inVentiv Health, the US-based provider of clinical development, commercialisation and consulting services, is tapping into new tools to streamline the set-up and execution of clinical trials by taking a “significant” equity stake in clinical technology and services specialist Mytrus.
The California firm’s core platform is a digitised process for home-based informed consent, including an application for iPads and other tablets that that uses animation and other visual imagery to explain the informed-consent process to patients before they enrol in a clinical study.
Mytrus’s technology was employed in REMOTE (Research on Electronic Monitoring of OAB Treatment Experience), the pilot virtual trial launched by Pfizer in the summer of 2011 to address concerns around cost-efficiency and accessibility in clinical research by using mobile phone and web-based tools to collect data on Detrol LA (tolterodine tartrate), the company’s extended-release treatment for overactive bladder.
The pioneering study, which was endorsed by the US Food and Drug Administration, was eventually abandoned after it failed to recruit enough patients.
However, Pfizer appears to have treated REMOTE as a learning experience and has said it will take the more successful elements of the initiative – including its multimedia informed-consent process – forward into other trials.
Vote of confidence
inVentiv Health’s interest, which also includes establishing a strategic commercial relationship with Mytrus, is another vote of confidence in the virtual-trial approach.
No financial details were released on the partnership, which inVentiv said “blends our shared drive for innovation and our complementary experience from the world of high tech and clinical research”.
Electronic informed consent represents a “significant improvement in efficiency and speed” that broadens the reach of clinical research by “removing location as an obstacle to recruitment and bringing trials directly to participants in their homes”, inVentiv noted.
Direct to patient
According to Anthony Costello, co-founder and chief executive officer of Mytrus, up to 30% of clinical trials run today “could be done direct-to-patient and 100% of studies and study patients could benefit from electronic informed consent”.inVentiv Health has “the global footprint and clinical research expertise to help us bring the benefits of our technology more quickly to trial sponsors and patients worldwide”, Costello added.
With patients submitting their data remotely, sponsors can reduce the number of study sites needed to run a clinical trial by as much as 80%, the partners claimed.
