Frequently asked questions
What is a clinical trial?
What is the OPTIMA Clinical trial?
The OPTIMA Clinical Trial is testing an investigational drug as a potential treatment in people with FOP. The drug being tested is called “investigational” because it hasn’t been approved for use outside of this clinical trial. For more information regarding the trial, visit the About OPTIMA section.
Am I eligible to take part in the OPTIMA Clinical Trial?
To see if you are eligible, take our questionnaire in the Am I eligible? section.
How many people will be taking part?
What are my responsibilities if I take part?
What are the possible disadvantages to participating?
Participating in any clinical trial involves possible risks. The known and unknown risks of participating in this trial will be explained to you during the informed consent process, which takes place before you decide to participate. These risks include, but are not limited to, unwanted side effects of the investigational drug and/or that the investigational drug may not provide you with any benefit.
Clinical researchers must follow regulatory guidelines and requirements to help protect the rights, safety, and well-being of clinical trial participants. One example of these guidelines is Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing and conducting clinical trials.
There are in addition several entities that provide oversight of clinical trials. These include health authorities or regulators, institutional review boards and independent ethics committees, and data safety and monitoring boards.