You may choose to participate in a clinical study for a variety of reasons. Before you do, you should carefully consider whether the trial is right for you. Trial investigators also need to determine whether you’re eligible to participate.
Who can participate?
Investigators use participation guidelines to show which characteristics they are seeking in subjects. The factors that allow someone to participate are “inclusion criteria” and those that disqualify someone are called “exclusion criteria.” These may include:
• Age
• Gender
• Type and stage of a disease
• Previous treatment history
• Other medical conditions
Guidelines for participation ensure that the results of the trial will reflect the treatment being studied, rather than outside factors. This helps researchers achieve accurate and meaningful results.
Enrolling in a Study
Participating in a clinical trial may yield significant health benefits. Many of our studies are simply “investigational” use of an already FDA approved medications, treatments or device. Anytime there is even a slight change to a medication it requires a whole new clinical trial and during the trial all drugs are considered “investigational” for study purposes. We do study some new drugs as well and if you are considering joining a study, you should educate yourself about the process, risks, and benefits. Much of this information is in the informed consent document that you will need to sign before participating.
In addition, our Clinical Research Coordinators are Certified Professionals by ACRP and SoCRA. They can discuss the study with you and answer any questions you may have about the study.
Here are some questions that might be helpful for you to ask:
• How long will the trial last?
• What kinds of treatments, tests, or procedures will I have during the study?
How do they compare with what I would receive outside the study?
• What is the main purpose of the trial? In what phase is the trial?
• Why do researchers believe the treatment being tested may be effective?
Has it been tested before?
• What are the possible short- and long-term risks, side effects, and benefits to me? How do they compare with standard treatment?
• Will I be able to see my own doctor? Who will be in charge of my care?
• Who is sponsoring the trial?
• Will I have to pay for any part of the trial?
• What is my health insurance likely to cover?
• What happens if I become sick while participating in a trial?
• Can I choose to remain on this treatment after the trial is over?
• How are the study data and patient safety being monitored?
• When and where will study results and information go?
Does it cost anything to participate?
All clinical tests, examinations, rescue medications and assigned study drug are provided to qualified participants at no cost. Financial compensation may also be provided to those who qualify to cover time and travel expenses related to the clinical research study. The amount of available compensation will be discussed with you by the clinical research study staff.
Are there benefits to participating?
You may not directly benefit from participating in this research study as your symptoms may improve, get worse or stay the same. However, your response to this study drug may give researchers more information about treatment. And any new information that is received from this research study may help other patients in the future.
Does it cost anything to participate?
All clinical tests, examinations, rescue medications and assigned study drug are provided to qualified participants at no cost. Financial compensation may also be provided to those who qualify to cover time and travel expenses related to the clinical research study. The amount of available compensation will be discussed with you by the clinical research study staff.
Are there benefits to participating?
You may not directly benefit from participating in this research study as your symptoms may improve, get worse or stay the same. However, your response to study drug may give researchers more information about treatments. And any new information that is received from a research study may help other patients in the future.
What should I do now?
If participating in a clinical research study is something you think you might be interested in, please contact one of our Site Study Specialists at our office 916-484-0500 or to help you find the right study for you. You can also talk with your family and/or with your doctor if you choose to do so.
How do I get into a research study?
Call Northern California Research at 916-484-0500 and a recruitment specialist will review your medical history with you, or submit right from here:
Do I get paid to be a research volunteer? What is a stipend?
Once you are enrolled in a research study, a stipend is provided for your participation. A stipend is a fixed amount of money paid periodically for services or to defray expenses.
What if you don’t have any research programs for me?
You may want to call the clinic and complete a medical history questionnaire with a recruiter, or submit your medical information online with our volunteer form. New studies start often and we will contact people in our database that may qualify.
Does my participation in a study affect my medical insurance? Will my insurance be billed, or my participation in a study be reported to my insurance company?
The study-related medical care and supplies you receive during a study are paid for by the sponsor of the clinical study, therefore your medical insurance will not be involved.
Your participation is confidential and insurance companies are not informed of your participation, unless there is an insurance claim directly related to your participation in a study. In this case, information about your health care may need to be released for the purpose of resolving your insurance claim.
How long are the visits?
Study visits can last from a few minutes to several hours. However, most visits take about an hour and can be scheduled to meet your needs, (very early in the morning through late in the afternoon).
Can I continue my medication?
That depends. Usually you can continue medications for conditions not related to the study.
What if I change my mind and want to quit the study?
You can discontinue at anytime. Participation in clinical research is voluntary.
Can I do more than one study?
Yes. There is no limit to the number of studies you can participate in, but you can only be enrolled in one study at a time. Typically there must be at least a 30-day period between studies.