Surviving the nasty surprise of investigator fraud in the US
This article was originally published in SRA
Fraudulent behaviour by clinical investigators can sink a trial and, if only caught post-launch, savage market confidence in a new drug. With a number of high-profile cases of research malpractice emerging this year, Jonathan Hare asks the US Food and Drug Administration what contract research organisations can do to protect themselves.
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Asia has been rapidly developing in importance as a destination for global clinical trials in recent years. The recent launch of a major new report by the European Medicines Agency (EMA) shows that the region is still growing strongly as a site for patient recruitment. Still, there is, as always, wide variability by country and the region has not remained static, with at least one country that was previously a cornerstone of growth seeing recruitment decline in the face of ongoing quality issues, while another formerly isolated nation is rapidly becoming a key destination for global trials.
The early-phase US-based clinical contract research organisation Cetero Research has appointed James Dixon to be its senior vice president of quality and compliance. Mr Dixon joins the Cary, North Carolina-based firm from Medimmune, where he held the position of vice president of GxP Quality Compliance. Mr Dixon's 25-year long career in the pharmaceutical industry has seen him hold executive positions at a number of CROs, including Parexel International, ClinTrials Research, and Covance.
The Council for Scientific and Industrial Research in the African nation of Ghana has set up its first institutional review board to have oversight over clinical trials performed in the country. An institutional animal care and use committee has also been established to protect the welfare of animals used in research1,2.