clinical trials

Latest Headlines

Latest Headlines

Quintiles upgrades Apple ResearchKit with open source additions

Quintiles has contributed open-source enhancements to Apple's ResearchKit, adding more sophisticated application features beyond the basic three modules first introduced by Apple in March. The CRO plans to develop patient engagement ResearchKit-based apps for use in its own clinical trials with a particular focus on neurodegenerative diseases including dementia.

Intersect's steroid-releasing implant meets its endpoint in bid for expanded indication

Fierce 15 member Intersect ENT said a study of its bioabsorbable steroid-releasing sinus implant met its primary endpoint, as the company seeks to expand the indication of its drug delivery tech to include placement in the frontal sinuses, located behind the eyebrows.

Study: Few clinical trial results posted on federal website as required by law

Only 13% of clinical trials registered at ClinicalTrials.gov posted their results within one year of data collection, as required by federal law, according to a study in The New England Journal of Medicine.

Yale to enable J&J to share its device, diagnostics clinical data with external researchers

Improved access by researchers to corporate clinical trial data, much like open-source software, is expected to help facilitate a conversation between academia and the business world that could both facilitate translational research and help to validate corporate research. Yale University and Johnson & Johnson have announced the first such deal to enable external investigator access to medical device and diagnostics clinical data from J&J.

Hackers target top pharma execs for financial gain

A group of hackers is looking for information related to drug safety, clinical trials, regulatory decisions and legal issues that's significant enough to move the global financial markets--and it's raiding top pharma execs' email accounts to find it, The New York Times reports.

Study: Publicly available information about 510(k) devices' safety and effectiveness lacking

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.

Feds looking to fund clinical studies on comparative effectiveness of devices

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.

Biopharma searching for right balance in addressing social media use by trial participants

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's sublingual formulation for fibromyalgia reaches pivotal trial stage

Tonix Pharmaceuticals has completed enrollment in the 200-patient, placebo-controlled BESTFIT trial of sublingually delivered cyclobenzaprine for the treatment of fibromyalgia. 

Mouse model could have predicted drug toxicity that killed 5 in clinical trial

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.