Clinical trials are research studies that use human volunteers to determine whether a medical strategy, treatment, or device is safe for people to use. Clinical trials aim to increase medical knowledge about disease treatment, diagnosis, and prevention through research. Clinical trials on humans are the final stage of the research process.
Although a doctor is usually at the forefront of each clinical study, a clinical trial’s research team may include nurses, scientists, data experts, social workers, and other healthcare professionals. Clinical trials are commonly conducted at hospitals, medical centers, and universities. Some clinical trials last days, while others continue for years.
WATCH: Are Clinical Trials Safe?
How do clinical trials work?
Clinical trials consist of four phases:
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Phase I
In Phase I, researchers test a drug or treatment on a small group of 20-80 people for the first time. During this phase, the safety of a drug is studied, and any potential side effects are identified.
Phase I may take several months to complete. Approximately 70% of drugs studied during Phase I move on to Phase II.
Phase II
In Phase II, a larger group of 100-300 people receive a drug or treatment to determine its effectiveness and safety further.
Phase II may last several months to two years. Approximately 33% of drugs studied during Phase II move on to Phase III.
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Phase III
In Phase III, a drug or treatment is given to large groups of 1,000-3,000 people to confirm its effectiveness, monitor side effects, and compare it with similar treatments. Information that allows the new drug or treatment to be used safely is
collected during this phase. Phase III testing may last 1 to 4 years, and approximately 25-30% of drugs tested during this phase move on to Phase IV.
Phase IV
In Phase IV, after a drug is approved by the FDA and made available to the public, researchers track a drug’s safety amongst volunteers in the general population while seeking more information about optimal benefits and use.
READ: Why Blacks Are Underrepresented In Clinical Trials
What you should consider
The clinical trial’s protocols define who is eligible to participate. Individuals may be included or excluded from a clinical trial depending on their age, gender, health, or medical conditions.
If you’d like to participate in a clinical trial, you should know the risks and potential benefits. When weighing the risks of participating in clinical research, you should think about the possible harms that could result from taking part in the study.
Most clinical trials pose only the risk of minor discomfort. Still, the specific risks associated with a clinical research protocol will be described in detail in an informed consent document which participants will consider and sign before participating in research.
A research team member will explain the study and answer any questions about the study you might have.
A well-executed clinical trial will allow you to access new research treatments before they are widely available, help others by contributing to research about new procedures, and receive professional medical attention from a research team of doctors and health professionals.
For more information on clinical trials, discover our Black Clinical Resource Center.
