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For biopharmaceutical companies looking to streamline the clinical trial process, “big data” can be a big challenge. From complex genomics to the constant stream of patient data from mobile sensors and devices, the information supporting a modern clinical trial is enormous. Managing this information can seem daunting; simply capturing and analyzing it has the potential to slow down a trial and introduce errors as more and more partners are required for a complex trial.
Yet certain data is vital to the process of bringing a new treatment to patients, and in fact can lead to a far greater understanding of how well the treatment might work for a given patient, or even how it might be studied to treat an entirely different condition. So companies are seeking solutions to this challenge by turning to new advances in technology.
From sophisticated data analysis to the creation of industry standards for sharing information between companies and trial sites, Sanofi and other pharma companies are applying technology to streamline how they work with information.
“The biopharma industry needs to be ahead of the curve when it comes to adopting new digital technologies,” said Karri Venn, President, LMC Manna Research, a large clinical research site network working closely with Sanofi. “It’s important that companies like Sanofi have been agile in trying new approaches.”
The application of technology involves areas like patient recruiting, where social media along with analytics can help proactively identify and engage a larger number of potential study participants. Mobile sensors that produce vast amounts of information also make it possible to operate “virtual” clinical studies, which is the focus of Sanofi’s collaboration with Science 37, a mobile technology and clinical trial company. Unlike traditional trials in which participants travel to the trial site for clinical evaluations, they can instead be monitored from home, which makes study participation more accessible and ultimately reduces study timelines.
Sanofi has also begun using technology to identify the research centers to involve in its studies. Through collaborations with TriNetX, a global health research network that optimizes clinical research and creates real-world evidence and InSite, the largest European live clinical data network, Sanofi uses data from the growing database of electronic health records to identify sites for new trials that already treat high numbers of patients who meet the study eligibility criteria.
Advancing Industry Standards
In addition to the data challenges of individual studies, clinical research sites themselves often simultaneously support many studies sponsored by a variety of biopharma companies. Not only does that multiply the data load, but traditionally each sponsor creates its own protocols for training, organization and data collection that must be learned by the research site staff. That introduces inefficiencies into a process that could be standardized.
Seeking to do just that, Sanofi has partnered across the industry through an organization called TransCelerate, which has an initiative underway to advance the use of a common template protocol. Working off a standard template means site instructions for key processes, such as safety event reporting, are in the same location of each study protocol regardless of the company sponsoring the trial
“Advancing industry standards is key to reducing the burden medical research sites face across clinical trials,” said Kelly Simcox, head of the Americas Clinical Study Unit at Sanofi. “We invest significant effort on standards that enable cross-industry benefits. Most importantly, this work will help clinicians spend more time with their patients.”
Sanofi and other TransCelerate members are also making progress on an integrated portal, in which multiple companies can share clinical study information with research sites via a secure, confidential single platform. This approach means research staff won’t have to use (and learn) different portal technology systems for each of the sponsors.
As the industry looks to reduce the potential time from discoveries to medicines, one thing is clear: it will take the combined efforts of both companies and clinical research sites to keep making progress.
Sanofi remains focused on joining with industry consortia and clinical sites to accelerate clinical trials for the benefit of patients.
“Positive relationships are a two-way street,” said Venn. “Pharma companies can use our feedback, and for those open to change, we can form true partnerships that make a tangible difference in improving the experiences and outcomes for our patients.”