Clinical Trials Weakened by Poor Diversity Outreach

Clinical trials underserve the public health and, in some cases, limit the value of the data amassed from a pool of subjects, say a number of experts in the field and officials at the U.S. Food and Drug Administration (FDA). Too often “minorities are underserved and it may impede their health,” suggests Lea H. Becker, […]

FDA, Industry Must Partner to Increase Minority Representation in Clinical Trials

The Food and Drug Administration’s (FDA) initiatives to promote clinical trial diversity are likely to help increase the participation of underserved minority groups, say FDA officials and industry practitioners. “We're actively involved in communication strategies to ensure that information about FDA-regulated products is getting to minority communities, including those with limited English proficiency,” says Jonca […]

John Neal, CEO of PCRS Network

Prediction: Fewer Study Visits Will be Conducted at Clinical Research Sites

This is the eighth installment in the series (Change is in the Air) on changes coming to the clinical research enterprise that John Neal, CEO of PCRS Network, began in April 2016, with the prediction that “major changes are coming that will be disruptive, displacing many people currently working in the industry.”

Prediction […]

Nikki Couturier

Don’t Let Sponsors Dictate Billing Payment Schedule and Terms

Site managers do themselves a disservice if they don’t press sponsors to consider monthly payments as opposed to the industry standard quarterly schedule, says Nikki Couturier, BSRT, CCRC, a budget and contract specialist with IACT Health. “Sponsors are showing more willingness to work with sites on payment frequency,” Couturier says. In the past, payment schedule […]

FDA Inspections Shift Focus to CAPAs, Could Come at Any Time

While matters related to how informed consent is obtained at study sites remain at or near the top of most U.S. Food and Drug Administration (FDA) inspectors’ checklists, they’ve also shown an increasing interest in corrective and preventive action (CAPA) programs, says Dr. DeAnn Cary, director of research with Sharp Healthcare in San Diego, Calif. […]