Here are some common questions and answers about study participation.
What are clinical research studies (trials)?
Clinical research studies, or trials, help scientists and physicians explore whether an investigational medical strategy, device, or medication is safe and effective for people. Before any medication can be approved, it must go through several phases of clinical research.
What is informed consent?
Before enrolling in a clinical study, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
What does study participation involve?
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments done to monitor your health. More details about specific study participation can be provided to you by the site study staff or investigator.
Participation in clinical research studies is your choice, and you may stop at any time. Talk to your doctor for additional information on clinical research studies and to learn more about eligibility for available studies like the CONNECT1-EDO51 Study.
What are the costs of participating?
Costs associated with the study, including costs for the investigational drug, study supplies, study visits, and/or necessary tests, are covered. You will be compensated for your study visit time and will be eligible for reasonable travel expense reimbursement.
Will I benefit from participating?
You will play an active role in your own health care, will receive frequent health check-ups as part of your participation, and may help others by contributing to what we know about Duchenne. As the therapy is investigational, its potential benefits are still being studied.
If you have additional questions about participating in this clinical research study, please send an email to clinicaltrials@pepgen.com or visit clinicaltrials.gov to learn more.
