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

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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.

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Conflict of interest

Mihai Gheorghiade: Consultant for Abbott Laboratories, Astellas, AstraZeneca, Bayer HealthCare AG, CorThera, Cytokinetics, DebioPharm S.A., Errekappa Terapeutici, GlaxoSmithKline, Ikaria, Johnson & Johnson, Medtronic, Merck, Novartis Pharma AG, Otsuka Pharmaceuticals, Palatin Technologies, Pericor Therapeutics, Protein Design Laboratories, Sanofi-Aventis, Sigma Tau, Solvay Pharmaceuticals, Takeda Pharmaceutical and Trevena Therapeutics. Stefan D Anker: Consultant for Vifor International, Amgen, Bayer, Bosch GmbH, PsiOxus Therapeutics, Professional Dietetics, Novartis. Research support from Vifor International, PsiOxus Therapeutics. John G F Cleland: Received an honorarium from Bayer for an advisory board. Gregg C Fonarow: Consultant to Medtronic, Novartis, Gambro and Ortho-McNeill. Marco Metra: Received honoraria from Bayer, Corthera, Novartis, and Servier for speeches or participation in advisory boards/steering committees. Frank Misselwitz and Eva Mühlhofer: Employed by Bayer Healthcare. Hani N Sabbah: Research Grants and Consultant to Bayer Healthcare. Naoki Sato: Consultant to Chugai Pharmaceutical Company and honoraria from Daiichi-Sankyo, Otsuka, Philips Respironics, Astellas, Ono, Eisai, Chugai, Mitsubishi-Tanabe, Sanofi-Aventis, and Novartis pharmaceuticals. John R Teerlink: Research Grants from Corthera, Novartis, Cytokinetics, Amgen, NIH. Consultant to Amgen, Anexon, Cardio3 Bioscience, CardioMEMS, Cytokinetics, Gambro, Johnson and Johnson, Merck, NovaCardia, Novartis, Scios, Sorbent Therapeutics, St. Jude Medical, Teva, Theravance, Trevena. Faiez Zannad: Reports receiving consultant honoraria from Servier, Pfizer, Novartis, ResMed, Takeda, and Boston Scientific, and that his institution receives research grants from Roche Diagnostics and BG Medicine. Dirk J van Veldhuisen: Board Membership fees from Amgen, BG Medicine, Pfizer, Sorbent and Vifor. Javed Butler: Consultant to Cardiomems, Trevena, Bayer Healthcare, Takeda, Gambro, Ono Pharma, and Amgen; Events Committee for WorldHeart, Corthera, Abbott Vascular, Celladon, Research Support, NIH, GE Healthcare and Medtronic. All other authors have no conflicts of interest to declare.

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Authors and Affiliations

  1. Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, 645 N. Michigan Avenue, Suite 1006, Chicago, 60611, IL, USA

    Mihai Gheorghiade & Stephen J. Greene

  2. Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

    Muthiah Vaduganathan

  3. Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC, USA

    Robert J. Mentz

  4. University of North Carolina School of Medicine, Chapel Hill, NC, USA

    Kirkwood F. Adams Jr.

  5. Centre for Clinical and Basic Research, IRCCS San Raffaele, Rome, Italy

    Stefan D. Anker

  6. Division of Cardiology, University of Western Ontario, London, ON, Canada

    Malcolm Arnold

  7. Novartis Pharma AG, Basel, Switzerland

    Fabio Baschiera

  8. Castle Hill Hospital, Hull York Medical School, Kingston-Upon-Hull, UK

    John G. F. Cleland

  9. Momentum-Research, Inc., Durham, NC, USA

    Gadi Cotter

  10. Division of Cardiology, University of California, Los Angeles, CA, USA

    Gregg C. Fonarow

  11. Quintiles, Cardiovascular and Metabolic Therapeutic Delivery Unit, Durham, NC, USA

    Christopher Giordano

  12. Division of Cardiology, University of Brescia, Brescia, Italy

    Marco Metra & Savina Nodari

  13. Bayer Healthcare Pharmaceuticals, Berlin, Germany

    Frank Misselwitz

  14. Bayer Vital GmbH, Leverkusen, Germany

    Eva Mühlhofer

  15. Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, USA

    W. Frank Peacock

  16. Division of Cardiology, Medical University of Graz, Graz, Austria

    Burkert M. Pieske

  17. Department of Medicine, Henry Ford Hospital, Detroit, MI, USA

    Hani N. Sabbah

  18. Department of Internal Medicine and Cardiology, Nippon Medical School Musashi-Kosugi Hospital, Kanagawa, Japan

    Naoki Sato

  19. National Heart Lung and Blood Institute, Bethesda, MD, USA

    Monica R. Shah

  20. Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Norman L. Stockbridge

  21. Section of Cardiology, San Francisco Veterans Affairs Medical Center, University of California, San Francisco, CA, USA

