Data captured in NCDR records are similar in quality, depth, and granularity compared to data captured through clinical trials, according to research in JACC: cardiovascular interventions which compared the data from the DAPT study with the data from the NCDR CathPCI registry. This is good news for streamlining data collection and supports recent efforts to standardize data elements and definitions used in clinical trials and records.
“We found a high level of overall similarity in the data between these two sources. This suggests that records may also be appropriate to support reference data collection for many clinical studies, ”said study lead author Robert W. Yeh, MD, MSc, director of the Richard A. and Susan F. Smith Cardiology Research Center at Beth Israel Deaconess Medical Center and associate professor of medicine at Harvard Medical School “. Being able to leverage existing records to provide data for clinical trials has the potential to significantly increase efficiency and reduce the costs of conducting these important studies. ”
The researchers related a group of patients with antiplatelet therapy (DAPT) study to the NCDR CathPCI registry and compared the data elements of the same patients. All patients receiving percutaneous coronary intervention (PCI) with randomized drug choice stents in the DAPT study that could be linked to the CathPCI registry. Basic patient characteristics and procedures were compared using data collected by two methods: reports submitted by researchers from the DAPT study and data presented at the site in the CathPCI registry.
Of the 8,864 patients in the DAPT study, 5,743 (65%) were successfully associated with CathPCI registry data. There was strong agreement with many data elements, including demographic data and procedural characteristics. For a previous story and risk factors, there was a more modest agreement and the agreement was poor for clinical presentation. According to the researchers, in particular, angina was more likely to be classified as unstable in the CathPCI registry compared to the DAPT study.
The results suggest that CathPCI registry data could be used to support future clinical trials, decreasing the burden of data collection to the sites participating in both tests and registration. However, variables that could be considered more subjective, such as clinical presentation, would probably need to be defined more precisely. Future trials taking advantage of the CathPCI record should also ensure that key elements of the data are adequate to answer key test questions.
“It is not known whether these findings are generalized to other types of CathPCI registry data or other clinical records and remains a rich area for future research,” Yeh said. “Overall, though data they are promising in pointing out an important mechanism for clinical making essays more feasible and less costly, helping to overcome one of the most significant barriers to clinical research. “
The main limitations of the study were the inability to relate all patients. Also, how would these results have been for others clinical trials is unknown.
JACC: cardiovascular interventions, DOI: 10.1016 / j.jcin.2021.03.065
American College of Cardiology
Citation: Study Shows Registry Data Could Support Clinical Trials (2021, June 21) Retrieved June 22, 2021 at https://medicalxpress.com/news/2021-06-registry-clinical-trials .html
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