Clinical Trial Information
Why would I want to be in a research study?
Participants in research studies are not “guinea pigs.” These medications or devices have been tested for effectiveness and safety before they are ever used on human subjects.
Often, being in a research study provides very expensive study related lab tests, physical exams, electrocardiograms, dietary counseling, etc., free of charge. People who participate in these studies are taking an active role in their own health care.
Also, by participating in a research study you may be helping others who have the same condition, as well as future generations.
What are the side effects?
The possible side effects are listed for each study in the informed consent. Most side effects listed are those common with many approved, marketed medications. After reading the informed consent, please discuss any questions you may have with the study coordinator or physician.
What should I tell my doctors?
Please discuss any research study with your doctor.
We work in conjunction with your doctor or primary care provider. Your participation in a research study at Diablo Clinical Research is in addition to the care of your doctor. Only with your prior authorization, will we share with your doctor information or results about you and your participation.
What is a placebo? What does double blind mean?
A placebo is a tablet or capsule with no active ingredients made to look like the medication being tested. Double-blind means that you and the doctor conducting the research study do not know who is receiving the study drug and who is receiving placebo. This is done so that the doctor cannot influence your reaction to the study substance and to determine the safety and effectiveness of the study drug.
What are the different phases of clinical trial research?
Phase I – evaluates the safety of the medication in a small number of healthy people, determines the appropriate dosage, and identifies side effects.
Phase II – focuses on whether the treatment works (efficacy). It involves a few hundred patients who have the relevant medical condition. Usually one group receives the experimental treatment, and another receives a placebo (in-active medication). In randomized studies, participants are assigned to each group by chance.
Phase III – emphasizes definitive statistical results. It involves giving the medication to several hundred to thousands of patients, and the response is compared with a commonly used treatment. If there is no effective existing treatment, the effects of the new treatment are compared with those of a placebo.
Phase IV – occurs after the medication has been approved by the Food and Drug Administration (FDA) and is available to the public. This post-marketing phase provides information about long-term effectiveness and side effects.
What is a clinical research study? How am I protected?
A clinical research study, or clinical trial, is a scientific study that tests potential new or investigational medical treatments, drugs, or devices. Research studies also test new uses or comparisons of known medications. Pharmaceutical companies sponsor most studies, and all must be approved by the Food & Drug Administration, (FDA). Qualified doctors, nurses, and medical researchers conduct clinical studies.
During a clinical study, you are protected by the code of regulations of the FDA, good clinical practices, the informed consent (which outlines the goals, benefits, and risks of the study), and the institutional review board, (IRB). The IRB is made up of doctors, pharmacists, clergy and law people.
Will the drug be available after the study has ended?
FDA approval of a drug is often a long process, but if the results of a study show the drug to be effective, a study drug may become available, or FDA-approved soon after a study has ended. Sometimes, open-label (everyone in the study is on the study drug) extensions follow a research study.
What are the potential risks of participating in a clinical research study?
There are generally known and unknown risks associated with clinical studies, such as:
– The treatment may not be effective for the participant.
– The protocol may require more of the participant’s time and attention than a standard treatment (participants may need to visit the study site on a regular basis, be subjected to additional tests, get more treatments than are normally necessary).
– There may be unpleasant and/or serious side effects resulting from the treatment
What are the potential benefits of participating in a clinical research study?
Clinical study participants:
Have access to potentially new treatments and help others by contributing to medical research.
Have access to expert medical care (investigators are often specialists in the disease area being studied)
Receive all tests (labs, mammograms, X-rays), physical exams, ECGs, and specialty consults (dietician, ophthalmologist, etc) free of charge.
Do not need insurance to participate and are paid for their time and travel.
Diablo Clinical Research
Where is Diablo Clinical Research? What are the telephone, fax, and email?
What is a visit like at Diablo Clinical Research?
We try to make each visit a comfortable and enjoyable one. We understand the medical condition you have, and our doctors and staff work with patients like you every day. Our staff is well trained and they are experts at what they do. We are not in a hurry and have the time to listen to your concerns and needs. We invite questions and enjoy helping you understand your condition and our clinical studies.
Who are the doctors at Diablo Clinical Research?
What are the typical services provided by Diablo Clinical Research at no charge?
Qualified study participants may receive:
- Physical examinations
- Laboratory tests
- Nutritional counseling (varies per study)
- Specialized tests (e.g. bone density, mammograms, x-rays)
- Electrocardiograms (ECG)
- Vital signs: Blood pressure, Pulse, Weight, Height
- Physician evaluation
- Study medication
- Compensation or stipend, once enrolled into study
Participation in a Clinical Research Study
How do I get into a research study?
Call Diablo Clinical Research at (925) 930-7267 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.