PIs Struggle With ‘One and Done’ Phenomenon

Principal investigators (PIs) who dip one toe into conducting clinical trials with dreams of easy, new money streams are often in for a rude awakening. Studies have demonstrated a large—and growing—percentage of PIs join the so-called “One and Done” club, whose members are PIs who get involved in a trial, find the experience overwhelming, and […]

FDA Unveils Real-World Evidence Program Framework

Just in time for the holidays, the U.S. Food and Drug Administration (FDA) has giftwrapped and delivered the framework it plans to use to implement its Real-World Evidence (RWE) Program. FDA defines RWE as the “clinical evidence about the usage and potential benefits or risks of a medical produce derived from analysis of” real-world data […]

FDA Shows No Letup with New Biomarker Guidance

Traditionally, the workplace pace slows as the holiday spirit overtakes us in December. Days are a little less productive. Employees take vacations. It’s a time usually reserved for office parties and long lunches. Tell that to the U.S. Food and Drug Administration (FDA). Yesterday (December 12), the agency released another clinical trial–related guidance—this one providing […]

Happy Holidays! The ACRP Holiday Mix has Gone Country!

In honor of our trip to the ‘Music City’ for ACRP 2019, April 12-15, 2019, we’re getting you in the holiday spirit “Nashville style.” Happy Holidays from all of us at ACRP, and we’ll see y’all in Nashville! Trouble with the Player? Click Here to Stream in Your Browser What a Year It’s Been! 2018 […]

What Do Sites Really Want from Sponsors and CROs? ACRP/Avoca Survey Explains

The Association of Clinical Research Professionals (ACRP) and The Avoca Group surveyed nearly 300 clinical trial study site staff earlier this year to determine the most important factors for advancing quality in studies from their perspectives. What follows is a conversation about the results with Jim Kremidas of ACRP and Dennis Salotti of The Avoca […]