A study published Sept. 29 in The Journal of the American Medical Association concluded that publicly available information to support the safety and effectiveness of implanted, 510(k)-cleared devices is lacking.
The federal Patient-Centered Outcomes Research Institute added three medical device-related topics to its list of priority research areas that are eligible for enhanced funding under the Pragmatic Clinical Studies initiative. In the new funding round, comparative trials studying cardiology, hip fracture and surgical mesh are invited to apply.
A Wall Street Journal feature this week on researchers' long-standing concerns about the consequences of patients talking about clinical trials online digs into how biopharma companies are tapping technology to counter concerns about unblinding and manipulating inclusion/exclusion criteria.
Tonix Pharmaceuticals has completed enrollment in the 200-patient, placebo-controlled BESTFIT trial of sublingually delivered cyclobenzaprine for the treatment of fibromyalgia.
In a 1993 clinical trial of fialuridine--a drug originally designed as a therapy for hepatitis B--5 out of 15 patients died from sudden liver failure. A new study in PLOS Medicine found that mice with humanized livers demonstrate the drug's toxicity.
Every clinical trial has its outliers. Some patients respond far better to the treatment than the rest, but the focus on efficacy across the study population means these results--and their implications--are lost in the shuffle. The National Cancer Institute is trying to change this by improving the tracking of data on these "exceptional responders."
While it is years now since clinical trial participants started talking about their experiences online, the industry is still searching for the best way to approach the phenomenon. And with pharma needing to improve the clinical trial process, the onus is on the industry to find systems that not only manage the negative implications of social media, but tap into its power, too.
The European campaign for greater clinical trial data transparency faced a big test this week when the region's politicians voted on legislation. More than 95% voted in favor of the regulations, paving the way for the creation of a publicly-accessible database of clinical trial results.
Johnson & Johnson was cautiously lauded for its clinical trial data-sharing initiative, but Roche's project was pilloried. Now Novartis has joined its Swiss peer in rolling out an underwhelming transparency program.
Clinical trial data collection has evolved slowly over the past two decades from site visits and paper questionnaires to telemedicine and electronic patient reported outcomes. The transition is far from complete though, with the likes of CamNtech and Medidata now looking to bring wearable computers to clinical trials.