    John R. Teerlink

  22. Department of Cardiology, University of Groningen, Groningen, The Netherlands

    Dirk J. van Veldhuisen

  23. Novartis Pharmaceutical Corporation, East Hanover, NJ, USA

    Andrew Zalewski

  24. Inserm CIC 9501 and U961, Université de Lorraine, CHU Cardiology, Nancy, France

    Faiez Zannad

  25. Division of Cardiology, Emory University School of Medicine, Atlanta, GA, USA

    Javed Butler

Authors
  1. Mihai Gheorghiade
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  2. Muthiah Vaduganathan
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  3. Stephen J. Greene
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  4. Robert J. Mentz
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  5. Kirkwood F. Adams Jr.
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  6. Stefan D. Anker
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  7. Malcolm Arnold
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  8. Fabio Baschiera
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  9. John G. F. Cleland
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  10. Gadi Cotter
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  11. Gregg C. Fonarow
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  12. Christopher Giordano
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  13. Marco Metra
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  14. Frank Misselwitz
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  15. Eva Mühlhofer
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  16. Savina Nodari
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  17. W. Frank Peacock
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  18. Burkert M. Pieske
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  19. Hani N. Sabbah
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  20. Naoki Sato
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  21. Monica R. Shah
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  22. Norman L. Stockbridge
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  23. John R. Teerlink
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  24. Dirk J. van Veldhuisen
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  25. Andrew Zalewski
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  26. Faiez Zannad
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  27. Javed Butler
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Corresponding author

Correspondence to Mihai Gheorghiade.

Appendices

Appendix 1

See Table 4.

Table 4 Selecting Investigators and Sites for global clinical trials in patients hospitalized for heart failure (HHF): current state and future direction—Program Agenda
Full size table

Appendix 2

 

Group

Members

 

Non-industry

Physicians

Adams Jr., Kirkwood

Mentz, Robert

 

Anker, Stefan

Metra, Marco

 

Arnold, Malcom

Nodari, Savina

 

Butler, Javed

O’Connor, Chris

 

Cotter, Gadi

Peacock, Frank

 

Cotter-Davison, Beth A.

Pitt, Bertram

 

Daum, Douglas

Ruschitka, Frank

 

Domanski, Michael

Sabbah, Hani

 

Gheorghiade, Mihai

Sato, Naoki

 

Greenberg, Barry

Teerlink, John

 

Holzmeister, Johannes

Van Veldhuisen, Dirk

 

Liu, Peter

Yancy, Clyde

 

Massie, Barry

Zannad, Faiez

NIH

Gordon, David

Mascette, Alice

 

Desvigne-Nickens, Patrice

Shah, Monica

Industry

Abbot POC

Morgan, Jayne

Sethuraman, Barathi

Amgen

Kim, Jae

 

Bayer

Cook Bruns, Nancy

Misselwitz, Frank

 

Delvers, Thomas

Muehlhofer, Eva

 

Ewald, Silke

Oechsner, Sven

 

Nowak, Christina

Roessig, Lothar

Cardiorentis

Schnee, Elmar

 

Cytokinetics

Woolf, Andrew

 

J&J

Barret, Terrance

Gengo, Peter

 

Porter, Brandon

Peters, Gary

 

Burton, Paul

Radziszewski, Waldemar

Medtronic

Hill, Michael R. S.

 

Merck

Cody, Robert

Koglin, Joerg

Novartis

Zalewski, Andrew

 

Ono Pharma

Kang, Sok

Ross, Douglas

 

Kiyoshi, Hidekazu

Soumaoro, Ibrahima

Otsuka

Krasa, Holly

Zimmer, Chris

Quintiles

Mahaux, Veronique

 

SigmaTau

Giuseppi, Bianchi

 

Sticares

Yun, Chris

 

Takeda

Knapp, Beth Anne

Kupfer, Stuart

Trevena

Swiggard, Pamela

 

Meeting coordinators

Kozeli, Devi

Mallery, Michelle

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Gheorghiade, M., Vaduganathan, M., Greene, S.J. et al. Site selection in global clinical trials in patients hospitalized for heart failure: perceived problems and potential solutions. Heart Fail Rev 19, 135–152 (2014). https://doi.org/10.1007/s10741-012-9361-8

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