Clinical Trials Advisor

Sponsors should have an easier time submitting consistent, standardized data to show they are conducting non-IND foreign clinical studies under good clinical practices (GCP), thanks to a new FDA guidance on a 2008 rule change.

The clinical trials process took center stage recently as Center for Drug Evaluation and Research Director Janet Woodcock proposed speeding drug approvals by allowing smaller trials and discussed upcoming guidance on accelerated approval endpoints.

Centers for Medicare & Medicaid Services (CMS) advisers are encouraged by the promise of anti-vascular endothelial growth factor (anti-VEGF) agents for treating diabetic macular edema (DME), but want to see comparative studies of drugs for that condition before recommending coverage.

The FDA’s Center for Drug Evaluation and Research is planning to release guidance on the use of multiple trial endpoints, one of several trial guidances slated for publication this year.

Sites typically predict about 12 percent profit when negotiating budgets with sponsors and CROs, yet what they realize when the trial is over is closer to 2 percent, a site expert says.

While most drugmakers are good about keeping postmarket clinical trials on schedule, they don’t always file their required annual status reports on time.

An FDA warning that Merck could face fines for being months late on two postmarket study deadlines appears to be the first time the FDA has invoked new enforcement authority for postmarking requirements granted under the 2007 FDA Amendments Act (FDAAA) and may signal a new agency trend, a legal experts says.

Drugmakers struggling to determine whether they must register and submit trial results to ClinicalTrials.gov have an ally in attorney Scott Cunningham, a member of Covington & Burling’s FDA practice who has significant experience in new product development and clinical trials.

A key FDA advisory committee unanimously recommended that modeling and simulation methods be considered for use in all pediatric drug development programs, but its enthusiasm was not extended to models touted by the agency’s Office of Clinical Pharmacology (OCP).