Archives     Advertise     Editorial Calendar      Advertiser Index     Subscribe     Contact Us    


Study Shows Registry Data Could Support Clinical Trials


 

Data captured in NCDR registries is similar in quality, depth and granularity when compared to data captured through clinical trials, according to research in JACC: Cardiovascular Interventions that compared data from the DAPT Study to NCDR CathPCI Registry data. This is good news for streamlining data collection and supports recent efforts to standardize data elements and definitions used in clinical trials and registries.

"We found an overall high level of similarity in data between these two sources. This suggests that registries may also be suitable to support baseline data collection for many clinical studies," said senior study author Robert W. Yeh, MD, MSc, director of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology at the Beth Israel Deaconess Medical Center and associate professor of Medicine at Harvard Medical School. "Being able to leverage existing registries to provide data for clinical trials has the potential to greatly enhance the efficiency and lower the costs of conducting these important studies."

The researchers linked a group of Dual Antiplatelet Therapy (DAPT) Study patients to the NCDR CathPCI Registry and compared data elements for the same patients. All patients receiving percutaneous coronary intervention (PCI) with drug-eluting stents randomized in the DAPT Study who could be linked to the CathPCI Registry were included. Baseline patient and procedural characteristics were compared using data collected by two methods: reports submitted by DAPT Study investigators and site-reported data submitted to the CathPCI Registry.

Out of 8,864 DAPT Study patients, 5,743 (65%) were successfully matched to data in the CathPCI Registry. There was strong agreement with many data elements, including demographics and procedural characteristics. For some prior history and risk factors, there was more modest agreement and agreement was poor for clinical presentation. According to the researchers, most notably, angina was more likely to be classified as unstable in the CathPCI Registry versus the DAPT Study.

The results suggest that CathPCI Registry data could be used to support future clinical trials, decreasing the burden of data collection on sites participating in both trials and the registry. However, variables that could be considered more subjective, such as clinical presentation, would likely need to be defined more precisely. Future trials leveraging the CathPCI Registry would also need to ensure that the key data elements are suitable to answer key trial questions.

"Whether these findings generalize to other types of data in the CathPCI Registry or other clinical registries is unknown and remains a rich area for future inquiry," Yeh said. "Overall, however, the data are promising in pointing to an important mechanism to make clinical trials more feasible and less costly, helping to overcome one of the most significant barriers to clinical research."

The primary limitations of the study were the inability to link all patients. In addition, how these results would have fared for other clinical trials is unknown.

 
Share:

Related Articles:


Recent Articles

Grant Creates Center for Maternal, Pediatric Precision Therapeutics

Vanderbilt University Medical Center has been awarded a five-year, $6 million grant from the National Institutes of Health (NIH) to serve as a center of excellence for Maternal and Pediatric Precision in Therapeutics (MPRINT).

Read More

Change in Respiratory Care Strategies for Preterm Infants Improves Health Outcomes

A decade's worth of data shows that neonatologists are shifting the type of respiratory support they utilize for preterm infants, a move that could lead to improved health outcomes.

Read More

The Fear of the Unknown: Anxiety and the Upcoming School Year

Nurture the Next Discusses Ways to Help Children Cope as they Return to School

Read More

Older Age, Chronic Co-Morbidities Associated with More Severe COVID Disease in Children

Over the course of the pandemic, researchers nationwide noticed differences in COVID-19 disease between children and adults.

Read More

Envision Healthcare Shares Resources to Support Clinician Mental Health

National Medical Group Uses Systematic Professional Well-Being Approach to Support Clinicians' Wellness

Read More

Monroe Carell Jr. Children's Hospital at Vanderbilt Debuts New State-of-the-Art Maternal Fetal Clinic

Expectant parents never imagine they'll face tough decisions about treatments or surgeries for their unborn babies following a potentially devastating fetal diagnosis. But for thousands of families each year, this is a harsh reality.

Read More

Answering the Call to Train More Physicians

Local healthcare leaders address the growing need for doctors nationwide

Read More

Back to School with COVID

After enjoying a taste of 'return to normal' earlier this year, the Delta variant has changed the trajectory of the pandemic and plunged communities into crisis again.

Read More

Addressing Kids' Health in Tennessee

New plans designed to impact social determinants of health among Tennessee's kids

Read More

ACS Updates Children's Surgery Verification Program Standards

Updated standards from ACS Children's Surgery Verification Program emphasize new patient care expectations for participating hospitals.

Read More

Email Print
 
 

 

 


Tags:
None
Powered by Bondware
News Publishing Software

The browser you are using is outdated!

You may not be getting all you can out of your browsing experience
and may be open to security risks!

Consider upgrading to the latest version of your browser or choose on below: