Collaboration between MSD and Deakin University’s professor of public health, Richard Osborne, has resulted in the development of a new way to understand the intensity and impact of the flu that will enable scientists to better assess if new treatments work.
“The development and testing of vaccines and drugs designed to reduce the severity and impact of patients’ flu symptoms requires people to report how they are feeling and for improvements in their health to be tracked during the course of their illness,” Deakin’s Professor Richard Osborne explained.
“It is important that the benefits of any new treatments and vaccines, as reported by the patient, are captured in a way that meets regulatory guidelines. Shortcomings in existing tools to assess how patients are tracking in clinical trials can cause delays in getting new treatments to the market.”
MSD epidemiologist Swati Gupta said: “Through rigorous questionnaire development and validation methods involving extensive consultation with flu patients and physicians who treat patients with flu has resulted in our development of a new questionnaire (FluiiQ) which will more accurately measure the intensity and impact of the influenza infection.”
The FluiiQ is the first in this field to attempt to fulfill the strict requirements set by major regulatory bodies such as the US Food and Drug Administration.
“Companies are making large investments over many years to find a vaccine or treatment for the flu. If they cannot appropriately measure the effectiveness of their potential new agents in clinical trials, then important drugs or vaccines may not move forward in development,” Professor Osborne said.
“With more precise measures, smaller patient sample sizes are needed in clinical trials to assess effectiveness which in turn allows for earlier and clearer decisions on new vaccines and treatments.
“Therefore, we believe the new questionnaire will help scientists to develop new agents more quickly and thus contribute to reducing the number of people who succumb to the illness each year.”
The development of the questionnaire will be discussed in Value in Health, the official journal of the International Society for Pharmacoeconomics and Outcomes Research.