IsoRay (NYSE:ISR) is facing putative class-action lawsuits from shareholders accusing the company of making false or misleading statements about a clinical trial of its Cesium 131 brachytherapy seeds designed to treat cancer. The lawsuits, from at least 3 different shareholders, claim that IsoRay made false statements about a clinical study of Cesium 131. The study was the 1st […]
Clinical Trials
Augmenix touts publication of pivotal SpaceOar study
Augmenix said last week that a pivotal study of its SpaceOar system was published online in the International Journal of Radiation Oncology•Biology•Physics. The 222-patient pivotal study was designed to evaluate safety and efficacy of the SpaceOar System in men undergoing prostate radiotherapy, the company said. The SpaceOar is designed to separate the prostate from the rectal wall during radiation […]
St. Jude Medical touts early results for Axium neurostim device
St. Jude Medical (NYSE:STJ) said Monday that a study of its Axium dorsal root ganglion neurostimulator showed superior pain relief compared to traditional spinal cord stimulation in treating chronic lower limb pain associated with complex regional pain syndrome. The the 152-patient Accurate study reported that 81.2% of patients treated with the Axium system achieved significant pain […]
Stimwave wins nod from FDA for IDE trial
Stimwave Technologies said yesterday it won FDA investigational device exemption clearance to test an 8-electrode version of its wireless miniature neurostimulator device for the relief of chronic back and leg pain. Miami, Fl.-based Stimwave said the FDA also approved a study of the device using high frequency treatments through an external pulse generator. “This study […]
TAVI: St. Jude Medical can resume Portico trial
St. Jude Medical (NYSE:STJ), which paused implantations of its Portico replacement heart valve last fall out of an abundance of caution, won the FDA’s approval to resume U.S. implants of the device in a clinical trial, the company said yesterday. Back in September 2014, St. Jude said CT scans turned up a potential problem with the Portico valves in […]
Positive early data for Valtech’s Cardioband
A trial of Valtech Cardio‘s Cardioband transcatheter annuloplasty system showed no device-related mortality, with decreases in mitral regurgitation and septo-lateral dimension. Results from the 40-patient multicenter observational study, designed to evaluate the safety and performance of the Cardioband, were presented this week at the European Society of Cardiology’s annual meeting in Paris. The study was […]
Creating a compliant, lock-tight site budget for clinical trials
By Kathi Shah, MS, MBA
Creating a clinical trial site budget sounds simple right? A Sponsor contracts with an investigative site to conduct a clinical trial per the protocol. The Investigative site is compensated by the Sponsor to conduct the services outlined in the protocol. The relationship between the Sponsor and Investigative site is heavily weighted on the budget developed to compensate sites for their efforts to conduct the study.
FDA guidance outlines principles for adaptive design in device clinical trials
By Stewart Eisenhart, Emergo Group
New draft guidance from the US Food and Drug Administration lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued data while maintaining study validity and integrity.
Progress on clinical trials and demographic information | Regulatory news for the week of February 23, 2015
Recent progress on demographic information and clinical trials
By Barbara D. Buch, M.D.
At FDA, one of our foremost responsibilities is to evaluate and if medical products meets the appropriate standard, to approve or clear drugs, biological products and medical devices. We know that these products are safer and more effective for everyone when they are tested in clinical trials that include diverse populations.
A CDRH Priority: Clinical Trials in the U.S.
Owen Faris, Ph.D., Clinical Trials Director (acting), Office of Device Evaluation in FDA’s Center for Devices and Radiological Health
By Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D.
At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but that also present the greatest risk to patients.
