About clinical studies1
People volunteer for clinical studies to help researchers learn about new and existing treatments. Carefully conducted clinical studies—led by medical doctors called principal investigators—are the optimal way to find new treatments.
Clinical studies are conducted at approved study sites such as hospitals, universities, doctors’ offices, and community clinics.
The following terms are commonplace in clinical studies. You may want to familiarize yourself with them to properly understand how they work.
Each clinical study has a plan, called a protocol, which must be conducted according to strict scientific and ethical principles.
Details include participation criteria (also called inclusion criteria), test schedules, procedures, medications, and study length.
Sometimes, a drug undergoing investigation is compared against a placebo, also called a sugar pill.
The placebo looks like the study drug, but contains no active ingredients. Using a placebo helps increase the possibility that any effects seen in the study are due only to the study drug itself.
Inclusion and exclusion criteria
Inclusion criteria are the factors that allow someone to participate in the study. Exclusion criteria are factors that prohibit someone from participating in a study.
These criteria are part of the study protocol, and help to set parameters for study outcomes.
FDA approval process1
The development of potential treatments is divided into steps called “phases.” Generally, the study treatment must pass through each phase successfully before it can continue on to the next.
- Receiving regular, close monitoring and care from an experienced research team
- Helping others by contributing to medical research
- Gaining access to investigational treatments
- Playing an active role in your own health care
Risks and disadvantages1
- Unpleasant, serious, or even life-threatening adverse effects of the treatments being tested
- Time commitments for study participation
- The treatment being studied may not work
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