What you should know about clinical research studies.
What is a clinical research study?
A clinical research study, also known as a clinical research trial, is a carefully designed study in which participants are asked to take an investigational medication under the supervision of a doctor and other research professionals.
Clinical research studies must be reviewed 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 is an investigational medication?
An investigational medication is a medicine that has not been approved by the regulatory authorities in your country.
What should I expect?
Before you participate in a 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 for the CAD Studies, you may be enrolled into either the Cardinal Study or the Cadenza Study based on your medical history. Once enrolled, feel free to discuss your research care with the study physician or research site staff 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 medication being approved by your country’s regulatory health authority, and may result in future developments of new medications.
It is important to:
- Attend all scheduled visits
- Describe your feelings and well-being accurately and honestly to the study physician
- Complete all study assessments and scheduled doses of investigational medication
- Discuss any questions regarding the study with the study physician
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. You will also have the right to leave the study at any time. Learn more about the CAD Studies.
Find a participating research site