Clinical Trials 101

By participating in a clinical trial, you can help researchers discover and develop new treatments for Alpha-1. 

What is a clinical trial?

A clinical trial is a research study that involves people. Clinical trials are designed to help researchers look at new ways to prevent, detect, or treat diseases or conditions, such as Alpha-1. 

Clinical trials often study treatments, such as new drugs, new surgical procedures, or new ways to use existing treatments. Clinical trials can also study other aspects of care, such as improving quality of life for people with chronic illnesses like Alpha-1. 

Participation in clinical trials related to Alpha-1 is not limited to Alphas; depending on the clinical trial, participants may be Alphas, carriers, or other people unaffected by Alpha-1.

Interested in joining an Alpha-1 clinical trial? Talk to your doctor about clinical trials that might be right for you.

What are the phases of clinical trials? 

Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions.

  • Phase I trials test if a new treatment is safe and look for the best way to give the treatment. Researchers also look for signs that the new treatment is working to treat the condition 
  • Phase II trials test if the new treatment improves the condition 
  • Phase III trials test if a new treatment is better than a standard treatment
  • Phase IV trials find more information about long-term benefits and side effects of a new treatment

Most of the time, when you take part in a clinical trial, you will only be in one phase of the study. Treatments move through the phases, but people do not. 

What is informed consent?

Informed consent is a process in which potential clinical trials participants are given information, including potential risks and benefits, of being part of a clinical trial. People participating in a clinical trial are provided with an informed consent form that includes details about the clinical trial, such as its purpose, how long it’s expected to last, tests or procedures that will be done as part of the research, and who to contact for further information. Clinical trial participants are also given any new information that might affect their decision to stay in the clinical trials. Taking part in a clinical trial is voluntary and you can leave the study at any time.

How do I know if I am eligible to enroll in a trial?

Not all clinical trials are right for all people. Each clinical trial has rules that doctors must follow to decide who may join the clinical trial. These rules are called eligibility criteria. 

Eligibility criteria include information about a person’s condition, overall health, and other characteristics. Eligibility criteria for Alpha-1 clinical trials often include a person’s age, significant health concerns other than Alpha-1, and whether a person has had lung or liver transplant. 

What role does the Alpha-1 Research Registry play in the clinical trial recruitment process?

People who have joined the Alpha-1 Research Registry, a confidential database of Alphas and carriers, are notified when an Alpha-1 clinical trial that they may be eligible for is enrolling. Join the Alpha-1 Research Registry today to participate in Alpha-1 clinical trials that may be right for you or your family.

Watch this video to learn more about clinical trial participation

See our glossary of terms related to clinical trials and medical research