What are clinical trials?
A clinical trial is a research study involving human participants that aims to assess the safety and effectiveness of new medical treatments, drugs, or devices.
These trials follow a structured protocol and are conducted in distinct phases, each designed to address specific research questions. Participants may receive either the experimental treatment standard therapies, or a placebo, enabling researchers to compare outcomes and identify the most effective options. These studies are intended to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Did You Know...
Every drug, device, tool, diagnostic test, technique, and technology used in medicine today was once tested in a clinical research study?
Did You Know...
You don't need to be sick to participate in a trial. Healthy volunteers have a significant role in clinical trials because they help define "normal" ranges.
Did You Know...
As a participant in a clinical trial, you have access to experienced medical professionals at no extra cost to you.
Crucial Contributions of Clinical Trials to Medical Advancements
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Discovering new treatments
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Ensuring safety and efficacy
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Personalized medicine
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Observing long-term effects
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Paving the path for future research
How is the Safety and/or Efficacy of a Treatment Determined?
In a clinical trial, participants receive specific interventions according to the protocol created by the investigators. The interventions may be medical products, such as a drug or medical device; procedures; or changes to participants' behavior, such as diet.
The investigators try to determine the efficacy and safety of the intervention by measuring certain outcomes in the participants. Measured outcomes will vary between studies and will be outlined in the study protocol.
The 4 Phases of a clinical trial
Before any medication is available at your pharmacy or prescribed by your doctor, it must go through a series of carefully designed development phases. Each step plays a vital role in making sure the treatment is safe, effective, and ready for real-world use. The four clinical trial phases are as follows:
Phase One
New treatments or therapies are tested on a small group (less than 100) to check safety and identify side effects.
Phase Two
The same treatment or therapy is given to more people (hundreds) to further assess safety and effectiveness.
Phase Three
The treatment or therapy is given to much larger groups of people (typically more than 1,000) to confirm that it works. Researchers will continue to monitor side effects during this phase.
Phase Four
Also called "Post-Marketing Studies," these trials are conducted to obtain more information about the risks, benefits, and best use of a drug or therapy after the U.S. Food and Drug Administration (FDA) has approved it.