Flu iiq

Measuring the impact of influenza on individuals

The flu-iiQTM  has been serving the pharmaceutical industry since 2011 – providing critical data to inform the FDA and other national regulatory agencies on the effectiveness of new and existing products.

The importance of PROMs
The assessment of the effectiveness of treatments in clinical trials has traditionally focused on biological and clinical indicators of the presence or absence of disease or survival of effected individuals. Often the patient’s perspective is ignored when new treatments are evaluated and very little information is collected on the impact of novel interventions or regimens on the quality of life of patients.

With the advent of questionnaire-based measures (ie. PROMs)where the patient provides their own judgment of their symptoms and health status, important information on the value and impact of treatments can be gathered. The provision of such information, ie. from the patient’s perspective, has become critical for regulatory authorities such as the US Food and Drug Administration (FDA) and similar agencies in other countries.

Much early work in this field was driven by oncology where new treatments designed to reduce tumour load were also found to greatly influence life quality. Although some new treatments were found to increase the length of life, the toxic side effects of the drugs were so severe there was little net gain from the patient’s perspective. A balance had to be struck between a length of life and life quality.

Breadth and depth in outcomes research through high quality PROMs
Since these early studies, questionnaires that capture the patient perspective have risen to great prominence. Not only are side effects of new agents evaluated, but the broader impacts on subjective aspects of life quality can be evaluated through well-designed questionnaires that are used to generate a more complete picture of the therapeutic efficacy of new agents.

Some investigational drugs might not reduce influenza onset or overall duration, but the Quality of Life or ability to do usual life activities of affected patients might be greatly improved. These data can be discovered if the flu-iiQTM is administered within a clinical trial.

A questionnaire specifically designed for people with influenza is able to evaluate whether new agents, including vaccines and anti-viral drugs, have a wide variety of potential patient centred benefits. Comprehensive evaluation of the potential range of benefits of new agents requires a valid and sensitive comprehensive multidimensional PROM. The flu-iiQTM has been delivering these benefits to the pharmaceutical industry since 2011.