Pfizer has begun what it claims is the world’s first ‘virtual’ trial and says that such innovation is needed to make sure clinical research is sustainable.
The REMOTE trial, which is designed to assess Pfizer’s drug Detrol LA as a treatment for overactive bladder (OAB), uses mobile phone and web tech to record data from participants remotely rather than at clinics.
Data from the virtual study will be compared with those from two previous trials, A0221008 and A0221046 , which used traditional clinic-based reporting protocols to see if the results can be replicated.
Pfizer spokesman Andrew Widger told Outsourcing-pharma.com that, if successful, the participatory patient-centred (PPC) model could offer considerable financial benefits.
“One significant area will be a decrease in the cost of monitoring visits, which can represent as much as 50-75 per cent of a study budget.
“Another significant cost factor for clinical trials is the set up cost for actual trial sites and the maintenance cost for sites that are recruiting no or very few patients. Again the single site concept may reduce these costs significantly.”
As yet the virtual protocol has only been approved by the US Food and Drug Administration (FDA) but, according to Widger, Pfizer has “started to develop a similar model to be implemented in Europe in the near future.”
He went on to suggest that, in some trials, participants could take part entirely from home, while in other studies certain aspects of the PPC approach could be employed.
“Modules from the PPC methodology may also be used in conventional “brick-and-mortar” trials – such as online consent, remote drug shipment, or use of mobile and telemedicine – to introduce incremental efficiencies to different studies.”
Clinical trial change
Widger also believes the PPC model and the cost efficiencies it offers could be important to the future of drug research, suggesting that: “For clinical trials to be sustainable in the future there must be change”
“As the future of healthcare evolves, including further proliferation of electronic health records and consumers that are actively involved in managing their health information, the PPC model may continue to evolve, relying less on patients to self-report data and increasingly allowing patients to authorize and share their trusted health information.
“The model will also enable new roles for treating physicians to participate in research studies with their patients, with the responsibilities of the investigator centralized by this virtual approach.”