GCP

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The FDA issued a warning letter to a Texas clinical researcher, claiming he deviated from his own investigational plan by enrolling ineligible trial subjects. Read More

The FDA’s rules for clinical investigators cover a lot of ground, from how to avoid financial conflicts of interest, to delegating investigator authority to other members of the trial team, to hiring—and sometimes firing—investigators under your charge. The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but even those documents can’t answer every question you may have about the people who actually conduct the trial. Read More

The FDA ruled the use of mitochondrial replacement technology in clinical research is illegal. Read More

The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but those documents can’t answer every question you may have. Fortunately, the agency offers another resource — the staff of its Office of Good Clinical Practices. Every day, OGCP fields questions from investigators, sponsors, IRBs and other interested parties. Read More

How much training do clinical investigators and clinical study staff need to stay up to date on good clinical practices, particularly to ensure compliance for multiregional clinical trials? In a recent study, the Clinical Trials Transformation Initiative evaluated the content, frequency, format and enrollment evidence of GCP training and provided recommendations to improve the efficiency of GCP training. Jonathan Seltzer, the director of clinical research at the Lankenau Heart Institute and a co-author of the study, “Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency,” talks with CTA about the findings. Read More

A lack of diversity in clinical studies can have crucial health implications in minority populations, as medicines are launched with little understanding of genetic interactions, researchers and regulators warn. Read More

Roughly a fifth of cancer clinical trials fail to recruit enough participants, creating a “major barrier to progress” for developing new therapies, according to a paper published in the Journal of the National Cancer Institute. Read More

Tweaking even one part of a clinical trial’s protocol — which happens more than half of the time in global trials — takes a toll on research, according to an analysis from the Tufts Center for the Study of Drug Development. Read More