Clinical Trials Advisor

While the 2010 Affordable Care Act (ACA) is generally a revenue boon for drugmakers, the law presents pricing and formulary pressures that will force companies to steer toward less-saturated disease areas and better show the value of their products, experts say.

Clinical trials for new diabetes treatments must focus on their long-term and cardiovascular safety, according to an updated European Medicines Agency (EMA) guideline.

UK sponsors of Phase I clinical trials should take out adequate insurance policies in order to accelerate ethics committee review processes and assure volunteers they will be compensated for an injury or adverse event suffered as a result of the study, according to a new industry best practice guideline.

Sites dealing with physician concerns about patient poaching may want to take a page from site director Steve Kenney.

To find out whether a drug works sooner, sponsors should utilize enrichment approaches to clinical trials, CDER’s Deputy Center Director for Clinical Science Robert Temple says.

The FDA is taking a hard look at requirements for clinical trials of hospital blood glucose sensors in hopes of speeding their availability in the U.S. over the next several years, agency officials said during a recent public hearing on the devices.

The FDA has warned the IRB at a large Illinois healthcare system for enrolling emergency room patients in a clinical trial without their permission.

A panel of FDA advisors called for swift approval of Genentech’s Lucentis for diabetic macular edema (DME), saying statistical shortcomings of the sponsor’s supplemental biologics license application (sBLA) are far outweighed by the drug’s efficacy and safety profile.

At least five large pharmaceutical companies are developing new cholesterol treatments that aim to compete with blockbuster statins and reduce cardiovascular risks.

The FDA needs to insist on more quality data in medical device 510(k) premarket notification and premarket approval (PMA) applications and provide real-time postmarket surveillance data that is transparent, Rita Redberg, chief editor of the Archives of Internal Medicine and professor of medicine at the University of California, San Francisco, told the 2012 PharmedOut Conference in Washington, D.C.

Transparency will be the hallmark of the Physicians Payment Sunshine Act, part of the 2010 Affordable Care Act, healthcare compliance experts say.