Glenn Veit, IRB chairperson at Copernicus Group IRB (CGIRB), a leading independent review board, was among the featured speakers at this month’s “Creating a Global Clinical Trial Platform: Partnering for Synergy” symposium in Durham, N.C..
Veit, a frequent industry speaker, was joined by co-panelists from Duke Medicine, Harvard University and the Duke University Health System IRB to present information on the obstacles faced in conducting multiregional clinical trials. Veit’s presentation specifically addressed the challenges IRBs and other stakeholders in clinical research face regarding safety reporting and the exceedingly high volume of reports received. Veit referenced recent guidance from the U.S. Food & Drug Administration (FDA) aimed at reducing the reporting burden and offered solutions to decreasing over reporting.
The symposium, led by CGIRB in collaboration with the Drug Information Association (DIA) and the Duke Clinical Research Institute (DCRI), focused on creating synergy in the conduct of global clinical trials.
“It’s clear that there are emerging issues in global clinical research that need to be addressed,” Veit said. “Hearing the perspectives of my co-panelists and the thought-provoking questions from attendees illustrated the fact that there is a lot of work that we, as an industry, have to do to become real leaders in improving efficiencies and data quality and ensuring the safety of human clinical trial subjects at home and internationally.”
About Copernicus Group IRB
Experience and innovation in ethical review®
Copernicus Group IRB (cgirb.com), established in July 1996, is a leading U.S. independent institutional review board (“IRB”) dedicated to ensuring the rights and welfare of research study participants. The IRB provides ethical review of research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004, reaccreditation in 2007 and 2011, and ISO 9001:2008 certification in 2010.
About the Drug Information Association (DIA)
The Drug Information Association (diahome.org) is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and wellbeing worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India and Beijing, China.
About Duke Clinical Research Institute (DCRI)
The Duke Clinical Research Institute (dcri.org), the world's largest academic clinical research organization, is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding.