Phase IV is the fastest-growing area of clinical research today. A changing regulatory environment, growing concerns about the safety of new medicines, and various uses for large-scale, real-world data on marketed drugs' safety and efficacy are primary drivers of the growth seen in the Phase IV research environment today.
Post-marketing research is an important element of commercialization that enables companies to expand existing markets, enter new markets, develop and deliver messaging that directly compares their products with the competition, and secure a niche position in crowded markets.
Example: In collaboration with Hoffmann-La Roche AG (Grenzach-Wyhlen, Germany) we have investigated the effect of one of their approved drugs in prophylactic versus preemptive treatment of cytomegalovirus (CMV) infection in the context of graft rejection after renal transplantation. We analyzed urine samples obtained from patients over the course of therapy in a multicenter, national and open randomised comparative phase IV study. CMV infected patients had a polypeptide pattern indicative of CMV induced graft alteration, and proteomics allowed patients to be assigned to their treatment groups ( /- infection) with 100% sensitivity and 90% specificity. The results indicate that prophylactic therapy reduces the incidence of CMV infection and prolongs the time to first CMV infection.
An additional multicenter, international trial is under current investigation.