Site selection in global clinical trials in patients hospitalized for heart failure: Perceived problems and potential solutions

Mihai Gheorghiade*, Muthiah Vaduganathan, Stephen J. Greene, Robert J. Mentz, Kirkwood F. Adams, Stefan D. Anker, Malcolm Arnold, Fabio Baschiera, John G.F. Cleland, Gadi Cotter, Gregg C. Fonarow, Christopher Giordano, Marco Metra, Frank Misselwitz, Eva Mühlhofer, Savina Nodari, W. Frank Peacock, Burkert M. Pieske, Hani N. Sabbah, Naoki SatoMonica R. Shah, Norman L. Stockbridge, John R. Teerlink, Dirk J. Van Veldhuisen, Andrew Zalewski, Faiez Zannad, Javed Butler

*Corresponding author for this work

Research output: Contribution to journalArticle

36 Scopus citations

Abstract

There are over 1 million hospitalizations for heart failure (HF) annually in the United States alone, and a similar number has been reported in Europe. Recent clinical trials investigating novel therapies in patients with hospitalized HF (HHF) have been negative, and the post-discharge event rate remains unacceptably high. The lack of success with HHF trials stem from problems with understanding the study drug, matching the drug to the appropriate HF subgroup, and study execution. Related to the concept of study execution is the importance of including appropriate study sites in HHF trials. Often overlooked issues include consideration of the geographic region and the number of patients enrolled at each study center. Marked differences in baseline patient co-morbidities, serum biomarkers, treatment utilization and outcomes have been demonstrated across geographic regions. Furthermore, patients from sites with low recruitment may have worse outcomes compared to sites with higher enrollment patterns. Consequently, sites with poor trial enrollment may influence key patient end points and likely do not justify the costs of site training and maintenance. Accordingly, there is an unmet need to develop strategies to identify the right study sites that have acceptable patient quantity and quality. Potential approaches include, but are not limited to, establishing a pre-trial registry, developing site performance metrics, identifying a local regionally involved leader and bolstering recruitment incentives. This manuscript summarizes the roundtable discussion hosted by the Food and Drug Administration between members of academia, the National Institutes of Health, industry partners, contract research organizations and academic research organizations on the importance of selecting optimal sites for successful trials in HHF.

Original languageEnglish (US)
Pages (from-to)135-152
Number of pages18
JournalHeart Failure Reviews
Volume19
Issue number2
DOIs
StatePublished - Mar 2014

Keywords

  • Clinical trials
  • FDA
  • Heart failure
  • Site selection

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Gheorghiade, M., Vaduganathan, M., Greene, S. J., Mentz, R. J., Adams, K. F., Anker, S. D., Arnold, M., Baschiera, F., Cleland, J. G. F., Cotter, G., Fonarow, G. C., Giordano, C., Metra, M., Misselwitz, F., Mühlhofer, E., Nodari, S., Frank Peacock, W., Pieske, B. M., Sabbah, H. N., ... Butler, J. (2014). Site selection in global clinical trials in patients hospitalized for heart failure: Perceived problems and potential solutions. Heart Failure Reviews, 19(2), 135-152. https://doi.org/10.1007/s10741-012-9361-8