What is a clinical research study?
Clinical research studies explore if new drugs and medicines are safe and effective for certain diseases. They have 4 phases:
Phase 1
To learn about a new drug and if it is safe.
Phase 2
To gather information about a new drug’s effectiveness for helping certain diseases.
Phase 3
To confirm if a drug or medicine helps certain health conditions.
Phase 4
To gather more research about the drug after it is approved for treatment.
The Spark-PA study is a Phase 2 study.
People participate in clinical research studies for different reasons. Some may participate because they want to learn more about their disease. Others volunteer to participate because they want to help researchers learn more about a disease to potentially help them and others in the future.
Clinical research studies follow a specific set of standards and are closely regulated to help keep all participants safe.
The U.S Food and Drug Administration (FDA) and an independent ethics review board has approved this study. These groups must approve any research study before it can be conducted. If you choose to participate in the Spark-PA study, the study doctor will discuss all known risks and benefits to participating before you join.
You can ask questions of the study team at any time before, during, and after the study. Before agreeing to participate, make sure that you understand the responsibilities of study participants. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study team at any time.
Study participation is completely voluntary. You do not need to take part in the study, and you can end your participation at any time, for any reason. If you think you would like to stop participating in the study, talk to the study doctor. If you decide you should leave the study early, the study doctor may ask that you return to the study clinic for a final visit to ensure your health and safety, but there will be no negative impact on future care you receive.
You can visit any doctor to meet your health needs during the study. You should let your study doctor know that you will be seeing another doctor and if any other medication has been prescribed. You should also let your other doctors know that you are participating in a clinical research study.
