Читать книгу The SAGE Encyclopedia of Stem Cell Research - Группа авторов - Страница 428

Phase IV studies, also called post-marketing surveillance trials, are conducted after a drug is introduced into the market for consumer sale. The objectives are to compare a drug with other drugs already in the market; to monitor long-term effectiveness and impact on a patient’s quality of life; and to determine the cost effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in drugs being taken off the market or use restrictions could be placed on the product, depending on the results. Important Phase IV studies in the United States include the following.

 Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial. This trial will evaluate the effects of Rebif® on remyelination/demyelination; lesion and brain volume; CNS iron deposition, and immune status in subjects with RRMS using MRI techniques.

 A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis. This study will use ocular coherence tomography (OCT) to compare the melanocortin-mediated anti-inflammatory effects of adrenocorticotropic hormone (ACTH) and intravenous methylprednisone therapy on axonal injury following ON by limiting inflammatory optic nerve injury.

 An fMRI (Functional Magnetic Resonance Imaging) Research Study to Learn More About MS and Individuals Potentially Experiencing Memory Difficulties. This study will determine if medication designed to improve memory, for example, donepezil will help patients with MS who are experiencing memory problems using fMRI to track brain activity.

 Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis. Evaluated the efficacy, safety, and tolerability of combination therapy with intramuscular interferon beta-1a and oral doxycycline in patients with RRMS.

 Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns.