About Clinical Trials

New medicines go through an average of 12 years of rigorous testing before they are deemed safe and effective for people to use. The tests take place in clinical research studies, which are essential for improving health and medical care.

beakers used in clinical research

About Clinical Trials

New medicines go through an average of 12 years of rigorous testing before they are deemed safe and effective for people to use. The tests take place in clinical research studies, which are essential for improving health and medical care.

What is a clinical trial?

A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation conducted by doctors and researchers to determine if an investigational medicine, device, or procedure is safe or effective.

Trials are conducted in four phases:

phase 1

Phase I trials examine the safety of an investigational medicine in healthy people

phase 2

Phase 2 trials involve assessment of safety and additional efficacy and establishing the best dosing regimen while testing safety in patients.

phase 3

Phase 3 trials confirm the efficacy and safety of an investigational medicine in patients.

phase 4

Phase 4 trials are conducted after an investigational medicine has been approved to gather additional efficacy and safety information.

Why is clinical research important?

Clinical research studies help doctors and scientists determine if investigational medicines are safe for people to take and
effective in treating a condition, disease, or disorder. In rare diseases such as wAIHA, where the population is limited and
not as much is known in comparison to other more common diseases, clinical research may be even more impactful toward
improving researchers’ understanding of the disease.

Why are participants needed for clinical research studies?

Clinical research studies often require many volunteers to participate in a single study; sometimes thousands of participants are needed to obtain reliable information. This can be especially challenging with rare diseases like wAIHA because it can be difficult to find enough patients to enroll.

Clinical Trial Educational Videos

Is a clinical research study right for you?

Clinical research study participation offers an opportunity to be part of something bigger - research that may advance understanding of a disease or help get a new treatment approved. However, participation may also involve risks. Always make sure to discuss any potential benefits and risks with your study doctor.

Benefits

  • Getting actively involved in your own healthcare
  • Regularly scheduled medical attention from a team of healthcare professionals
  • Helping others by participating in research that may result in advancing the understanding and treatment of the disease

Risks

  • The investigational treatment may not work
  • The investigational treatment may cause side effects
  • Potential to be excluded from other clinical trials