FDA Headquarters

FDA Challenges Industry to Improve Patient-Centric Clinical Trials

Talking to patients in a cursory way simply to check off that box is not what true patient-centric clinical trials are all about, according to John Whyte, Director of Professional Affairs and Stakeholder Engagement at the Food and Drug Administration (FDA). The agency wants to see evidence that the trial designers know exactly what they […]

Wide Gaps in Patient Informed Consent Comprehension Impact Recruitment, Tax CRCs

There’s work to be done, according to a massive review of 30 years of journal article data and 103 studies that found just 52.1 percent to 75.8 percent of study volunteers understood different components of informed consent. “That's not the result we've found in our own application, but that did surprise me,” says Nadine Nemunaitis, […]

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 8: Fewer […]