Clinical trials are research studies in which people volunteer to test new drugs or devices. These trials are conducted by scientists to determine if new treatments work and are safe for people. Clinical trials follow strict scientific standards that protect patients and work to produce reliable results.
Clinical trials occur at the end of the research process. There are three key phases to clinic trials which include:
Phase 1: This phase is focused on a small group of healthy individuals (20 to 100) to determine the safety and effects of a specific medication.
Phase 2: This phase is focused on a larger group (100 to 500) of individuals with the specific disease or condition the medicine is designed to treat. This phase will help determine the effectiveness, side effects and optimal dosing of the medication.
Phase 3: This phase is focused on a much larger group (1,000 to 5,000) of individuals with hopes of generating statistically significant outcomes.
People choose to participate in clinical trials for a variety of reasons. Participation in clinical trials will often offer a patient access to the latest and most innovative treatment options. Healthy volunteers often select to participate in clinical trials because it helps others and advances science.
Clinical trials offer hope to many people and provide scientists the opportunity to discover better treatments and improve patient care. In fact, without clinical trials, new drugs and devices cannot become broadly available to patients.
Resources for More Information
If you are interested in learning more about clinical trials, you should talk to your healthcare team for guidance. In additional to your healthcare team, these organizations offer in-depth and valuable information about clinical trial participation:
- Center for Information & Study on Clinical Research Participation (CISCRP)
- National Institutes of Health (NIH)
Clinical Trials That May Interest You
Important Notice: This content is presented for information purposes only. Mended Hearts does not endorse any clinical trials; decisions about participation should be carefully considered with patient, healthcare team and caregiver input.
SPIRE Program (Pfizer)
The SPIRE program is a series of clinical studies that is investigating a study drug in people who have high cholesterol. This study drug is being evaluated to understand its effects on bad cholesterol (LDL-C) and cardiovascular events such as heart attack and stroke.