A Sanofi-backed consortium has won clearance to run a virtual diabetes trial in Europe. The regulatory nod reportedly marks the first time European authorities have green-lit a clinical trial with full electronic informed consent.
The FDA has requested $2 million in President Obama's 2016 budget to build precision medicine-related IT infrastructure. The regulator highlighted cloud computing and data security as areas in which it needs to improve.
The clinical trial data transparency movement was propelled forward by two major developments this week. On the same day, influential national academy the Institute of Medicine called for more systematic sharing of trial results and Johnson & Johnson agreed to extend its transparency initiative to include medical devices and diagnostics.
Novartis has added another component to its "Clinical Trials of the Future" program. The latest element of the trial efficiency initiative sees the Swiss Big Pharma team up with computer chip maker Qualcomm to gather data on clinical trial participants between visits to the investigator site.
The FDA has released a list of almost 100 draft drug guidance documents it plans to introduce or update in 2015. The documents cover a range of biotech IT-related topics, including electronic informed consent in clinical trials, links to third-party sites in social media adverts and statistical approaches to showing biosimilarity.
GlaxoSmithKline and Medidata have moved mHealth tools one step closer to the clinical trial mainstream. Having run a pilot project, the partners have concluded that mHealth technologies can deliver reliable, FDA-compliant data and improve the clinical trial experience for patients.
Thermo Fisher Scientific has confirmed its Kinetica software will generate inaccurate results when analyzing unbalanced clinical trials, Reuters reports.
In the years since the Affordable Care Act birthed the Patient-Centered Outcomes Research Institute, the group has committed resources to lowering barriers between those who participate in and run clinical trials. The latest element of this initiative has now come to fruition, with PCORI naming PatientPowered.us as the winner of its Matchmaking App Challenge.
The U.S. National Cancer Institute is working with Dell, Terascala and the Translational Genomics Research Institute to bolster its pediatric oncology research capabilities. The NCI ultimately hopes to use the new computing capabilities to discover new biomarkers and therapeutic targets for childhood cancers.
The study aims to recruit 40 people in the United Kingdom to wear watch-sized sensors on their belts. By placing the sensors around the body's center of mass the team from Imperial College London hope to gather data on each individual's position and walking speed.