In June 2011, Pfizer began what it claimed was the first virtual trial using mobile phones and web technology to record data from patients remotely. Last week Pfizer’s Vice President, Development Operations, Global Head Clinical Innovation and Informatics, Worldwide Research & Development, Barbara Tardiff spoke of the continuous importance in keeping up with innovation in this field.
“There is new evidence, new data with more sophisticated analytics, advances in science and also new technologies which are changing how studies are executed,” she told the room at Partnerships in Clinical Trials (PCT) in Vienna, Austria.
With a virtual study, she continued, the “patient takes a much more active role in the whole setup,” and there is an opportunity to incorporate how the use of mobile technology can be incorporated, “staying connected to the patient through the course of the study and beyond.”
Citing that 20% of smartphone users already track their personal data (weight, diet etc) with fitness and regime apps, she said “if every patient who potentially qualified for a study was presented with the option to use their smartphone, they would become participants and different than being a subject.”
“[Patients] are engaged and committed… sharing info in their social network, and we need to think about how to take advantage of this,” she added. “The patient can be in a very unique role of being an aggregator of diverse clinical data,” shifting the driver from the investigators to the patients themselves.
Outsourcing-Pharma.com spoke with the firm’s Director of Business Operations, Cameron Robertson, in Vienna last week to discuss the technology, the REMOTE trial and future applications.
In the Pfizer trial, “the patient’s entire interaction through the trial was via the web and using a mobile app on a phone that Exco InTouch provided,” he continued, and from the enrolment itself to the capturing of data “there was no interaction with a clinician for the patients.”
However, Robertson told us “the uptake of patients wasn’t as high as had been hoped, probably because of the patient population, which was a disappointment as this was one of the key challenges that the design was meant to overcome.
“As a solution it worked fantastically but we didn’t have the sample size that we needed to conclude the study in that patient population.”
Clinical to Commercial
When asked about Tardiff’s optimism for the future use of this technology, Robertson admitted that in the past certain challenges and conservatism in the industry in adopting to a new approach may have held the technology back, but “that’s now changing as the use of that technology not only provides an ideal solution for patient interaction in a clinical trial setting but you can also take that beyond into the commercial setting.”
With smartphones now a common occurrence, there is “an enormous capability for capturing data and providing ways for patients to interact through their mobile device,” he said.
“Through [such technology] we can channel reminders - very basic things about clinic visits, when to take their doses, perhaps complete a diary assessement - and can also provide info that’s useful to them and allows them to help manage their condition.”
AstraZeneca & CRO Interest
As for the industry’s uptake since the Pfizer trial, Robertson said Exco InTouch is currently working with AstraZeneca in the clinical space developing a mechanism to help COPD sufferers manage their condition.
Furthermore, he told us the firm has preferred provider relationships with a number of top ten pharma, as well as contract research organisations (CROs). He said: “Because we’re a niche technology provider we can add something to the CRO solution that perhaps they don’t have in-house and it actually gives them an innovative addition to their product suite.”