The new “primary partner,” non-exclusive deal means that Quintiles will recommend Invivodata’s software and support services to sponsors as its preferred method for patient feedback during clinical trials.
The contract research organisation (CRO) said formalisation of its partnership with Invivodata, which has seen the firms collaborate on 20 studies to date, is the logical response to demand for electronic patient reported outcomes (ePRO).
Paula Stafford, VP of Quintiles clinical services unit, explained that: “Regulators, especially the [US] FDA, have increased the pressure on drug developers to focus on the patient’s perspective regarding drug effects.
“While the patient perspective can be obtained in various ways, real-time PRO data are common measures of drug efficacy, and ePRO is an accurate and reliable way to capture these data.”
Invivodata’s Tom Henson told the Pittsburgh Business Times that the deal “will have a double digit effect on our business,” but did not provide a specific forecast.
ePRO
Patient reporting has long been recognised as an important aspect of the trial process because it can provide data on, for example, a candidate drug’s impact on day-to-day quality of life, which would otherwise be very difficult to measure.
Traditionally such data was collected in diaries, which while generally effective, have the obvious drawbacks, such as the requirement that the patient fill them in during the trial and that the results are interpreted accurately.
However, the emergence of the internet in the mid-90s and latterly of mobile devices, revolutionised ePRO collection by providing patients with an easy, structured means of submitting results in a way that could be rapidly collated and analysed.
These advantages are increasingly being recognised by drugmakers and regulators alike, which has in turn driven the mergence of specialist service providers within the CRO sector, with Invivodata being one of several examples.