Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health

Research output: Contribution to journalJournal articleResearchpeer-review

  • James D Neaton
  • Abdel Babiker
  • Mark Bohnhorst
  • Janet Darbyshire
  • Eileen Denning
  • Arnie Frishman
  • Jesper Grarup
  • Gregg Larson
  • Lundgren, Jens
A number of reports have highlighted problems of conducting publicly funded trials in Europe as a consequence of the European Union (EU) Clinical Trials Directive. The impact of the EU Directive on multi-national trials, which include sites in Europe that are funded by the US National Institutes of Health (NIH) have not been described.
Original languageEnglish
JournalClinical Trials
Volume7
Issue number6
Pages (from-to)705-18
Number of pages14
ISSN1740-7745
DOIs
Publication statusPublished - 1 Dec 2010

    Research areas

  • Anti-HIV Agents, Clinical Protocols, Clinical Trials as Topic, Drug and Narcotic Control, Europe, European Union, Government Regulation, Guideline Adherence, Guidelines as Topic, HIV Infections, Humans, Internationality, Multicenter Studies as Topic, National Institutes of Health (U.S.), United States

ID: 34171932