Ken Getz

Tufts Analysis: Patient Recruitment Shortcomings Laid at Feet of Poor Provider, Researcher Engagement

Sponsors, contract research organizations, and investigative site personnel aren’t adequately engaging nurses and physicians as partners in the quest to encourage patients to participate in clinical trials, says a new analysis from the Tufts Center for the Study of Drug Development (CSDD). Healthcare providers might be justified in feeling some vindication, says Ken Getz, associate […]

Presidential Seal

Califf to Step Down as Trump Mulls New FDA Commissioner

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, MACC, will end his short-lived tenure with the agency just as Donald Trump places his hand on the Bible and is sworn in as the 45th President of the United States on January 20. Califf’s record has been marked by a number of positive achievements […]

Christina Talley, MS, RAC, CCRP, CCRC, Program Director, Office of Strategic Research Initiatives, Houston Methodist

Realistic Workforce Metrics Key to Successful Trials

Clinical research coordinators and clinical research associates struggling under onerous workloads are likely the victims of ill-conceived trials lacking realistic workload measurements that accurately measure the knowledge and capabilities of those who actually conduct the trials, says Christina Talley, MS, RAC, CCRP, CCRC, a program director with the Office of Strategic Research Initiatives at Houston […]

Shauna Itri, MD, JD, Berger & Montague, PC

Whistleblowers Face Tangled Legal Landscape

While sometimes critical to preserving both the quality and integrity of clinical trials, whistleblowers can face roadblocks—professional and personal—if they file a complaint. Understanding and anticipating those minefields can protect a trial practitioner who is genuinely worried about fraud that may be undermining the safety and efficacy of a trial, says Shauna Itri, MD, JD, […]

eConsent

FDA Guidance Emphasizes Importance of Robust Informed Consent Program

A new U.S. Food and Drug Administration (FDA) guidance hammers home the agency’s aggressive focus on proper informed consent programs that ensure patient safety, help subjects comprehend clinical trial specifics, and demonstrate data integrity. The “Use of Electronic Informed Consent—Questions and Answers” guidance for institutional review boards (IRBs), investigators, and sponsors also reminds industry that […]