Researchers question traditional efficacy trial model
As part of their research, Professors Jorgen Vestbo and Ashley Woodcock from The University of Manchester's School of Biological Sciences conducted an effectiveness and safety trial of fluticasone furoate-vilanterol to manage COPD.
Their report, Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice, was published in the New England Journal of Medicine.
According to the researchers, instead of using a traditional randomized cohort, the new study used representative patients who were already receiving care from a general practitioner (GP). In addition to providing the patient pool, the GPs continued administering the patients’ usual care which was built into the trial – basing the study in a real clinical environment.
“In Manchester we have a strong interest in drug evaluation and respiratory medicine and we wanted to make use of a real-time combined electronic health record linking primary and secondary care for evaluating treatment in everyday practice,” Vestbo, one of the study’s lead researchers, told Outsourcing-Pharma.com.
Additionally, GSK was in the registration phase of a new combined ICS/LABA (Relvar/Breo) and the researchers said they were “aware that there is a need for showing effectiveness and not just efficacy for new drugs.”
As per the study’s results, Vestbo said it revealed “First, that a randomized trial of a non-registered medication was feasible in an everyday setting where patients were unselected and were not handled as patients are in an efficacy trial,” and the new combination drug was more efficient than the usual care selected by GPs in reducing moderate and severe exacerbations of COPD.
Ultimately, Vestbo said that traditional trials (efficacy trials) will always be needed to test what a drug can do. However, he concluded, “contrary to the present situation, we need more studies to show what a drug actually does do when used by real patients and not just in selected trial participants.”
