The prevalence of autoimmune diseases is rising. This comprise more than 80 chronic illnesses that arise when defects in the immune system lead the body to attack its own cells, tissues, and organs. Such diseases include rheumatoid arthritis, lupus, multiple sclerosis, and Type 1 diabetes.
Diagnosing autoimmune diseases can be challenging, which can make enrolling patients in clinical trials difficult. With a fully integrated technology platform like Clinipace’s TEMPO™, viewing and monitoring the number of patients enrolled at every investigator site can be done easily. Viewing data across all sites at every level allows for quick identification of trends. If enrollment is below expectations, study teams can adopt strategies to increase interest.
In addition, symptoms are often not present until an advanced stage of disease, making endpoint selection important in designing clinical trials. The use of TEMPO for functions like endpoint adjudication and remote site monitoring reduces cost, improves accuracy, and enables faster study close-out. Real-time data access also enables adaptive study designs that require fewer patients and increase likelihood of successful outcomes, and provides early identification of safety signals.
An understanding of Immunology is key to developing better ways of diagnosing the disease (which is particularly difficult to identify in the early stages), and producing therapeutic agents that permanently stop the ongoing immune response. Clinical immunologists, therefore, strive to diagnose the condition early, in order to treat patients with powerful drugs and reduce or prevent further damage.
Studies in this area can also include cancer immunotherapeutics, which require a development team that understands the space of immunotherapeutics as well as regulatory hurdles. With vast experience working with competent regulatory authorities around the world, we can represent you in meetings with these agencies, and can also act as your legal agent.