When it comes to study data, not everything can be easily measured and reflected by numbers. In a recent trial of a new occluder device for transcatheter closure of secundum atrial septal defects, the primary efficacy endpoint of defect closure was easy to measure in millimeters of possible residual shunt. However, assessment of the safety...
This week’s Tales from the Road is from Angi Robison, Executive Director, Strategic Development Department, Rare Disease & Pediatrics, who gives us a bit about what she took away from the World Congress Patient Advocacy Summit back in October. Greetings from the road! I just had an excellent two days at the World Congress Patient Advocacy...
Virtual Reality’s mainstream use in clinical research is no longer a fantasy. At the recent National Institutes of Health (NIH) Research Festival in America’s capital, attending clinical researchers were encouraged to strap on head-mounted virtual reality (VR) devices and image how they might enhance their clinical and basic research. The NIH even showcased its Virtual...
When it comes to study data, not everything can be easily measured and reflected by numbers. In a recent trial of a new occluder device for transcatheter closure of secundum atrial septal defects, the primary efficacy endpoint of defect closure was easy to measure in millimeters of possible residual shunt. However, assessment of the safety...
DURHAM, N.C., OCTOBER 3, 2016 — You’re starting a lengthy project that’s fraught with risk and could cost a billion dollars or more to complete. A couple of early missteps might spell disaster. Welcome to clinical drug research. Boost your odds of success with a robust project schedule and carefully executed startup plan. At MAGI’s...
There are more than 7,000 known rare diseases, and these conditions afflict an estimated 30 million Americans (almost one in 10). Worldwide, some 350 million are living with a rare disease. But for 95 percent of these conditions, there are no FDA-approved treatments — not one. Conventional wisdom holds that innovation follows need: that if...
DURHAM, N.C., August 10, 2016 — Patient advocacy groups play an important and growing role in developing drugs to treat cancer and rare diseases, contributing to study design, recruiting patients, and even directly funding clinical trials. At a September webinar, Premier Research will team with rare disease advocacy organization Global Genes to explore this important...
The challenges of greater regulatory scrutiny, complex logistics, downward cost pressure and increasingly rigorous data requirements are just a few of the reasons biotech and pharmaceutical companies look to outsource clinical trials. In a dynamic healthcare and regulatory environment, outsourcing increases flexibility by streamlining clinical trial management and enabling sponsors to concentrate their resources on...
For a fertility study, we needed to recruit young women who had had at least three unexplained miscarriagesand who were currently trying to conceive. The field of prospective recruits was huge: all women 18 to 37 years old living in the United Kingdom. The challenge: cost-effectively reach, screen, and randomize 150 patients. The solution: motivate...