Pierre Fabre deploys biosensors to enrich clinical trial data
The aim is to provide detailed and accurate monitoring of a patient's physiology - including pH, temperature and blood glucose levels - as well as to measure the levels of an administered drug in the body more accurately.
French drugmaker Pierre Fabre is using chips developed at the Swiss Federal Institute of Technology in Lausanne (EPFL), which are implanted under the skin and remotely powered using a patch applied to the skin, which also serves to relay data to a mobile phone.
Proof-of-concept trial
The technology is being deployed in the first instance in a proof-of-concept trial involving a candidate drug for acute schizophrenia episodes - called F17464 - which Pierre Fabre is currently testing in a phase II trial. Results are expected in 2016.
"Knowing precisely and in real time the effect of drugs on the body is critical to personalised medicine and the accuracy expected in tomorrow's world," commented EPFL's Dr. Sandro Carrara, who is working on the Pierre Fabre project.
Using biosensors could make it possible to determine more quickly whether a drug candidate should continue in development - potentially avoiding wasted R&D investment - and reduce costs by allowing shorter, smaller trials.
"The use of biosensor chips in clinical studies is an innovative project whose success would boost the development of effective and safe new molecules for patients," commented Dr. Lawrence Audoly, Pierre Fabre's R&D director.
GSK collaboration
If effective, they could also be deployed after a drug reaches the market in order to monitor patient responses to treatment, so it is unsurprising that drugmakers have started to look closely at the technology.
Other companies investigating the use of biosensors to extract more information from trials include GlaxoSmithKline (GSK), which has teamed up with Formula One firm McLaren and Medidata on a number of 'big data' projects, including the development of wearable and remote sensors for use in clinical research.
The collaboration draws on Mclaren's experience with in-car diagnostics technology that captures more than a billion data points over the course of a Grand Prix weekend.
ERT wearable biosensor
Meanwhile, clinical data specialist ERT presented a paper at this year's Drug Information Association (DIA) annual meeting on a wearable biosensor which captures and wirelessly transmits real-time, biometric measurements including electrocardiogram (ECG), respiratory rate, heart rate, heart rate variability, skin temperature, physical activity, posture and fall detection.
To test the device, ERT captured fall detection data from the patch and used it to update an electronic diary that captured information about the circumstances surrounding the fall.
Now, clinical data is already starting to appear. Earlier this month, a team of clinicians at Cedars-Sinai Health System in the US reported the results of a pilot study in rheumatoid arthritis (RA) patients which used wearable sensors - including an ankle device incorporating a gyroscope - to determine the mobility of patients on biologic drug therapy.
The sensors were able to give investigators a view of the mobility of patients with RA and revealed some interesting findings. For example it was found that one patient taking the active drug Enbrel (etanercept) showed dramatically reduce d mobility - a confounding result until the investigators realised the drug was allowing her to return to work sitting at a PC for long periods.
