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FDA Issues First in Series of Guidances on Patient Experience Measurement

The U.S. Food and Drug Administration (FDA) wants sites and sponsors to feel emboldened when it comes to measuring patient experiences during drug development—and at the same time, FDA wants to see some common sense, too. The agency has just issued a guidance on “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input” that represents the […]

Innovative Clinical Trial Design Survey Report

Industry Warily Approaches Innovative Clinical Trial Design

While clinical trial industry leaders are intrigued by the prospects for leveraging innovative trial design as a vehicle to drive cost savings and improve patient-centricity, more than half of the respondents to a new survey said they do not have a dedicated team or department devoted to it. And they aren’t sure they’ll ever commit […]

Effective Training Programs Can Reverse High Turnover Rates

“There’s nothing more frustrating than being in a role that you know nothing about [and receive] no training for,” says Teri Crumb, MSN, RN, CCRC, a clinical research nurse with Spectrum Health. “You’re not invested in it,” she can attest as a former clinical research coordinator (CRC). Among many downsides, it factors into a very […]

Jim Kremidas, ACRP Executive Director

ACRP to Bolster Entry-Level CRC Workforce Development through Competency-Based Hiring Guidelines

The Association of Clinical Research Professionals (ACRP) today announces a new initiative to create the clinical research industry’s first comprehensive set of competency-based guidelines for hiring clinical research coordinators (CRCs). “Variance is the enemy of quality. The ad hoc manner in which we hire and train CRCs is failing to improve quality in clinical research […]

Opinion: Approaches to Set Up Principal Investigators for Success

Clinical Researcher—June 2018 (Volume 32, Issue 6) PEER REVIEWED Molly Downhour, MHA, BSN, NEA-BC, OCN, CCRC [DOI: 10.14524/CR-18-0002]   Show of hands—how many people believe that principal investigators (PIs) are not currently set up for success? Odds are that not many hands would go up with confidence after that question. As the perception of this […]