Author + information
- Christopher O'Connor, MD, FACC, Editor-in-Chief, JACC: Heart Failure∗ ()
- ↵∗Address for correspondence:
Dr. Christopher O'Connor, Editor-in-Chief, JACC: Heart Failure, 3655 Nobel Drive, Suite 630, San Diego, California 92112
1. An innovative question that is being answered through an experimental protocol for the diagnosis, or treatment of patients with heart failure. The importance of the question is a key feature, and a large or high impact study is of great interest.
2. Novel design characteristics that may afford important information for future clinical trialists. This may include novel inclusion/exclusion criteria, endpoints, or analysis plans.
3. An adequate time period between the publication of the design paper and the publication of the primary results of the trial. In many cases, the primary results papers include supplemental materials inclusive of the design. The purpose of the “long runway” in the publication of a design paper is to continue to encourage enthusiasm for the science behind the proposed intervention, to encourage continued enrollment and enthusiasm for the concept, and to encourage complementary or confirmatory studies in the same field with similar design characteristics that can be used for future meta-analysis, minimizing heterogeneity.
4. A commitment by the investigators to provide the pre-specified statistical analytical plan (SAP) for the trial as supplemental material.
5. A commitment by the investigators to submit primary or secondary analyses of the final results to the Journal.
6. A design paper that encompasses a thorough review of the topic is of great interest. In this manner, the investigators may help readers understand the significance, relevance, and clinical utility of the study.
In this issue of JACC: Heart Failure, the CUPID (Calcium Up-regulation by Percutaneous Administration of Gene therapy In Cardiac Disease) investigators (1) met all criteria for a design paper, and thus represents the first design paper published in the Journal. As design papers have no results, one could suggest that they have limited value. We would argue differently that a design paper, as mentioned previously, can afford many advantages by stimulating complementary and confirmatory designs of clinical trials in similar therapeutic areas that could be used for meta-analysis; to minimize heterogeneity; to enhance the awareness for enrollment of an ongoing clinical trial; to pre-specify the design, such that changes in the design at the time of results publication cannot be overstated; and to augment the information that is provided in clinicaltrials.gov. This will help magnify the trials with the highest-quality design that are in existence, and reduce the cluttering of the medical literature with design papers of investigations that are being submitted only for the purpose of publication and academic advancement. Let's continue to promote the publication of the highest quality and advocate for the design of design papers.
- American College of Cardiology Foundation
- Greenberg B.,
- Yaroshinsky A.,
- Zsebo K.M.,
- et al.