A Doctor/Investigator...

Aside from your doctor's private practice he/she may also be an investigator for medical research studies. As an investigator, doctors take a step to help medical science discover and/or improve current medications. Investigators are compensated for their services as well as research volunteers are compensated for their time and transportation expenses during the course of the study participation. The terms and conditions are usually discussed during the screening period.

Whether you have been referred by your doctor or found us by other means, the following information has been compiled to give you an overview about volunteering in a research study (also know as a clinical trial).

Frequently asked questions include...

What is a Research Study?

A research study (also known as a clinical trial) is a study in which people volunteer to test a new medical treatment. By conducting research studies, we learn whether new medications are safe and effective. Also, currently approved medications may undergo testing for the treatment of new indications. Research studies are needed to develop new medications for many conditions, including: high blood pressure, arthritis, migraine’s, reflux, diabetes, insomnia, Alzheimer’s, etc. Once a new drug is found to be safe and effective, it may be approved by the FDA for doctors to prescribe.

Why should you join a research study?

You can gain access to new research treatments and help others by contributing to medical research.

Who can participate in a research study?

All research studies have certain requirements which must be met for eligibility. These requirements may include factors such as age, gender, type of disease, current medication use and other medical conditions.

How does a research study work?

Research studies are supervised by qualified doctors and researchers who work as a team with other doctors, nurses and health care professionals. If you are interested in participating in a clinical trial you will meet with someone from the study team who will explain and discuss the study with you. If after the discussion you want to participate in the study, the study team member will give you an informed consent document to read and sign.

The informed consent describes what you can expect from your participation in the study such as the frequency of the study visits, what procedures will be done during the study, any potential benefits and possible risks of participating in the study. It is very important that you take your time and read the informed consent document carefully. If you have any questions regarding the document, you should discuss them with the study doctor and study coordinator. Once you are satisfied that you understand all of the information given to you and that all of your questions have been answered, you will be asked to sign the informed consent document. After signing the informed consent, information will be obtained from you to see if you meet the requirements for study enrollment. Once eligibility is confirmed you will be enrolled in the study.

You should note that different studies have different requirements, but generally during the study you can expect:

• To be assigned to a group that is given the study drug or to a group that is given a
   placebo (an inactive product, like a sugar pill)
• Your medical history to be reviewed
• To have a physical exam
• To have your blood drawn for study specific tests
• To be asked to complete several study visits
• Your health to be checked throughout the time you are in the study

What questions should I ask?

It is important that you know as much as possible about the clinical trial so that you can make an informed decision as to whether or not you want to participate.

Here are some questions you may want to ask:

• What is the purpose of this research study?
• How long will I be in the study?
• What kinds of tests and procedures are involved in the study?
• Is there a chance I will receive a placebo (inactive substance)?
• Can I leave the study at any time?
• Will my records be kept confidential?
• How do the risks, side effects and benefits in the study compare with the current treatment?
• Are there alternative treatments available?
• Who will pay my medical bills if I am injured during the study, and who should I
   contact if I am injured?

The answers to these questions can also be found in the informed consent. When considering whether or not to participate in a research study, you may request a copy of the informed consent for your review and to discuss with your physician, family and friends.

Are research studies safe?

Researchers, doctors, and other health professionals conduct research studies according to strict rules set by the Food and Drug Administration (FDA). The FDA created these rules to protect clinical trial participants and to make sure they are treated as safely as possible. research studies are also overseen by medical ethics groups to ensure that study participants are treated appropriately.

What are the benefits of participating in a research study?

By participating in a clinical trial you will get study related materials and medical care during the trial, have access to new research treatments, and help others by contributing to medical research.

Can I leave a research study once it has begun?

Yes. You are free to leave the trial at any time. If you do decide to leave, you should let the study team know and tell them why you are leaving the study. Early study termination procedures will be done to ensure your safe exit from the study.

Where can I get more information about research studies?

There are several organizations that offer information about research studies. Here are a few:

- Center for Information & Study on Clinical Research Participation (CISCRP): Web: www.ciscrp.org  
- ClinicalTrials.gov – Their website address is
www.clinicaltrials.gov
- CenterWatch: Their website address is
www.centerwatch.com   





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