Clinical development news in brief

Algorithme enters Europe via Wales​

Canadian contract research organisation Algorithme Pharma has taken over Simbec Research, an early-phase specialist based in Wales. The deal represents the first foray into the European market for the Phase I-II trials specialist, which also bought a clinical research unit in Baltimore, US last month.“Given the considerable growth of our ‘international’ clientele, it became necessary to acquire a location in Europe in order to better serve our fast-growing market once we had expanded to the US​,” said president and CEO Louis Caillé.

Medical Device CRO looks Stateside​

Factory CRO, a Netherlands-based firm specialising in regulatory trials for medical devices, has tapped AmeriStart for sales, marketing and business-development support. Under the terms of the agreement agreement, AmeriStart will promote Factory CRO’s clinical research capabilities to the North American medical device market. Financial terms of the agreement weren’t disclosed.

“Our team of experienced physicians, clinicians and medical-device professionals has, over the past 20 years, conducted clinical studies for more than 50 American medical-device manufacturers​,” said Dirk Meijer, CEO of Factory CRO. “Now, with a representative office and AmeriStart’s organisational support, we hope to expand and improve our standing in the US marketplace​.”

Boost for UK clinical trial sector​

Two universities in the West Midlands of the UK, Birmingham and Warwick, are to receive just under £10m (€12.3m) apiece in order to advance their preclinical research projects into clinical testing. The government funding has come from the West Midlands Regional Development Agency.

Warwick University will use the money to set up a dedicated clinical trials unit, while Birmingham will invest in a refurbishment of its existing clinical infrastructure. Other projects include the development of a dedicated human tissue biorepository at Birmingham, the refurbishment of laboratories at Warwick, and the creation of a mobile clinical trials which will visit regional GP surgeries and hospitals where facilities for clinical research do not currently exist.

A new way to test cancer drugs​

UK researchers have propose a novel multi-arm trial design that can test several therapies simultaneously and could speed drug development in cancer, which despite major advances in understanding has not seem a dramatic hike in new patients reaching patients, in part because of the time required for clinical testing.

Mahesh Parmar of the Medical Research Council Clinical Trials Unit in London and colleagues modified standard clinical trial methodology so that multiple therapies or combinations can be compared in a single trial, known as Multi-Arm, Multi-Stage (MAMS). The new design combines standard Phase II and Phase III goals into a single trial and requires fewer patients than standard trials. The research is available here​.

Pharmatech sees demand for just-in-time trials​

Denver, US-based research management organisation Pharmatech has signed up five more pharmaceutical companies to its just-in-time clinical trial concept, which it claims will revolutionise studies involving diseases with small patient numbers.

At the moment, the clinical research process involves lengthy time spans between collecting the documentation needed for institutional review board approval and identification of a potential patient. Sometimes this drawn-out process never results in the identification of an eligible patient, particularly in cases of rare disease indications where time is most critical.

Using the just-in-time approach, the study sponsor does not open the trial at the site level until a potential patient is identified through basic standard of care procedures. This “saves time, money, and effort for both the sites and the sponsors​,” according to Pharmatech. Patient enrollment is also increased because a protocol can be rolled out to a large number of qualified research network sites with minimal expense of time and capital, it claims.

Outsourcing Clinical Trials opens doors in Belarus​

Russian CRO Outsourcing Clinical Trials (OCT) is strengthening its position in eastern Europe with the opening of its new office in Minsk, Belarus, to add to its existing presence in Russia, Ukraine, Bulgaria and the Baltic states.

The company said Belarus was an important country for clinical research because there is as yet little competition for patient recruitment trials, a relatively high population of about 10 million people that tends to be concentrated in big cities, plus a centralised healthcare system and large therapeutic hospitals.

In other news, OCT said it had just won a contract for a 60-patient trial in diabetes, which will take place at six clinical sites in Russia.