Author + information
- Valentin Fuster, MD, PhD∗ ()
- Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- ↵∗Address correspondence to:
Dr. Valentin Fuster, Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, New York 10029.
“Unreasonable haste is the direct road to error.”
In late September, our colleagues Drs. Eric J. Topol and Harlan M. Krumholz issued a call to action in the New York Times for clinical trialists to expeditiously release their raw data for public consumption (2). Subsequently, they published a somewhat similar editorial in The Lancet (3). They use the contemporary Internet era, which has fostered people’s desire to receive information in a more rapid fashion, as an argument to more rapidly communicate findings from clinical trials, suggesting it is time for investigators and journals to “catch up” (3).
Although their recommendations appear to be compelling and innovative, we, as clinicians, always have to consider our first calling to the Hippocratic Oath: To Do No Harm (4). Our responsibility is to protect patients. Thus, we need to consider whether this pathway is truly best for them. Drs. Topol and Krumholz wrote that “lives depend on” the timely, comprehensive pre-publication of clinical data, but in this Editor’s Page, I will explore who will truly benefit from this process.
First, it is important to recognize cardiovascular medicine and research is different than astronomy, mathematics, and computer science—fields that have spearheaded the pre-publication and crowdsourcing peer review process. Why? We are dealing with patients and people’s lives. For example, when a trial is stopped unexpectedly, such as what occurred with SPRINT (Systolic Blood Pressure Intervention Trial), every patient who is enrolled needs to be informed, every participating site needs to follow a pre-specified protocol, and all of the data need to be scrutinized. SPRINT involved approximately 9,400 patients at 102 clinical sites (5). The trial was stopped on August 20, 2015, and it took only 82 days for publication in the NEJM. During that time period, the trialists informed every patient, gathered all the data from the participating sites, adjudicated the data, wrote the publication, submitted the paper for peer review, and had it published online on November 9, 2015. Importantly, how would care have changed if all the raw data had been posted a few weeks earlier? In fact, I will ask you an even more provocative question: How much has care changed now that we know the results? I would venture to suggest that care will change very little in this patient population, even in the few months after the release of these results. We have many precedent-setting examples for the slow translation from the release of clinical trial results to a change in practice (6–8).
Second, more importantly, it should take time for clinicians to alter the course of care for their patients, especially when considering new treatments. Seasoned clinicians need to weigh these results among the breadth of literature on the topic, discuss the results with colleagues, and truly understand how the patient population in a particular study relates to their individual patients. I recently wrote about this specific issue related to the SPRINT trial, and the generalizability of the trial’s findings to the U.S. patient population (9). Again, it takes time to fully assess the findings and determine for which patients a treatment plan is most appropriate.
Third, we challenge the perspective that the peer review process in some way precludes transparency. As I and many others have previously written, the peer review process is not perfect (10). Even one of the cocreators of the Impact Factor, Dr. Eugene Garfield, spoke about the imperfections of peer review at the Impact Factor Fifth International Congress on Peer Review in Biomedical Publication in Chicago in 2005 (11). However, as Garfield pointed out, it seems highly improbable that a new evaluation system wherein individual papers are read and evaluated for quality will be implemented. Thus, this system—however complicated or imperfect—currently exists as the main metric by which to scrutinize the importance of medical publications. One of the goals of the peer review process, and for our role as editors, is to make important data more consumable to the busy practitioner, not to overwhelm them with raw data and charts. They do not have time to read every line of every article in every journal—even within the single cardiovascular specialty.
Thus, I return to my initial question: Who will benefit from the release of such raw data earlier? Researchers who can truly sift through and disseminate what they can utilize for their own research needs. The general public would not benefit because they will not understand all the data and the practicing clinician does not have the time to sift through the raw data. So, I doubt we would be helping our patients with this new form of pre-publication, rather we would be helping our fellow trialists expedite their next project.
- American College of Cardiology Foundation
- ↵Molière. Brainy Quote. Available at: http://www.brainyquote.com/quotes/quotes/m/moliere378426.html. Accessed January 26, 2016.
- Topol E.J.,
- Krumholz H.M.
- Edelstein L.
- Connolly S.J.,
- Eikelboom J.,
- O’Donnell M.,
- Pogue J.,
- Yusuf S.
- Haynes B.,
- Haines A.
- Fuster V.
- Fuster V.
- ↵Garfield E. The agony and the ecstasy—the history and the meaning of the journal Impact Factor. Paper presented at: International Congress on Peer Review and Biomedical Publication; September 16, 2005; Chicago, IL.