It’s important to be well-informed about your participation in a clinical trialA clinical trial is research designed to understand the safety and efficacy of a drug, biologic or device. There are 4 phases to most clinical trials from Phase 1 that seeks to answer safety concern. Use this informational sheet to help ask important questions prior to enrolling in a clinical trial for Krabbe disease.
Questions for the Principal Investigator:
- How many participants have enrolled in this clinical trial thus far?
- What is the total time commitment to participate in the clinical trial from start to end?
- What’s the mean age of the participants enrolled in this clinical trial?
- What other treatments are utilized for Krabbe disease?
- What types of long-term benefits are expected for participants?
- Does participation in this trial disqualify participants from other clinical trials and/or treatments?
- What expenses will or will not be covered for participants in this clinical trial?
- Will we need to relocate and if yes, are those costs covered?
- What follow-up visits and tests will be required for participates in this clinical trial?
- Will we receive a stipend for our participation in this clinical trial to help offset out-of-pocket costs?
- What are the risks and side effects of the treatment. How many participants experience the side effects?
- Who will have access to participant information due to our enrollment in this clinical trial?
- Will we receive copies of information collected in this clinical trial? For example, results from genetic testing, copies of MRI’s, developmental testing, clinical trial outcomes, and more.
- How do you partner with local doctor/s to ensure participants receive necessary support upon return of home?
- Are participants allowed to be removed from the clinical trial at any point in time? Download
Clinical Trials 101: Key Things to Know About Studies in Krabbe disease
Original Record Date: Sunday, March 21st, 2021
There’s a lot of information to evaluate when clinical trial becomes available. For example, who is able to enroll, what does exclusion and inclusion criteria mean, how does a clinical trial work and so much more. This 1-hour webinar is crafted to help you easily navigate a clinical trial and answer some questions about the new Krabbe disease clinicals trials offered by Forge Biologics, Passage Bio, and Polaryx.