FDAnews Device Daily Bulletin

Good Clinical Practices Start With Communication at Sites

March 7, 2011
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Clinical investigators should make sure they maintain contact with sponsors, IRBs and regulators throughout clinical trials to keep up good clinical practices. After the initial rush of activity to approve and set up a clinical trial, the different parties involved often fall out of contact, sometimes until something goes wrong, Lisa Berdan, assistant director of cardiovascular megatrials at the Duke Clinical Research Institute, told CTA. “There’s enormous pressure on sites at the beginning of the trial, but the real work is in the middle,” Berdan said. “And if you wait to the end to bring up issues, it’s too late.”
Clinical Trials Advisor