Roche and its biotechnology division in California, Genentech, failed to report or analyze approximately 103,000 adverse events and 15,000 deaths. In an apparent breach of regulations on both sides of the Atlantic, the firm had been supplying needy patients with treatment on compassionate grounds but never processed any of the associated data. "Possible side-effects picked up by the patient support program were not sent to Roche's own database for evaluation and therefore never made it to health officials, according to spokesman Daniel Grotzky," according to one news story. Here's another. International regulatory agencies are looking into the matter. The lapse was discovered in a routine regulatory inspection.
Quintiles inked a software deal with Allscripts. The two companies will combine algorithms and health data to model post-market surveillance, patient recruitment and site monitoring, among other clinical R&D challenges. In the press release, Steven Schwartz, senior VP of corporate business development for Allscripts, said: “This is another groundbreaking step in using the new kinds of clinical information we are gathering from electronic health records (EHR) to improve patient health outcomes.”
Janssen's biotechnology division is applying to European and U.S. authorities for golimumab (Simponi) in patients with severe ulcerative colitis. First approved in 2009, the drug is a monoclonal antibody. The company's recent Pursuit trial used an adaptive biostatistical design. Said Jerome Boscia, Jannsen's VP and head of immunology development: "We look forward to collaborating with the health authorities on these submissions."
SGS Life Sciences selected the Phase I component of the Oracle clinical trial suite, which is called LabPas. The contract research organization cited the software's ability to accelerate sample management, subject recruitment and data capture. “The solution will enable us to capture and share real-time data with sponsors throughout a study, to streamline clinical processes and facilitate more rapid insight, so staff and sponsors can operate more efficiently to increase the productivity of early phase studies,” said Omer Van Schoor, Antwerp clinical pharmacology unit director at SGS.
Medical device firm TriReme, based in Singapore and Pleasanton, California, selected the OpenClinica electronic data capture (EDC) platform. “OpenClinica’s flexible model makes it easy for us obtain a regulatory compliant environment in which to collect and manage data for our pivotal clinical research,” said Erin Tims, associate director, clinical affairs. Here's a news story.
The New York Times got attention this week for an ongoing story about the FDA spying on a handful of its own employees. (An imaging device product approval decision was internally disputed.) For the armchair lawyers out among our readers, it appears that some FDA surveillance of its own staff is perfectly legal and kosher; some is not. The FDA's IT security folks watched emails, snapped screenshots and examined what was carried home on those ubiqutious USB "thumb" data storage drives. The matter is now being litigated and politicized in the usual way. The geek website Ars Technica beat the New York newspaper to cover the story by six months or so. The Ars Technica story more clearly illuminates the plaintiffs' role in seeking publicity for their cause.