TASTE: Is There a Role For Registry-Based Randomized Clinical Trials in Clinical Research?
In a presentation during the ESC Congress' Sept. 4 Hot Line Session, James said there is still a large need for traditional randomized trials, particularly for evaluating strategies, devices and pharmacological therapies. "Correctly designed randomized clinical trials are still the gold standard," he said.
James highlighted the TASTE Trial in which a total of 7,244 STEMI patients undergoing PCI and enrolled in the Swedish Coronary Angiography and Angioplasty Registry were assigned to manual thrombus aspiration followed by PCI or to PCI only. Because the study was conducted via a national registry it was easy to track whether the patient provided oral consent and whether inclusion and no exclusion criteria were met, he said. In addition, no patients were lost to follow-up of the primary outcome.
Despite the many benefits of registry-based trials, James did note there are several challenges, including data completeness, data validity, monitoring, adjudication, staff workload, variable definitions and trial design limitations, that should be taken into consideration when determining what type of trial should be used. As such, registry-based trials should be used as a complement to classical clinical trials, not as a substitute, he said.
A commentary in the New England Journal of Medicine echoes the challenges raised by James and cautions that there are still fundamental questions that need to be answered before jumping on the registry-based trial bandwagon. "Today we can no longer afford to undertake randomized effectiveness trials that cost tens or hundreds of millions of dollars," the authors write. "But today we also have registries and other powerful digital platforms. Today it may be possible to conduct mega-trials with what we have: bigger data and smaller budgets. Yet we must also recognize and acknowledge the daunting challenges that diverse groups of researchers and stakeholders must overcome to get there."
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