A Patient's Guide to Liver Clinical Studies
California Pacific Medical Center
The search for more effective liver disease and gastroenterology treatments continues to gain momentum, with California Pacific's Hepatology and Gastroenterology Research Program at the forefront of advances and research. We offer multiple research trials using groundbreaking medications and procedures that can have life-extending or life-saving implications.
Because our research efforts are integrated with our Liver Disease Management & Transplant Program, patients benefit by having the same physician team delivering their medical care, with tests and examinations organized for the patient's convenience.
Participating in clinical research gives you access to new treatments that may or may not be better than those already available. Study participants are an integral part of the research process and without participants' involvement, medical advances would not be possible.
What is a Clinical Trial?
All new drugs go through extensive testing by the Food and Drug Administration (FDA) before they can be marketed in the United States. A clinical trial is the study of the drug in human volunteers. Clinical trials test a medication's efficacy and safety. Clinical research centers, places in which these trials are carried out, help pharmaceutical companies make these important new medications available to the general public.
In addition to investigating new medications, clinical research centers also examine the spread of a disease in different populations, one's quality of life with a particular disease, and alternative medical procedures. These study results give physicians greater insight into the disease and possible treatments.
This is Where You Come In
The clinical research centers — such as California Pacific Medical Center — are responsible for finding volunteers to take a medication and report its effect. This is a critical part of the clinical trial process. These medications have already undergone extensive testing required by the FDA to make them as safe as possible for use in all clinical trials. Research centers also need volunteers to undergo examinations or complete questionnaires that will help provide background into a particular disease, such as hepatitis.
Are Clinical Trials Safe?
Patient safety is the utmost concern of pharmaceutical companies, the FDA and California Pacific Medical Center. Precautions are taken to ensure the study participant understands and agrees to the study. Before participating, volunteers must read and sign an informed consent that provides detailed information regarding the medications, the study and its risks, and specific procedures that will take place.
Experienced clinical research physicians and clinical research coordinators closely monitor each participant during the course of a study. An IRB (Institutional Review Board) carefully reviews all research studies before they begin and throughout the course of the trial. This board consists of medical professionals and ethicists representing the community. The IRB has the study participant's best interest in mind. They will raise questions and/or concerns if needed.
Can I Still See My Doctor?
Yes. You should continue to see your regular physician for all your medical needs. Your physician will be informed of your progress in the study. A better lifestyle for you is the number one goal for us.
Why Should I Volunteer in a Clinical Trial?
As a clinical trial participant you:
- Have the opportunity to receive a new, investigational medication to treat your condition.
- Learn about and contribute to the latest advances in treating your condition.
- May receive some medical care free of charge (ask your study coordinator for details).
- Will be closely monitored by the study nurse and physician.
How Do I Learn More?
In considering participation in a clinical trial, you should ask your doctor or the study coordinator any questions you have regarding treatment. Some of these questions may include:
- What is the study trying to find out? How long will it last?
- What kinds of test and exams will I have to take while I'm in the study? How much time do these take?
- What is involved in each test?
- How often does the study require me to go to the doctor or clinic?
- What side effects can I expect from the treatment being tested?
- How do they compare with side effects of standard treatment? How long does the study last?
- What will happen at the end of the study?