As medical device regulations evolve and global, multi-center studies become increasingly common, a growing number of sponsors are turning to independent committees such as Data Monitoring Committees (DMCs) or Clinical Endpoint Committees (CECs) for assistance with clinical trial oversight. However,...
Premier Research
Months before Britons voted narrowly to leave the European Union (EU) in June 2016, then-U.K. Prime Minister David Cameron called a vote to withdraw from “the gamble of the century” and warned of dire political and economic repercussions. More than...
Since 2002, doctors and researchers have used a standard rosacea classification system to provide consistent terminology as well as to facilitate studies, clinical diagnosis, and treatment. However, in 2018, the Journal of the American Academy of Dermatology published a new...
We were conducting a trial for a painful diabetic neuropathy (PDN) drug and were investigating why one site had an especially high placebo response rate. Then one of our representatives, waiting in the site’s lobby to meet with the principal...
Between 7 and 10 percent of the U.S. population suffers from some type of neuropathic pain, and a significant share of those affected require chronic pain treatment.1 This high rate of occurrence makes our limited understanding of these afflictions, and...
In 1976, pop culture icon John Travolta starred in the made-for-television movie The Boy in the Plastic Bubble about a young man with a compromised immune system. The premise of the film is that Travolta’s character has to decide between...
To get a successful return on investment (ROI) for your product, it is essential to establish early in the process: Is there an unmet need for the product? Which attributes will the product need to access the market? Will providers...
One of the tenets of the FDA is to get safe and effective drugs to market as soon as possible. To expedite approval of products for which there is the greatest clinical need, the FDA offers four expedited programs to...
Medical Device
Demystifying the Differences Between DMCs and CECs
In a clinical trial landscape where global, multi-center studies have become increasingly common, trial monitoring has become more complex. Regulations require that sponsors of medical device studies perform site monitoring to ensure that investigators are compliant with federal regulations, sponsor...
While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials are designed and executed....