Your responses, comments, and overall engagement will aid the FDA in incorporating the voice of the patient in PML clinical trial design.
The FDA is interested in:
1. What aspects, if any, of a clinical trial evaluating an investigational treatment for PML would encourage you (or the patient if you are a caregiver) to consider participating in the trial? If you (or the patient if you are a caregiver) have already participated in a PML clinical trial, what helped you/them make that decision?
2. What, if any, aspects or features of a clinical trial might discourage you (or the patient if you are a caregiver) from participating? Are there factors that would prohibit participation?
Post your perspective on the questions above.
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There are currently no PML medical treatments approved by the FDA. For approval to take place, treatments must first be evaluated in one or more adequately controlled clinical trials to determine if they are safe and effective for PML patients. An investigational medical treatment is a treatment that is still in the process of being studied in a clinical trial and has not yet been approved by the FDA. Clinical trials also provide important information about a medical treatment's side effects, the required dosage, and the duration of treatment necessary to experience benefit. While participating in clinical trials can be challenging, especially for patients with PML, including as many PML patients as possible in clinical trials is important because PML is a rare and complex disease.
The FDA is interested in hearing from Progressive Multifocal Leukoencephalopathy (PML) patients, caregivers, and those at risk for PML about how clinical trials can be designed to include as many PML patients as possible.
The results from this initiative will inform discussions at the FDA PML Clinical Trial Design Workshop and may be summarized for publication. Please note that while your name will not be included in the publication, the feedback you provide might be included.