“Real world evidence” clinical trials – paradigm shift in clinical research?
Results obtained from clinical trials usually have limited relevance to everyday clinical practice. Trying to overcome this, researchers from School of Biological Sciences at the University of Manchester conducted a trial with a brand new design – integrated comparative effectiveness trial.
Researchers investigated comparative effectiveness and safety of the once-daily inhaled fluticasone fuorate + vilanterol combination against usual maintenance therapy in patients with COPD. Interestingly, study was initiated before the approval of fluticasone furoate + vilanterol combination in the United Kingdom. Patients were enrolled into the study by their routine health care providers in 75 general practices in Salford and its surroundings. Study data were obtained via an electronic healthcare system that is normally used for information exchange between primary and secondary care. Researchers successfully recruited 2799 patients and completed the study.
Although such design has certain limitations, it is obvious that “real world” clinical trials can substantially decrease the cost and timelines for the registration of certain drug combinations. Further details, including the description of study design and main results can be found in The New England Journal of Medicine.