Download PDFPDF
Original research
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
Compose Response

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Author Information
First or given name, e.g. 'Peter'.
Your last, or family, name, e.g. 'MacMoody'.
Your email address, e.g.
Your role and/or occupation, e.g. 'Orthopedic Surgeon'.
Your organization or institution (if applicable), e.g. 'Royal Free Hospital'.
Statement of Competing Interests


  • A rapid response is a moderated but not peer reviewed online response to a published article in a BMJ journal; it will not receive a DOI and will not be indexed unless it is also republished as a Letter, Correspondence or as other content. Find out more about rapid responses.
  • We intend to post all responses which are approved by the Editor, within 14 days (BMJ Journals) or 24 hours (The BMJ), however timeframes cannot be guaranteed. Responses must comply with our requirements and should contribute substantially to the topic, but it is at our absolute discretion whether we publish a response, and we reserve the right to edit or remove responses before and after publication and also republish some or all in other BMJ publications, including third party local editions in other countries and languages
  • Our requirements are stated in our rapid response terms and conditions and must be read. These include ensuring that: i) you do not include any illustrative content including tables and graphs, ii) you do not include any information that includes specifics about any patients,iii) you do not include any original data, unless it has already been published in a peer reviewed journal and you have included a reference, iv) your response is lawful, not defamatory, original and accurate, v) you declare any competing interests, vi) you understand that your name and other personal details set out in our rapid response terms and conditions will be published with any responses we publish and vii) you understand that once a response is published, we may continue to publish your response and/or edit or remove it in the future.
  • By submitting this rapid response you are agreeing to our terms and conditions for rapid responses and understand that your personal data will be processed in accordance with those terms and our privacy notice.
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Vertical Tabs

Other responses

Jump to comment:

  • 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...

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