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Building a successful electronic data capture (EDC) program starts with building a good support infrastructure, said Megan Gassert, global training manager at Procter & Gamble's (P&G) EDC support services.
The European Union recently implemented the EU Clinical Trials Directive (CTD) to better protect clinical trial participants while streamlining the bureaucracy to make the EU more attractive for clinical research (CTA, Nov. 17, Page 1).
Startup and training costs have sapped some of Amgen's cost savings potential, but the company remains bullish on electronic data capture (EDC) in its clinical trials as it ramps up its program, said clinical data management manager Kevin Reidy at a conference sponsored by the Center for Business Intelligence in Philadelphia.
The ethical considerations about so-called “non-consent” trials on a blood substitute called PolyHeme have ignited a storm of controversy in recent weeks initiated by Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee.
While senior executive buy-in is critical, one of the most important drivers of any new eclinical initiative is finding and advancing a “project champion,” said a project management veteran at a recent industry conference in Philadelphia.
The FDA’s Critical Path Opportunities List, unveiled March 16, focuses on projects intended to streamline clinical trials and advance the use of biomarkers.
Methods for collecting adverse-event data differ among trials, making it difficult for clinicians to compare risk-benefit profiles, claims a research team from the San Francisco Veterans Administration Medical Center.
AstraZeneca has announced results from a study that show its cholesterol-lowering drug Crestor reversed atherosclerosis — plaque buildup in the arteries of patients with symptoms of coronary artery disease.
Merck has released a study that shows Vytorin, a cholesterol-lowering combination drug marketed by Merck and Schering-Plough, is more effective than Merck’s stand-alone drug Zocor.
A critical mass is looming on the horizon that will see an explosion of electronic data capture (EDC) adoption in clinical trials of all shapes and sizes, experts and surveys suggest.