Complete Heathcare for Women is quickly becoming a recognized Gynological research center.
We are actively engaged in a wide variety of clinical trials that are supported by major pharmaceutical
manufacturers and authorized and monitored by the Federal Food & Drug Administration. Participation
in medical research allows interested patients the opportunity to receive the most advanced and newest
treatments years before they become widely available.
What are Clinical Trials?
A clinical trial is a drug study sponsored by a pharmaceutical or biotechnology company. The purpose of
these studies is to find out whether a medication is safe to use and effective against various diseases or
medical conditions. In order to study the medication, several questions need to be answered first. For
example, what patient population or disease is the drug meant to treat? What criteria should be used for
accepting participants into the study? What general and disease-specific information are the study doctors
going to obtain?
Essentially, once these and other important study questions are answered, the study
doctors investigators) are chosen, the regulatory documents are approved, and the study is ready to begin.
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Why are Clinical Trials Important?
There are a several reasons why clinical trials are important. First, the
participant may have a positive response to the study medication, and their disease
or condition may improve. In addition, participants receive free laboratory and
medical testing. More often than not, the study medication is in development because
it works differently than other drugs on the market, and therefore, it may present
an alternative course of treatment for the patient.
Second, participation
in a clinical trial helps manufacturers make informed decisions about whether
to pursue getting a particular drug approved by the Food & Drug Administration
(FDA). Finally, data from one patient (who completes the entire study) can be
an important part of a drug development program. In the best-case scenarios, these
data can help get an exciting new drug approved by the FDA, and ultimately, continue
the industry's efforts in developing medications that are safer, more effective,
and work faster than any before them.
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How are a Participant's Rights and Safety Protected?
The FDA is the governing agency that develops
the policies and guidelines for all medical research, regardless of manufacturer,
study phase, or drug type. There are also independent Institutional Review Boards
(IRB) that review and approve all study-related documents, such as protocols,
Informed Consent forms, physician credentials and eligibility, and patient recruitment
materials, such as print advertisements and public service announcements.
How Can I Find Out About Clinical Trials?
If you are interested in taking part in a medical research project, or if you are a biotech or pharmaceutical company interested in
utilizing our world class facilities, please inform one of our physicians or study coordinators.
Contact Information
Complete Healthcare for Women
5910 Cleveland Avenue, Columbus, Ohio 43231
(614) 882-4343
(614) 883-4664 (Fax)
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