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We Have Ruined Late-Breaking Clinical Trials in Cardiology

— In this Revolution and Revelation, Milton Packer explains why a cornerstone of annual meetings has gone from sizzler to snoozer

Last Updated November 14, 2017
Ƶ MedicalToday

For many years, the most vibrant sessions at a cardiology meeting were those devoted to Late-Breaking Clinical Trials.

These sessions were the focus of attention for many good reasons. These were important trials whose results had been long awaited. Their findings had the potential to change medical practice quickly. The results were kept secret, so that the audience was actually surprised when a slide showing the primary data went up on the screen. In many instances, you might hear gasps or applause. These were moments of revelation and revolution.

I remember presenting the results of the The trial had been completed only a few weeks earlier, and the results were known to only five people. There had been no press releases or news conferences before the presentation. The trial had the potential to transform the treatment of heart failure (if successful) or to cause the stock price of the sponsor to plummet (if unsuccessful).

The audience gasped when the slide of the main findings appeared on a 50-foot wall. Failure of the trial to achieve its primary endpoint led the stock price of Bristol-Myers Squibb to fall nearly 40% in the following hour! If you attended a cardiology meeting for drama, you were not disappointed.

Late-Breaking Clinical Trials had an overwhelming effect on cardiology meetings. They were so popular that program committees typically devoted 3 or 4 sessions to these presentations. Thousands of delegates swarmed the hall. The Trials sessions energized the meeting, overshadowing other worthy talks. But the medical press loved it, and the lay press carried the stories on their front pages.

Those days have passed.

The number of important large-scale trials in cardiology has declined dramatically, and program committees struggle to fill their Clinical Trials sessions with worthy material.

Presenters do not take unfiltered questions from the audience; instead, commentary is provided by pre-selected speakers. The results are no longer secret; often, they have been previously presented or were announced at a conference several days earlier. Many investigators publish the main results simultaneously in a prestigious journal. The authors now spend their time giving press interviews, but these are drowned out by interviews with medical pundits who opine about the results -- often without having ever seen the data. Reactions on websites now overwhelm the primary findings.

Cardiologists will know how people felt about a trial more often than what the investigators reported.

How bad has it gotten?

There has not been an original presentation of data at the Clinical Trials session at the Heart Failure Society of America for nearly a decade.

Last year, program organizers at the American Heart Association meeting reached out to me personally to see if I had anything new to present. At the European Society of Cardiology meeting this year, it is rumored that the Hot Line session includes data from the findings of a study of experimental myocardial infarction in mice.

Here is the problem. Not only have the number of important trials dwindled, but we have orchestrated events so as to eliminate all of the energy that these sessions used to generate in the past. There is still an audience when clinical trials are presented at a major meeting, but it is small and quiet, and most shrug their shoulders at the conclusion of a session.

Many cardiologists never attend the session at all. They remain at home, watching a video on their computer, disconnected from any potential for energy in the audience.

They are not missing very much. The passion in the room died out a long time ago.

Disclosures

Packer has recently consulted for Amgen, Boehringer Ingelhim, Cardiorentis and Sanofi. He was one of the two co-principal investigators for the PARADIGM-HF trial (sacubitril/valsartan) and currently chairs the Executive Committee for the EMPEROR trial program (empagliflozin).