But pharma company admits to disappointment with patient recruitment to REMOTE study
Pfizer has vowed to continue to use social media and the internet to boost patient recruitment rates in its clinical trials despite the failure of a 'virtual' study pilot.
The REMOTE trial of Pfizer's overactive bladder drug Detrol LA (tolterodine tartrate) began recruiting last year with the aim of attracting 600 patients from 10 states across the US.
Dubbed a 'trial in a box', it was the first randomised clinical trial that patients could participate in entirely from home - regardless of where, or how close to clinical sites, they lived – by using mobile phone and web-based technology.
The hope was this approach would save time, produce better data and increase patient compliance, but earlier this year the trial was halted after Pfizer failed to persuade sufficient numbers of patients to take part.
Head of clinical innovation Craig Lipset acknowledged the company had been “disappointed with the rate of on-line patient recruitment in the current trial.”
But writing on company's Think Science blog he was adamant that setbacks with the trial would not stop Pfizer from using online or social media channels in clinical trials.
“This project does not represent a failure for, or withdrawal from, the use of the internet or social media for patient recruitment. We routinely use the internet as a channel for recruitment in our studies and will continue to do so wherever it is appropriate,” he said.
So, what went wrong with the REMOTE trial? One element seems to be that the company was trying to do too much, too fast.
“We were testing a number of modules at once: online recruitment, screening, and consent; at-home study drug delivery; mobile- and web-based tools for all data reporting; online identity verification; a centralised investigator site,” Lipset explained.
But this hasn't damped Pfizer's enthusiasm for trying to make this approach to clinical trials work and the door is still very much open for another virtual study, with a European version understood to be under consideration.
“Recruitment strategies tend to be very study-specific, and we will be working to refine such strategies specific to a virtual trial approach,” he wrote.
And although the trial stumbled when it came to patient recruitment, other parts of the trial “worked very well,” according to Lipset, who said Pfizer would gain “near-term value for the REMOTE investment.”
In particular this is likely to come from the lessons learned in areas such as online consent delivery and testing, in-home patient follow-up, expanded use of mobile and at-home drug delivery, and applying them to future trials.
“As we wind-down the current pilot, we are also re-evaluating our path for patient education and engagement to are looking to re-launch in 2013. We believe improved support and engagement with trusted healthcare providers could be an important part of that solution,” Lipset said.