What is a clinical trial or study?
This is a research study with human volunteers to answer specific health questions. It is the best way to evaluate drug effectiveness and safety in a controlled environment. The FDA requires all medications be tested before they can be prescribed by a physician.
How does a drug get approved by the FDA?
Drug Companies must spend a considerable amount of time and money evaluating new drugs on at least 2,500 people. New drugs must be proven safe and more effective than a placebo (sugar pill).
How much does it cost?
In most clinical trials, the study medication, testing, medical examination and consultation are provided at no charge.
Will I be compensated for my time and expenses?
Most trials do compensate participants for their time and effort.
What is informed consent?
This is the process designed to give volunteers the information they need before participating in a study. We discuss the requirements, risks, and potential benefits of the study and ask you to sign a document that records your willingness to participate in the study. We will answer all of your questions until you feel comfortable with your decision.
How long will the study last?
Every study has different requirements. Some studies can involve a single visit while others may involve many visits over several months.
What happens during a study?
This can vary greatly depending on the type of study being conducted. It may include lab work, physical examinations, EKG, Osteoporosis Scan, Cardiac Scans, Endoscopy, all at no charge. Symptoms, lab results and response to treatment are monitored very carefully. You will receive personal attention from our staff who will review all of your results with you.
Are clinical studies safe?
Volunteer safety is the number one priority for all clinical trials. Before a treatment is tested on people it is thoroughly tested using various laboratory techniques. The Food and Drug Administration has established rules to govern participant safety. An Institutional Review Board must approve study procedures before a clinical trial can begin.
What if I decide I no longer want to participate in the study?
Your participation is voluntary and you are always able to leave a study at any time. If you are having concerns about your participation, we would like you to contact your coordinator or other staff member to discuss your concerns as soon as possible.

 

Other Resources

Clinical Trial Information

Center Watch – Global source for clinical trial information
ClinicalTrials.gov
– Find trials for a specific medical condition


General Medical and Health Information

MayoClinic.com – health resources and medical information from the Mayo Clinic
National Institutes of Health
– health information from the Nation’s medical research agency
Web MD
– Information for better health


Cardiovascular Health

American Heart Association – heart health and disease information
Center for Disease Control and Prevention – heart disease resources


Celiac

Celiac.org – Celiac Disease Foundation


Diabetes

American Diabetes Association – comprehensive diabetes information
American Heart Association – general information
Women and Diabetes
– US Food and Drug Administration


High Blood Pressure

American Heart Association – general information
DASH Eating Plan – guide to lowering your blood pressure with the DASH eating plan
National Heart Lung & Blood Institute – risk factors, diagnosis, treatment, prevention, links


Gastrointestinal Issues (GERD, Ulcers, IBS, Constipation)

The American College of Gastroenterology – Up-to-date information and downloadable brochures
International Foundation for Functional Gastrointestinal Disorders – GERD resources
Irritable Bowel Syndrome Self Help and Support Group
– community for IBS sufferers

Gerd vs. Heartburn – article written by Dr. Krause
Understanding Irritable Bowel Syndrome – article written by Dr. Krause


ADDITIONAL INFORMATION: