WASHINGTON, March 30 /PRNewswire/-Following yesterday's hearing of the House Subcommittee on Oversight and Investigations, Coast IRB CEO Dan Dueber announced that his company would institute immediate and sweeping reforms. "We share Congress's objective of ensuring maximum protection for human subjects in clinical trials," said Dueber. "We are instituting comprehensive reforms to prevent recurrence of the vulnerabilities the Subcommittee brought to light," he said. "Our number one priority is the protection of human subjects."
Today, Coast is sending a written post-hearing statement to the Subcommittee for inclusion in the record. That statement lists twelve specific reforms from background checks on every sponsor of a clinical trial to the hiring of an expert consultant to revamp Coast's IRB reviews. In addition, Coast is replacing the current chair of its IRB with a new chair and explains that the reform process will be continuing in nature even after the twelve specific reforms are instituted.
The reforms Coast now institutes may one day be required by law for all IRBs if Congress enacts legislation based on the Subcommittee's deliberations. "For Coast, this process of reform is not going to end," said Dueber. "We mean for it to be continuous, making reexamination and improvement a dynamic, not a static condition," he said. "Coast intends to exceed the requirements of the law, not just meet them."
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.