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A novel method to interpret early phase trials shows how the narrowing of the coronary sinus concordantly improves symptoms, functional status and quality of life in refractory angina
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  • Published on:
    • Inigo Lozano, Interventional Cardiology Hospital Cabuenes, Gijon, Spain
    • Other Contributors:
      • Jose Miguel, Interventional Cardiology
      • Juan Rondan, Interventional Cardiology
      • Eduardo Segovia, Interventional Cardiology

    We have read with great interest the article written by Jolicoer et al. (1) about the concordant domain analysis, a new method to interpret early phase trials and we applaud their initiative which expands the horizons in the current context of progressive diffuculties to ran studies.
    Randomized controlled trials (RCT) and meta-analysis constitute the highest level of evidence and the chances to succeed are high when there is a strong financial support to launch projects as Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) with 27,564 patients, which in addition to demonstrate the hypothesis of the study, it ensures the external validity and the study of subgroups.
    However, recently we are witnessing a progressively more tortuous environment to launch adequately powered RCTs due to economic restrictions, lower margin to demonstrate cost-effectivity of the new treatments and more strict legal requirements and as the authors quote, only 1 in 10 investigational agents tested in phase III trials reaches the market. Some authors have already raisen concerns about the future of research and the protagonism of new methods as adaptive studies(2) or approaches to emulate RCT (3) are foreseen in the near future.
    In our opinion, the combination of pilot randomized studies with new iniciatives as the described by Jolicoer may be a promising pathway when the conditions to launch large RCTs are not possible and in fa...

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    Conflict of Interest:
    Dr. Lozano belongs to an Educational Board of Medtronic and during 2020 reveived fees of lectures from Abbott, Braun and Amgen