by Thomas Meek
LONDON, July 4 (APM) - Running trials remotely using online tools could offer pharma companies "massive" gains in cost and time savings, according to an expert in the field.
Kai Langel, co-founder and director, patient solutions at clinical trial consultancy eClinicalHealth, told APM in an interview on Friday that the results of the recent VERKKO trial in Scotland involving Sanofi and a new diabetes monitoring device show that aspects of remotely managing clinical trials can be scaled up to support large studies.
"If you go into mega trials which sometimes have thousands of patients, if you can run them remotely then the gains you can get from that are massive: the time savings, the cost savings are in a totally different world compared to having to start up tens of sites."
He explained further the struggles pharma companies can have setting up traditional on-the-ground trials to profile patient populations across several countries.
"In order to do it you need lots of patients to get meaningful data, and that gets very expensive, and you have to get lots of sites and it becomes very cumbersome for patients and it is also very slow to start up these trials."
Langel pointed out that not every trial is suitable for remote, online management, with the methodologies more suited to later stages where there is already an approved drug with a very low risk profile.
There are elements that can be applied to a broader range of trials, however, including online recruitment; patient engagement before after and during a trial; and remote patient management.
Langel described the VERKKO trial as the "ideal" trial to apply these methods, with eClinicalHealth teaming up with Sanofi, Langland and Mendor to study how patients with diabetes managed their condition using the Mendor Smart glucose meter, and eClinicalHealth's online Clinpal platform to give patients all the information they need for the trial without them ever meeting their doctor.
Online recruitment and remote monitoring
The partners used Facebook advertising to recruit participants, receiving 74 registrations of interest, 60 of whom were enrolled in the study, said Langel.
In something of a surprise to Langel, recruited patients were older than expected considering the technology used to recruit them. The average age of patients was 56, and several participants were 70 and older.
Study materials were sent directly in the post to participants, who then connected the wireless glucose meter with their personal Clinpal account. Patients then completed a glucose profiling protocol.
Whenever patients measured their blood glucose levels during the study using the Mendor Smart, their measurements were automatically transmitted from the device into the Clinpal system, where they were available for real-time review by the patient and doctors at the study site.
Fifty-one patients received their Mendor Smart meters and started the profiling protocol, with 46 completing the profiling process, a 9% drop-out rate. This was the same as an earlier comparator study which used more traditional study methods rather than the Clinpal system.
Patients in the Clinpal trial also completed the glucose profiling 22% faster, suggesting the online system was more efficient and convenient.
Healthcare professionals at the study site also estimated they had spent 66% less time in study coordination activities, suggesting further efficiencies.
Feedback was also positive, said Langel, with patients actively managing their disease by writing diaries and engaging with researchers by providing extra information on how the device compared with other products they had used.
"They were much more involved than in a typical trial," he said.
Langel said pharma companies still have questions about the regulatory aspects of managing clinical trials remotely, saying they are a "bit nervous" about the process.
However, he added that regulators he has spoken to are "fully supportive" of the ambitions of the new methods.
"Every regulator, every ethics committee member I have spoken with has been very supportive of supporting more patients with these kinds of methods - giving them more access, giving them more information. Nobody's said 'this is a bad idea, don't do that'."