Postmarket surveillance is the process of monitoring the safety of a new treatment once it has been approved by the FDA. Because clinical trials are conducted in small numbers of patients, new issues may arise when a treatment is used by a larger population after approval. Your patient group can provide a bridge between patients, industry, and the FDA to help with postmarket surveillance.
Getting the right diagnosis can take many years, especially for rare diseases. Your patient group can work to promote programs to speed diagnosis, such as outreach to healthcare professionals or public awareness campaigns. Screening programs can be developed to identify the condition before symptoms develop. For example, a newborn screening program may be developed to identify infants who need immediate treatment.
Public and private insurance providers make decisions on the value of a newly approved therapy and determine how these new treatments will be covered. Your patient group can identify any barriers to reimbursement and interact with payers to promote coverage.
Your patient group can promote the development of clinical guidelines to help standardize care for your disease. Patients and their caregivers can provide input about symptoms, side effects of medications, and importance of therapies.