Robert Romanchuk, Schulman IRB Vice Chair

Device Clinical Trials Present Unique Challenges

A clinical trial focused on a device is markedly different than one focused on a drug—a distinction that sometimes gets lost, warns Rob Romanchuk, BHS, CIP, CCRC, CCRCP, vice chair of Schulman IRB. “They’re twin sons of different mothers,” Romanchuk says. “They’re different in nature.” The U.S. Food and Drug Administration emphasizes that the intended […]

Professional Pathways Boost Staff Retention in Clinical Research Settings

Nearly three years in, Duke University’s School of Medicine has enjoyed the positive impact of an innovative program to professionalize its clinical research workforce. For starters, it’s become an important retention tool in a competitive job market. “It’s so important to establish a professional pathway for people,” says Denise Snyder, MS, RD, LDN, associate dean for […]

Sharon Shriver, Director of Programs, Public Responsibility in Medicine and Research (PRIM&R)

Are Your Studies Ethically Sound?

For Sharon Shriver, it’s a simple equation. “Poorly designed research is inherently unethical,” says the director of programs for Public Responsibility in Medicine and Research (PRIM&R). Part of the remedy, Shriver says, is to incorporate ethical considerations into study design. “It’s not a focus for institutional review boards [IRBs], but it should be,” she notes. […]

Jeff Kingsley headshot

Sites, Sponsors Need to Come Together to Fix ‘Broken’ Clinical Trial Business Model

The “broken” clinical trial business model discourages sites from investing in new tools and training to improve performance, says site expert Jeff Kingsley, DO, MBA, CPI, FACRP. Sponsor “budgets are not [currently] incentivized for quality control,” notes Kingsley, chief executive officer of IACT Health and Chair of the 2017 Association Board of Trustees for the Association […]

Jill Chapman, BHSc, CCRA, Senior Manager, Training & Development, ACRP

Lax Adverse Event Collection Can Hit Trials Hard at Closing Time

Clinical research coordinators (CRCs) who perfunctorily “check the box” during adverse event (AE) collections can cause serious problems at the other end of the clinical trial, says Jill Chapman, BHSc, CCRA, senior manager for training and development with the Association of Clinical Research Professionals (ACRP). While any threat to subject safety is the paramount concern, listless […]