option to participate.