European Medicines Agency

European Medicines Agency Releases First-in-Human Trial Guidelines

The European Medicines Agency (EMA) just unveiled a guidance for first-in-human clinical trials designed to help stakeholders identify and address risks for trial participants. “Participants in these trials, often healthy volunteers, face an element of risk as the ability of researchers to predict the effects of a new medicine on people is limited before it […]

FDA Logo

FDA Gives Industry Green Light on IRB Waivers for Minimal Risk Studies

A new guidance from the U.S. Food and Drug Administration (FDA) assures sponsors, investigators, and institutional review boards (IRBs) the agency “does not intend” to object to an IRB waiving informed consent requirements for certain minimal risk clinical investigations. To remove this obstacle, however, the IRB must be in the position to demonstrate: The clinical […]

Mark Vermette, Principal Consultant, Halloran Consulting Group Inc.

Clinical Trial Sites Using Metrics as Competitive Tool

Shrinking patient populations and the demand for more trials assessing drugs for such conditions as orphan diseases or chronic pain are making metrics more and more important as a competitive tool, says Mark Vermette, principal consultant at Halloran Consulting Group Inc. “In 25 years, I’ve never seen things moving as fast as I have in […]

Daniel Eisenman, PhD, RBP, SM (NRCM), CBSP, Director of Biosafety Services, Schulman IRB

Rise in Gene Therapy Research Offers Risks, Opportunities

As exciting new approaches to gene therapy enter the research mainstream, some of these advancements may lead to revolutionary treatments of disease, according to Daniel Eisenman, PhD, RBP, SM (NRCM), CBSP, director of biosafety services at Schulman IRB. “The field is no longer considered science fiction, as countries in North America, Europe, and Asia have […]

Robert Jeanfreau, MD, CPI, Owner/Medical Director, MedPharmics, LLC

Physician Advocates New Way to Report Adverse Events

It’s time for clinical researchers to work with the U.S. Food and Drug Administration (FDA) to address the bias inherent in the current definitions used to inform adverse event (AE) reporting, argues Robert Jeanfreau, MD, CPI, owner/medical director at MedPharmics, LLC. “At the outset, the term ‘adverse event’ in and of itself bespeaks a certain […]