Clinical Trials: What Are They and Who Should Participate?

March 29, 2018 | Addiction Policy Forum

What is a clinical trial?

When doctors want to test a new approach for treating a disease, first they have to prove that it is safe for patients and then they have to prove that it is effective. They do this through clinical trials, a type of research study that involves testing the new approach on participants. Such interventions can include a new drug, a combination of existing drugs, and new medical devices, procedures or treatments. Because these trials involve people, they are highly regulated by the Food and Drug Administration (FDA).
 
In the U.S., medical researchers have to get approval for clinical trials from institutional review boards, commonly called IRBs, which include doctors, researchers and, importantly, community members who can represent the concerns of potential research subjects and the broader community. The IRB’s role is to ensure that a study is ethical and that the rights and welfare of the people participating in a clinical trial are protected. Participants--formally referred to as “human subjects”-- are told about the potential risks and benefits of the new approach through a process call informed consent.
 
Clinical trials must follow detailed protocols that outline the key questions that scientists hope to answer and the process they will use to find those answers. Questions include:
 
  • Who can participate in the study?
  • How many participants are needed?
  • What new treatment or intervention will be studied?
  • How much and how often will the treatment or intervention be delivered?
  • How long will the study run?
  • What questions will the study answer?
  • What information will be gathered from participants?
 
 
Who should participate in clinical trials?
 
While interventions must first be proven safe in animal studies, this doesn’t mean that clinical trials do not pose any risks. However, these risks are managed through rigorous oversight of trials and continuous monitoring of participants for any signs of adverse health effects.
 
People choose to participate in clinical trials for many reasons, including:
 
  • Wanting to try a new drug they would not otherwise be able to access.
  • Interest in the potential for a new approach to help with a health condition they are struggling with.
  • An altruistic desire to advance medicine or to help others, such as family members or friends affected by a specific disease.
  • Financial compensation.
 
Current Volunteer Opportunities in Addiction Research
 
Medical professionals are responding to the growing demand for treatments to help patients with substance use disorders by initiating much needed research into the science of addiction, prevention methods and new treatments.  The Addiction Policy Forum is working with partner organizations to help researchers develop cutting-edge interventions—and clinical trials are an important part of this effort. The following two studies are currently recruiting volunteers:
 
Opioid Use Disorder Research Protocol: National Institute of Health (NIH) scientists are seeking participants who are dependent on opioids despite clinically significant distress or impairment. They want to learn how opioid use affects messages being sent between cells in the brain. You or your doctor can email Minoo McFarland for more information: minoo.mcfarland@nih.gov
 
Alcohol Use Disorder Inpatient Treatment Admission: NIH scientists are seeking participants who are dependent on alcohol. They want to find out if eating a ketogenic diet, which is high in fat and low in carbohydrates, affects brain function or withdrawal symptoms in patients undergoing inpatient alcohol detoxification. You or your doctor can email Megan Carraco for more information: megan.carraco@nih.gov



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