Former FDA Commissioner Robert M. Califf, MD

Former FDA Commissioner Calls for Increased Clinical Trial Education

Even as the clinical research enterprise is poised for “transformational progress,” swifter advancements in clinical trials are hampered by wariness over technology, miscommunication between industry and regulators, and a lack of education, former U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf, MD, said during a Clinical Trials Transformation Initiative (CTTI) webinar on March […]

Clinical Trial Operations (GCPs)

Core Competencies Could Strengthen Clinical Workforce

Having a set of core competencies will be “incredibly helpful” in addressing the current clinical research associate (CRA) shortage, says Bonnie Miller, RN, MS, a clinical research consultant and president of the Association of Clinical Research Professionals (ACRP) Northern California Chapter. “This job requires tangible standardized role competencies,” says Miller, who is also an adjunct […]

Clinical Trials Transformation Initiative 2016 Annual Report

CTTI, ACRP Focus on Improved Informed Consent Standards

The Clinical Trials Transformation Initiative (CTTI) has already helped raise the bar for improving informed consent procedures with a series of strategies and tools to “reorient” the process, according to its just-released annual report. However, there’s more to be done. “While significant advancements have been made, many opportunities remain to improve clinical research,” says […]