ICH E6 (R2) Puts More Pressure on Quality Risk Management Plans

“Any risk management plan is going to be important, but even more so now because we have the ICH E6 revision [from the International Council for Harmonization] that explicitly calls for quality management” in the conduct of clinical trials, notes Deborah Rosenbaum, a clinical research consultant and trainer with Sarrison Clinical Research, llc. The ICH […]

Ernest Prentice, PhD, Associate Vice Chancellor for Academic Affairs, University of Nebraska Medical Center

Solid Definitions of ‘Noncompliance’ Can Minimize Clinical Trial Risks

Breaches in research integrity can happen anywhere, anytime, and at any point in the clinical trial process, warns Ernest Prentice, PhD, associate vice chancellor for academic affairs at the University of Nebraska Medical Center. The public must see that clinical research is ethical and in full compliance with regulations, Prentice says. “Conducting clinical trials is […]

FDA's Drug Trial Snapshots Report

FDA Report Shows Growth in Clinical Trial Participation Among Women, African Americans

A new report from the U.S. Food and Drug Administration (FDA) suggests there has been some improvement in terms of advancing diversity in clinical trial research, though recent reports suggest more work remains to be done. In 2016, FDA’s Center for Drug Evaluation and Research (CDER) approved 22 novel drugs, either as new molecular entities […]

How to Make Clinical Research Mentor Programs Work

Forget the cliché of the “wise, older” employee who takes a newbie under his or her wing. “I’ve had mentors younger than me and it’s worked out great,” says Elizabeth Weeks-Rowe, LVN, CCRA, who works out of San Diego, Calif., as a principal clinical research associate in study start-up for a major contract research organization […]