What are clinical trials?
Clinical research studies, also called clinical trials, are research studies in which participants are asked to take a study drug under the supervision of a physician and other research professionals. A study drug is one that is not approved by a health authority such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
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 study-related medical tests and exams before, during, and sometimes even after the study.
Who conducts clinical research studies?
Governments and sponsor companies (such as pharmaceutical or biotechnology) typically run clinical research studies. They are responsible for creating a strict study protocol (a written description of a research study) and ensuring that all people involved follow it throughout the course of 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 form” and will be discussed with you. You will be asked to review and sign the informed consent form prior to participating to show that you understand the study and its possible risks and benefits.
If you qualify, you may be enrolled in the clinical research study. Once enrolled, feel free to discuss your research care with the study doctor or study team members at any time during the course of your study participation.
It is important for you to:- Attend all scheduled visits
- Adhere to the treatment and follow-up schedules
- 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. You will also have the right to leave the study at any time for any reason.
Can I leave the study if I change my mind?
Participation in any clinical research study is completely voluntary, and participants may withdraw from a clinical research study at any time for any reason without penalty or loss of medical care or benefits to which you are entitled. If you would like to leave the study, you should discuss this with your study doctor, who will give you information about how to do this safely and make arrangements for further medical care and follow-up.
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• a screening period of approximately 35 days,
• an initial 24-week treatment period (which may be extended if certain criteria are met and if you continue to benefit from the treatment), and
• a follow-up period where you will be contacted approximately every 12 weeks to ask how you are doing.
The study drug being used in the COMMANDS Trial is called luspatercept, which is a protein that aims to help increase the production of red blood cells in bone marrow. Luspatercept will be administered as an injection every three weeks during the treatment period.