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Reassessing Phase II Heart Failure Clinical Trials: Consensus Recommendations.

Javed Butler1, Carine E Hamo2, James E Udelson2

  • 1From the Department of Medicine, Stony Brook University, NY (J.B., C.E.H.); Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, MA (J.E.U.); Division of Cardiology, Inova Heart & Vascular Institute, Falls Church, VA (C.O'C.); Department of Medicine, Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, MI (H.N.S.); Division of Cardiology, University of Brescia and Civil Hospital, Italy (M.M.); Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, IL (S.J.S., C.Y.); Section on Cardiovascular Medicine, Wake Forest School of Medicine, Winston-Salem, NC (D.W.K.); Division of Cardiology, University of California San Francisco (J.R.T.); Merck & Co., Kenilworth, NJ (H.S.B., J.K.); Gilead Sciences, Foster City, CA (G.B., J.H., C.S.); Amgen Inc., Thousand Oaks, CA (C.D., M.K.); Bristol-Myers Squibb, Princeton, NJ (M.M.D., M.D., R.J.F., P.M., S.M., C.R.); Bayer, Wuppertal, Germany (W.D., M.v.d.L.); Department of Cardiology, HELIOS Clinic Wuppertal, University Hospital Witten/Herdecke, Germany (W.D.); AstraZeneca, Gaithersburg, MD (R.F.-D., J.H., L.-M.G.); AstraZeneca, Gothenburg, Sweden (R.F.-D., J.H., L.-M.G.); Relypsa Inc., Redwood City, CA (D.G., M.M.); Vifor Pharma, Opfikon, Switzerland (U.-M.G.); Department of Cardiology, Nippon Medical School Musashi-Kosugi Hospital, Kawasaki, Japan (S.I.); Novartis Pharmaceuticals Inc., East Hanover, NJ (P.K.-M., V.S.); Sanford Burnham Prebys Medical Discovery Institute, La Jolla, CA (C.J.L.); Bayer Pharma AG, Wuppertal, Germany (L.R.); Cardiology Division, Columbia University Medical Center, New York, NY (C.R.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (A.S.); Moderna Therapeutics, Cambridge, MA (B.T.); Division of Cardiovascular and Renal Products, United States Food and Drug Administration, Silver Spring, MD (N.S.); Center for Cardiovascular Innovation, Feinberg School of Medicine, Northwestern University, Chicago, IL (M.G.). javed.butler@stonybrook.edu.

Circulation. Heart Failure
|March 31, 2017
PubMed

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Summary

Developing new heart failure therapeutics requires improving phase II clinical trials. A Food and Drug Administration meeting highlighted shortcomings and recommended strategies for better trial design and execution to advance patient care.

Area of Science:

  • Cardiovascular Research
  • Clinical Trial Design
  • Translational Science

Background:

  • Suboptimal patient outcomes in heart failure necessitate novel therapeutic development.
  • Effective translation of basic science discoveries into clinical application is crucial.
  • Phase II clinical trials are pivotal for advancing potential heart failure treatments.

Framework:

  • Critically examining existing phase II trials in heart failure reveals significant shortcomings.
  • Identifying challenges in concept, design, execution, and interpretation of phase II trials.
  • Facilitating dialogue among clinicians, researchers, industry, and regulators to address these issues.

Implementation:

  • A Food and Drug Administration-convened meeting on October 17, 2016, focused on improving phase II trials.
Keywords:
United States Food and Drug Administrationclinical trialheart failuremortalitysafety

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  • Discussions involved key stakeholders including clinicians, researchers, industry representatives, and regulators.
  • The meeting aimed to foster collaboration and identify actionable recommendations.

    • Implications:

    • Addressing shortcomings in phase II trials is essential for successful drug development.
    • Improved trial design and execution can accelerate the delivery of effective heart failure therapies.
    • Key recommendations are provided to guide future directions in heart failure research and clinical trials.