Companies explore gathering clinical trial data with “wearables”
Remote Data Collection
The use of remote sensors, carried offsite by study subjects as “wearables,” and the merging of the resulting data into one coherent stream for analysis has long been desirable but has proven difficult to achieve.
Pfizer was the first to try using remote wearable sensors for clinical studies in 2011. Pfizer’s REMOTE system used cyber technology exclusively to gather trial data. The effort was halted a year later due to a lack of participants.
Technologies have grown and changed dramatically in the 6 intervening years. Digital devices and online services have become easier to use and more readily available. All of the right factors have aligned to encourage the industry to revisit the idea.
Now, according to Angus Liu in Fierce Biotech (June 16, 2017), two companies have begun another attempt at successful data gathering with remote sensors. Soon-to-be bought out Parexel, with the participation of French pharmaceutical company Sanofi, began a “Patient Sensor” study in March using its “Perceptive My Trials” system, a cloud-based clinical trial management platform that can gather, transmit and meld data.
“We believe the use of wearables to collect data from trial participants represents a breakthrough in the digital transformation within the industry,” said Xavier Flinois, president of Parexel Informatics. “Working with Sanofi, we believe we have a strong opportunity to streamline and automate data collection from multiple devices, collect high-quality data remotely and generate meaningful results, all while reducing burden on patients and sites, as well as lowering costs.”
Lionel Bascles, clinical science and global operations head at Sanofi, added, “Our objective is to demonstrate the relevance of data collected remotely and the overall feasibility of utilizing wearables in clinical trials. Wearables are a core component of Sanofi’s digital trials strategy and represent an important approach to automate patient processes using the latest technologies to bring new therapies to patients sooner. We are pleased to be collaborating with Parexel and leveraging its multifunctional expertise in this area. We are committed to further advancing the potential of this technology.”
The two companies are well positioned for making another attempt at this promising but technologically and logistically difficult challenge. Parexel International Corporation provides clinical research, medical communications and technology consulting to the pharmaceutical, biotech and therapeutic device industries. It runs clinical trials and consults on development, regulatory and reimbursement issues.
Sanofi is a biomedical company with a worldwide reach involved in vaccines, immunology, oncology, diabetes and cardiovascular research. Partnering with two UK firms, eClinicalHealth and Langland, as well as the Finnish healthcare tech firm Mendor, Sanofi carried out a study called VERKKO, which monitored the performance of a 3G-enabled wireless blood glucose meter in remote operations in a clinical trial, which has direct relevance to its effort with Parexel.
Parexel is the latest CRO to be bought up. Pamplona Capital Management will be buying Parexel for $88.10 a share in cash, which works out to be about $5 billion (including debt). Parexel will become a private company under the deal and no longer be listed on any public market.