"This may be a very efficient and cost-effective way of doing randomized clinical trials," said Deepak Bhatt, MD, FACC.

Prospective registry-based randomized clinical trials, such as the TASTE Trial presented during the ESC Congress 2013, represent a new opportunity for clinical research, particularly when it comes to addressing one clinically important hypothesis with reliable hard endpoints, according to Stefan James, MD, of Uppsala University, Sweden.

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.

Additional Resources ESC Congress 2013 Meeting Coverage ACC National Cardiovascular Data Registries TASTE RRCT Presentation Slides ACC International Center

However, he notes that the traditional clinical trials are also expensive, take a long time to plan and complete, are often sponsored by industry, and are often not performed in broad representative patient populations. In contrast, national clinical registries have representative patient populations and networks for collaboration and could be used to complement randomized clinial trials in terms of assessing therapeutic options available and/or used in routine clinical care.

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."

Keywords: Registries, Sweden, Coronary Angiography, Thrombosis, Lost to Follow-Up, Angioplasty, Taste

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