Patients

Clinical trials (also called studies) are research studies that rely on volunteers to help discover better ways to prevent, find, treat, or cure diseases. Once a trial is approved for human subjects, there are four unique phases.

In Phase I trials, researchers test an intervention in a small group of healthy volunteers. They want to learn if the intervention is safe, the correct dosage, and if volunteers have any reactions to or side effects from the intervention. In Phase II, III, and IV trials, researchers learn more about the safety of the intervention and how well it works in larger groups of participants.

It’s really important to note that there are laws in place that protect the safety and privacy of people who choose to participate in a clinical trial.

Clinical research aims to improve patient outcomes by identifying better treatment options, optimizing existing therapies, or developing new diagnostic tools to detect diseases earlier when they are more treatable. These studies help determine the safety and efficacy of medical treatments, interventions, drugs, or devices. This involves testing whether a new treatment is effective in treating a particular condition or disease while also ensuring that it is safe for use in humans. Overall, clinical research plays a crucial role in advancing medical knowledge, improving patient care, and ultimately saving lives.

Patient safety is our top concern when conducting clinical research. To protect the rights and welfare of clinical research participants, there are two primary governing organizations that have oversight of all clinical trials.

The Food & Drug Administration (FDA) provides regulatory oversight. They have created regulations designed to protect the human subjects participating in studies.

An Institutional Review Board (IRB) provides ethical oversight. They are responsible for ensuring protocols are ethical and don’t pose unnecessary danger to participants. They also ensure the sites are competent to conduct studies.