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FDA Offers Tips on What Triggers Inspections

Clinical trial sponsors, clinical investigators, and institutional review boards often struggle to understand what most often triggers a U.S. Food and Drug Administration (FDA) inspection—especially one that is unannounced. The prospect of an unannounced FDA inspection can loom over a clinical trial site. While the vast majority of inspections are prescheduled, FDA is more likely […]

Jennifer Goldbarb

Leverage Budgeting as Opportunity to Boost Competitive Edge

Believe it or not, a sponsor who pushes back on a site’s budget requests might be doing the site’s leaders a favor. “In some cases, it can show that the site has hidden inefficiencies that make it charge [above the going rate] for a trial or specific piece of a trial,” says Jennifer Goldfarb, MSN, […]

Susan Warne, Associate Site and Patient Networks Director, QuintilesIMS

Patient-Centered Informed Consent Boosts Compliance, Retention

While moral issues are paramount, a strong patient-centered informed consent process can also improve retention and patient compliance, says long-time industry expert Susan Warne, associate site and patient networks director at QuintilesIMS. However, a patient-centric program must not focus solely on the individual in the trial. Trial practitioners should engage other family members and friends […]

CTTI Releases Recommendations, Tool for Pregnancy Testing in Trials

The Clinical Trials Transformation Initiative (CTTI) just released new recommendations and an online tool to help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans. Among CTTI’s broad recommendations for investigators and sponsors developing a trial protocol: It should clearly state the specific purposes of pregnancy testing in the research study. […]

Dr. David Gerber, Associate Professor of Internal Medicine and Clinical Sciences, Associate Director of Clinical Research, Harold C. Simmons Comprehensive Cancer Center

Rapid Rise in Trial Eligibility Requirements Discouraging New Participants

Increasing trial complexity and a stubborn rise in exclusion criteria are discouraging subject participation—and the trend shows no sign of abatement. For example, there’s been an estimated 60% increase in exclusion criteria in National Cancer Institute–sponsored trials over the past 20 years, according to a new study from researchers at the University of Texas (UT) […]