Although alcoholism and addiction have historically been viewed as social ills, modern medical research has proven that substance abuse is a disease that can be treated. Traditional treatment typically involves psychological counseling, but understanding the physiology of alcoholism and addiction is just as important. That’s why the Pearson Center combines the latest biomedical research with new clinical treatments to develop innovative ways to aid the addiction recovery process. To learn more, take a look at some of the most frequently asked questions about clinical research below.
What is clinical research?
Clinical research tests new scientific ideas to discover better ways to treat, prevent, diagnose and understand specific diseases. What separates clinical research from lab-based research is the involvement of human volunteers. Clinical trials follow strict ethical and legal codes and regulations to protect the safety and rights of research volunteers, who are instrumental in ushering new medications and treatments through the FDA approval process.
What are the potential benefits of participating in a clinical trial?
Aside from the opportunity to help researchers treat diseases, research volunteers are able to take an active role in their own healthcare and gain access to new drugs and treatments, often years before they’re available to the general public.
What are risks of participating in a clinical trial?
Clinical trials often require a significant time commitment, and there is no guarantee the treatment will work. Additionally, because the drugs and treatments being studied are new, possible side effects are not widely known. However, all known risks are fully explained to each volunteer in advance, and participants are protected by strict federal regulations.
What are “blind” or “masked” studies?
One of the ways researchers can determine the effectiveness of a drug or treatment is to separate participants into two groups: one that is given the new drug or treatment, and another—the control group—that receives standard treatment, no treatment, or a placebo. In “blind” or “masked” studies, volunteers are unaware of which group they are in, and in a “double-blind” or “double-masked” study, the researchers are also unaware of which group is which. This ensures expectations from the participants and researchers cannot influence the observations or results.
How is eligibility determined to join a clinical trial?
All clinical trials have guidelines about who can participate, based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Above all, researchers use eligibility criteria to be sure the study is a good fit for potential participants, in order to keep them safe and to get the most useful information from the trial.
What are clinical trial “phases”?
Clinical trials of experimental drugs and treatments proceed through four phases:
- Phase I: Researchers test a new drug or treatment to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II: The drug or treatment is given to a large group of people to see if the drug or treatment is effective and to further evaluate its safety.
- Phase III: The drug or treatment is given to a larger group of people to confirm its effectiveness, monitor side effects, compare it to other commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase IV: Researchers continue testing the drug or treatment after it has been approved by the FDA, in order to collect information about its effect in various populations and gather data on any side effects associated with long-term use.
What is informed consent in clinical research trials?
Before volunteers agree to a clinical trial, the research team will go over key facts with them in a process called informed consent. Details will include:
- The purpose of the research
- How long the clinical trial will last
- What will be required of participants
- Which parts of the study are experimental
- Possible risks
- Who will have access to study records
- Who to contact with questions about the study and participant rights
Researchers will answer any questions during the informed consent process, which continues throughout the clinical trial so that new information is constantly available to participants.
Can participants quit during a clinical research trial?
Yes, volunteers can leave a clinical trial at any time and for any reason.
Research studies at the Pearson Center for Alcoholism & Addiction Research in San Diego
The Pearson Center for Alcoholism and Addiction Research in La Jolla offers both treatment-based and non-treatment research studies focusing on alcohol addiction. For more information, please call us at 858-784-7867.