You’ve likely heard of clinical trials before, but what exactly is clinical research and how can it help patients?
Clinical trials are research studies performed with participants to assess specific medical, surgical, or behavioral interventions. Trials represent one aspect of clinical research; the other is observational studies where researchers simply record what they see based on a risk factor.
The purpose of clinical trials is to help medical researchers discover if a new treatment option (like a new drug or medical device) is beneficial and safe for human use, or if a new treatment is more effective and/or has less harmful side effects than a standard treatment. Trials are regularly used to learn how to diagnose a disease early, to prevent certain health problems, or to improve quality of life for someone living with a chronic disease. Behaviorally, they can also be used to study the role of a caregiver or support group.
All clinical trials in the United States require approval from the Food and Drug Administration (FDA) before they can begin. Scientists also first conduct lab tests and studies in animals to assess a potential therapy’s safety. If there are no adverse results in these animal studies, the FDA may approve its use in humans.
The Anatomy of a Clinical Trial: Exploring the Phases
Clinical trials go through four stages to test each intervention, discover the correct dosage, and identify side effects. If a medical intervention passes the first three stages, the FDA can clear it for clinical use as any side effects are continuously monitored.
A Phase I clinical trial tests an experimental treatment on a small group of people. This group may range from 20 to 80 healthy persons to assess its safety, identify any side effects, and find the appropriate drug dosage.
This stage increases the number of people in the trial (generally 100 to 300). The emphasis switches the safety analysis in Phase I, to assessing the effectiveness of the medical treatment.
A Phase II clinical trial seeks to gather preliminary data on if a drug helps people with specific medical conditions. These trials will still consider the short-term side effects of the intervention. It should also be noted that a Phase II trial can last for several years.
Once a clinical trial gets to Phase III, it is possible to gather more information regarding:
• Safety and effectiveness of the medical intervention
• Use of the drug or device in various populations and a range of dosages
• Drug’s or device’s interactions with other medical treatments
A Phase III trial has an even larger number of participants ranging from several hundred to approximately 3,000 participants. The larger sample size allows more reliable and detailed conclusions to be drawn from the clinical trial.
The FDA also assesses the results of the clinical trial at this stage. If they are positive, the medical intervention can be approved for experimental use.
In Phase IV, the drug or device is evaluated for its effectiveness and safety in larger and more diverse populations. At this stage, any small effects of the treatment become more apparent as more people would have used it over a longer period.
Helping to Advance Medicine
Clinical trials are critical in advancing how we treat diseases and conditions. They may focus on early disease detection (especially before symptoms emerge) to help people access a treatment sooner. Others may also seek to prevent disease, or help people live more functionally with chronic or life-threatening illnesses. They may also help stressed caregivers in their supportive roles. The goal is to improve the quality of life for those studied.
Insight Clinical Trials is one of the leading independent medical research institutes in Northern Ohio. We specialize in clinical research and treatment involving pain, depression, ADHD, Alzheimer’s, and other neuropsychiatric disorders. Our team of medical experts stands ready to help participants access the latest medical interventions and healthcare.
Contact us today to learn more about what our clinical trials are, and answer any questions you may have.