Update Clinical Care Guidelines
Overview
If clinical care guidelines have been previously developed and published for your disease, you will want to ensure an updated version is published when a therapy receives U.S. Food and Drug Administration (FDA) marketing approval. You can work with your medical advisors, specialists involved in the clinical trials, and the specialists involved in the previous version of the guidelines to make sure the updates are clear and continue to provide a treatment decision framework for patients and their doctors. Addition of a new therapy will require the guidelines go through an approval process similar to the original development.
If clinical care guidelines have not previously been developed for your disease, the approval of a new therapy can be a great time for your patient group to promote and encourage the development of clinical guidelines. Patients and their caregivers can provide input about symptoms, side effects of different treatments, and the importance of therapies.