Clinical Trials

What is a Clinical Trial?

A clinical trial is a research study that involves subjects to test new methods of screening, prevention, diagnosis or treatment of a disease.  A clinical trial is used to determine if an investigational drug or therapy is both safe and effective.  Clinical trials also determine new ways of using existing drugs or therapies and are carefully designed and monitored to ensure the safety of patient volunteers.  They are required by the Food and Drug Administration before a medication can be used by the general public.

Who can participate?

All clinical trials have guidelines about who can participate.  Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results.  The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that do not allow someone from participating are called “exclusion criteria.”  These criteria are based on factors such as age, gender, state of health and current condition, previous treatment history as well as any other criteria the specific pharmaceutical company imposes.  Before joining a clinical trial, a subject must qualify for the study.  Some research studies seek participants with illnesses or diseases to be studied in the trial, while others need healthy participants.  It is important to keep in mind that inclusion/exclusion criteria are not meant to reject people personally, but rather to select appropriate participants, keep them safe and ensure the researchers will be able to obtain answers to the questions they choose to study.

What happens during a clinical trial?

Study coordinators and physicians closely monitor the participants throughout the study via physical exams, laboratory tests and other medical procedures as mandated by the specific protocol.  Often, these procedures are in addition to what is normally done to manage the patient’s medical condition.  Patients in research studies can receive study related medications, tests and exams at no charge throughout the study.  Studies can last weeks, months or even years, during which time patients can save enormous amounts of money associated with traditional health care.

Are clinical trials safe?

Participant safety is always the number one priority during any study. Each candidate is given an informed consent form to read and ample opportunity to ask questions to completely understand the requirements of the trial.  The informed consent describes the most common risks associated with the medication being studied and the potential benefits of participating in the study.  Participation in a clinical trial is completely voluntary. Your medical condition will be closely monitored throughout the study against established parameters and you may choose to end your participation at any point in time for any reason.

Why should I participate?

Benefits of participating in a study may include:

• Gaining access to new medications that otherwise are not yet widely available
• Access to individualized medical care without the enormous expense
• Opportunity to learn more about your medical condition
• Receiving study related medications, medical care, supplies and laboratory services at no cost
• Knowledge that you are helping others and contributing to the advancement of medicine
• You may be compensated for your participation time and travel expenses

What can I expect at my first visit?

Each study varies in what procedures are completed at the first visit.  You may expect the following to be conducted to see if you qualify for the research study:

• Informed Consent Form
• Medical history interview
• Review of current medications
• Vital signs
• Physical exam
• Questionnaires

Depending on the study, you may also sometimes need blood or urine tests.

Your visits will vary in the amount of time they might take.  The first task you will complete is to read and sign the Informed Consent Form.  This will tell you why the study is being conducted, what will happen at each visit, risks and benefits, confidentiality, and alternative treatment options.  You will be given ample time to read over the form and ask questions.  You will need to be able to read the form yourself.  Therefore, please bring with you any items you may need for reading and discussing the form such as reading glasses, hearing aides, etc.

Properly preparing will help us make your visit faster and more enjoyable.  If you have any questions regarding an upcoming study visit, please contact a member of our clinical research team at (602)971-0268.

Current Studies

At this time there are three separate clinical research opportunities for which we are recruiting appropriate subjects:

Protopic Study:  A long term pediatric study of the safety of Protopic Ointment for

patients with Atopic     Dermatitis

• Participants must have been under the age of 16 at first use
• Participants must have used Protopic for at least 6 weeks
• Participants (parents) must be willing to answer questionnaires every six months either by phone or mail
• Participants must have annual physicals and every 2 years skin exams