What is a clinical research study?
A clinical research study, also known as a clinical trial, is a carefully designed study in which participants are asked to take an investigational study drug (or placebo) under the supervision of a doctor and other research professionals.
Clinical research studies must be approved by an institutional review board (IRB) or ethics committee (EC). An IRB or EC is a group that is responsible for helping to protect the rights and welfare of study participants. In addition, every study participant is monitored with medical tests and study-related exams before, during, and sometimes even after the study.
What should I expect?
Before you participate in a clinical research study, a detailed description of the study, as well as possible risks and benefits, will be provided in writing in an “informed consent document” and discussed with you. You will be asked to review and sign the informed consent document prior to participating. Your medical history will be reviewed, and you will be given a study-related physical exam and laboratory tests.
If you qualify, you will be enrolled in the clinical research study. Once enrolled, feel free to discuss your research care with the study doctor or research site staff members at any time during the course of the study. Information collected during a clinical research study may or may not ultimately lead to the investigational drug’s being approved by the FDA or other regulatory health authorities, and may support the future development of new drugs.
It is important for you to:
- Attend all scheduled visits
- Describe your physical state, feelings, and well-being accurately and honestly to the study doctor
- Discuss any questions regarding the study with the study doctor
As a study participant, you will have the right to contact the study’s IRB or EC representative regarding your rights as a research participant at any time. You will also have the right to leave the study at any time.