Two announcements from opposite sides of the Atlantic have underlined the importance of contract research organisations (CRO) and other players in the sector investing in new imaging technology to improve diagnoses both in the course of clinical trials and as an aid to patient recruitment.

US-based CRO Kendle has exclusively licensed Brain Network Activation (BNA) imaging technology for its early-stage development activities from EIMindA, a medical technology development company with headquarters in Herzliya, Israel. The technology provides a non-invasive platform for mapping, monitoring and understanding brain electro-physiological network activity in response to cognitive or physiological stimuli.

The BNA solution reveals electrophysiological neural networks using an innovative set of signal processing and pattern recognition techniques that combine the high temporal resolution of electroencephalography (EEG) with the spatial resolution of functional magnetic resonance imaging (fMRI), Kendle explained.

This produces a three-dimensional image of neuronal connectivity and synchronisation, with “sensitive, specific and reproducible data” on drug effects essential for early stage development.

“This technology represents a sizeable step forward in our ability to evaluate the effectiveness of CNS drugs early in their development by directly and objectively observing the brain’s response to them,” commented Dr Ed Sellers, vice president, early stage for Kendle.

BNA is faster, less expensive and more accessible than other brain imaging solutions currently on the market “because all scanning can be done in house”, Sellers added. “Ultimately this translates into powerful, abundant data and expedited go/no-go decisions for our customers, saving them time and money.”

The technology is expected to accelerate research in key areas such as Alzheimer’s disease, mild cognitive impairment, schizophrenia, pain, attention deficit hyperactivity disorder, depression, anxiety, sleep disorders and narcolepsy.

It can be adapted to any study of drugs expected to act on the central nervous system, Kendle noted. The BNA platform is immediately available to customers through the company’s early- stage units in Toronto, Canada and Utrecht, the Netherlands.

The Doppler effect

Synexus, the UK-based company that recruits for and runs clinical trials at its own research centres in nine markets worldwide, has invested in Doppler Ultrasound equipment for each of its seven Dedicated Research Centres in its home market.

The Doppler equipment will be used to confirm diagnoses of peripheral artery disease (PAD) in patients with type 2 diabetes – specifically as part of a drive to recruit patients for a new diabetes study.

“We are all acutely aware of the challenges in recruiting patients to UK-based studies quickly and cost-effectively,” commented Angela Harnick, Synexus’ head of UK operations. “As with our previous investment in DXA scanners, this one is designed to help us recruit the right patients as quickly as possible and to give our project team and investigators better control over volumes and timings.”

General practitioners in the UK do not generally have access to Doppler ultrasound and have to refer patients to a specialist consultant for the PAD test, which can involve waiting several weeks before a confirmed diagnosis can be made and treatment started, Synexus pointed out. GPs working with the company to help recruit patients for its diabetes trial will be able to offer the Doppler test within a matter of days.

“We need to take action that makes joining a clinical trial more attractive to patients and we need to show GPs that we really can make a difference to their patients by delivering faster diagnoses and first-class medical care whilst their patients are part of our studies,” said chief executive Michael Fort.

“At Synexus we continue to buck the trend against clinical trials recruitment in the UK,” he added. Between 2005 and 2009, the company has boosted from 1,000 to more than 5,000 the number of patients it has enrolled for clinical trials in the domestic market, Fort noted.