Registry-based randomized clinical trials

The Swedish quality registers are a gold mine for research. In the field of medical devices, registry-based observational studies that result in extensive product development have long been the norm.

Now, increasingly, registry-based randomized clinical trials (RRCT) are being conducted. The first was performed using Swedeheart, a register covering care of patients with acute cardiac infarction, planned catheter-borne coronary vessel surgery, and valve replacement in cardiac surgery. UCR is the registry center for Swedeheart and was responsible for developing the complete technical solution essential for the success of the RRCT concept. The technical solution is continuously being developed to meet new requirements and to enable larger and more complex trials.

In principle, all Swedish hospitals report their data to Swedeheart which facilitates conducting randomized clinical studies within the framework for registration. The computer randomly selects who will, and who will not, receive a given treatment. This makes the studies unique because they not only recruit a large number of patients but also reflect the clinical reality.

The first registry-based randomized clinical trial was called TASTE and compared two treatment options – thrombectomy with PCI-treated cardiac infarction with elevated ST, or PCI alone. When the results were presented in September 2013 they generated tremendous international interest. Thirty days after surgery, it was found that there was no difference in survival between the patient groups. Follow-up a year after the intervention confirmed this result.

This new knowledge has resulted in changes in clinical practice in Sweden. Prior to TASTE, thrombectomy was performed in about half of all cases of ST-elevated infarction treated with PCI; in 2014, this number had fallen to about 15%.

RRCT is suitable for many fields within healthcare and TASTE has been followed by several other ongoing, registry-based randomized clinical studies. The studies are of high quality and yet still significantly cheaper than the normal randomized clinical trials. Moreover, they permit evaluation of established treatment options that have no commercial interest for the pharmaceutical industry.

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