Clinical Trials Advisor

In a ruling with potentially broad implications, a federal judge has ordered a company conducting a clinical trial of an experimental treatment for genetic mutations to give the drug to a patient deemed ineligible to participate in the study.

Amid calls for an investigation, the All India Institute of Medical Sciences (AIIMS) denies that the deaths of 49 infants were caused by investigational drugs, saying the children already were seriously ill.

Since patient recruitment is the most time-consuming part of a clinical trial, sites and sponsors are trying to accelerate and improve the process, according to a report.

The FDA’s Center for Drug Evaluation and Research (CDER) is seeking sponsors to participate in a one-year pilot project for electronic submission and processing of clinical trial data in XML format.

A hospital IRB that oversees device clinical trials violated regulations and its own written procedures in several areas, including subject protection and informed consent, according to an FDA warning letter.

The FDA has issued an order permanently debarring clinical investigator Anne Kirkman-Campbell from providing services to anyone with an approved or pending drug application.

The integrated summary of effectiveness (ISE) required in NDAs and encouraged in BLAs should include a detailed analysis of study results rather than just a summary of individual trials, according to an FDA draft guidance.

Sponsors of clinical trials for biotechnological products made from cell lines must submit test results for viruses in end-of-production cells or unprocessed bulk and complete validation studies of virus reduction, according to a European Medicines Agency (EMEA) guideline.

A psychiatrist who sponsored or served as an investigator in clinical trials of a significant-risk device failed to ensure that the studies were monitored, enrolled ineligible patients and did not obtain informed consent, an FDA warning letter says.

The IRB of the Hospital Municipal de San Juan, Puerto Rico, wrongly told a principal investigator that a pediatric drug safety trial posed “minimal risk,” according to an FDA warning letter.