Should We Rethink the Embargo and Late-Breaking Clinical Trials Policies for Cardiology Meetings?
It's been said that embargos are remembered more in the breach than in compliance. One such embargo breach recently made headline news at the ACC.13 in San Francisco last month when an eagerly-awaited late-breaking clinical trial (LBCT)—the PREVAIL study—was pulled at the last minute by the ACC leadership after the sponsor, Boston Scientific, issued a press release 3 hours before the scheduled presentation, a clear violation of the embargo agreement. The story was big for two reasons: it reignited the debate surrounding embargos, leading some critics to question whether the embargo process should be more flexible or be done away with altogether; and it also shone a spotlight on the role of LBCTs in inflating the importance of research findings and sustaining the embargo process.
Proponents of embargos argue two fundamental reasons in their support: First, they level the playing field between news organizations, giving reporters an equal break on the news and reducing the risk of being scooped by competitors. Second, they promote accurate, orderly journalism by giving the news media the opportunity to vet the facts in a timely manner to develop high-quality and informed discussion of new research.
Critics of embargos are quick to point out there is sparse evidence showing that they increase the quality and accuracy of science news. In fact, some accuse it of dampening journalistic initiative by encouraging shoddy 'churnalism' where prepackaged contents of press releases—often overhyped spin prepared by trial sponsors and investigators—are regurgitated, instead of critical and thoughtful interpretations of research findings. Others view embargos as a public relations tactic that serves to advance the profit-driven agenda of the scientific societies and journal publishers by giving them high visibility and media exposure. The embargo system, they argue, acts as a barrier to free and rapid exchange of information to advance scientific discourse, and as such it does not serve the public interest. Indeed, some scholarly societies such as the American Geophysical Union and others see no need for an embargo. As a result, preprint servers, that bypass the embargo process, are rapidly mushrooming in disciplines as varied as astronomy, chemistry, computer science, mathematics, and physics.
Late-Breaking a Little Too Soon
Closely joined at the hip with the embargo process, and fueling it to some extent, is the phenomenon of LBCT presentations. Often viewed as the brass ring of society meetings, the LBCT sessions provide the latest high-profile breakthroughs in clinical research, enabling notable exposure and recognition for important and potentially practice-changing studies. The ACCF/AHA/ESC guidelines for LBCT presentations stipulate that the submitted LBCT abstracts are "expected to contain at a minimum the study design; information on the characteristics of the patients enrolled is desirable as well, and if available, the major trial results should be summarized and will be maintained in a confidential fashion."
Some LBCT presentations are accompanied by simultaneous online publication in top-tier medical journals such as The New England Journal of Medicine, JAMA, and Lancet. These journals provide expedited, rigorous peer review and editorial evaluation to coordinate publication with their presentation at society meetings in compliance with the societies' embargo policy.
However, many LBCTs do not undergo rigorous peer review and their merit is often judged on the basis of only an abstract without careful consideration of trial design, protocol, and statistical methods. This was the case with the PREVAIL trial at ACC.13, and also with other notable LBCTs in the recent past (such as PROTECT-AF and EVEREST-II, to name a few). Hailed initially as major breakthroughs, the results of these trials struggled through the peer review process and ultimately failed to pass the scrutiny of regulatory agencies.
This then begs the question: why the rush to present LBCTs that aren't thoroughly peer-reviewed? Have LBCTs become more theater than substance where reality cannot be separated from rhetoric, and where promotional agenda and commercial interests trump the rigor of the scientific process? And how does the embargo serve to enhance the quality and credibility of such unvetted research other than cloaking it in mystery and enhancing its newsworthiness?
"Information Wants to Be Free"
In its aftermath, the PREVAIL trial incident, the latest in a series of high-profile embargo breaches to hit recent cardiology meetings, should trigger some introspection among the societies and journal publishers to revisit their LBCT and embargo policies.
For example, only research that withstands rigorous peer-review scrutiny (and ideally accompanied by a simultaneous publication) should receive the LBCT's imprimatur. This is not to say that the peer-review process will necessarily ensure the information presented or published is always correct or reliable. The traditional peer-review system, flawed as it is, is still the best thing we have in terms of filtering and evaluating scientific research. Their value is in enabling LBCT sessions to highlight the most meritorious, not the most high-profile or newsworthy, research to the public.
Ideally, the embargo process should be replaced by a system that champions full and open disclosure of research results as soon as they are ready for public consumption, and after undergoing rigorous peer review. Once a publication has been accepted by a medical journal, scientists and their institutions should be free to disseminate the results, and journalists should be able to report on it if they deem it important and newsworthy—free from the perceived tyranny of the embargo.
Finally, the scientific community should take its time to digest the data and weigh in regarding the quality and importance of research findings in post-publication, web-based, open-review process. As said eloquently by the Silicon Valley futurist Stewart Brand nearly 3 decades ago, "Information wants to be free." It is time the medical societies, journal publishers, news media, and journalists heed this wisdom.
Sanjay Kaul, MD, is director of the Vascular Physiology and Thrombosis Research Laboratory at the Burns and Allen Research Institute at Cedars-Sinai Medical Center in Los Angeles. Dr. Kaul also directs the Cardiology Fellowship Training Program and the Cardiology Consult Service.
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