FAQs

Before you join a clinical trial, it is recommended you read about the condition and treatment. You can discuss it with your usual healthcare provider or reach out directly to the clinical study team. You can also bring whatever remaining questions you have to the study team when you meet them for your screening visit. Important considerations include potential benefits and risks, what you will have to do during the trial, and for how long.

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

- The principal investigator - or PI - leads the trial at the site and directs the team of doctors, nurse, and other healthcare workers.

-The study coordinator manages day-to-day activities. The study coordinator is commonly 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) periodically reviews data to ensure participant safety and sometimes efficacy.

Participants are always welcome to visit their usual healthcare providers during a trial, and sometimes it is important for them 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, however the investigational intervention from the trial may not be available after it ends. 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.