Before joining a clinical trial, it's important to:

• Learn about the condition and treatment: Understand what the trial is studying and testing.
• Consult your healthcare provider: Discuss the trial with your doctor to see if it's suitable for you.
• Contact the study team: Reach out to the trial organizers for more information and to ask questions.
• Consider key factors: Think about the potential benefits and risks, what participation involves, and the trial's duration.

These steps will help you make an informed decision about participating in the clinical trial.

There are a wide variety of professionals involved with any study, all of which are vital to help ensure safety:

• The principal investigator (PI) leads the trial at the site and directs the team of doctors, nurses, and other healthcare workers.
• The study coordinator manages day-to-day activities. The study coordinator is usually the main contact for participants. 
• An Independent Ethics Committee (IEC) or an Institutional Review Board (IRB) monitors the study to ensure participant protection rules are closely followed. 
• An independent Data and Safety Monitoring Board (DSMB) is a group of experts who regularly check the information collected during a study to ensure that it is safe for the participants. They may also look at how well the treatment is working. Based on their findings, they advise the people in charge of the study on whether to continue, change, or stop the study.

Participants are always welcome to visit their usual healthcare providers during a trial, and sometimes it is important for their providers to collaborate with the study team.

For patient safety, participants should attend each scheduled trial visit. If you have a conflict, please contact your study team in advance to adjust your visit date.

Participants will continue ongoing care through their primary healthcare provider. The investigational intervention may only be available while you are in the trial, as each study is different.

After your participation ends, the study may continue for months or years. Usually, Otsuka clinical trial results are shared with you when the trial ends but sometimes they may never be shared. Once final results from all participants are compiled and analyzed, they are often published publicly. Check with your study team to learn more.