Innovation in Clinical Trials

Two AKTN trials to be the first to use ANZDATA’s new real-time data entry

ANZDATA, the Australia & New Zealand Dialysis and Transplant Registry, recently implemented an exciting new program to their 40 year history and it is making new types of renal clinical trials possible.

Real-time web data entry – as the name suggests – enables patient data from renal units across Australia and New Zealand to be collected and displayed in real-time. This is compared to the previous method where data was collected from units via paper forms and only accessible via annual reports.

This new feature launched in December 2016 and was funded by BEAT-CKD (Better Evidence and Translation in Chronic Kidney Disease) via an 2016 NHMRC Program Grant.

It is set to revolutionise clinical trials, by incorporating clinical trial data collection into existing ANZDATA infrastructure, thus allowing the integration of clinical research into standard clinical practice.

The combination of ANZDATA with research has led to the development of “Randomised Registry Trials” (RRTs); an important innovation for the kidney care community. These RRTs should transition relatively seamlessly into existing renal department activities.

Trial data will be sourced from standard data already collected by renal departments for ANZDATA, with some additional trial specific data being collected for study participants. Web-based randomisation systems can also be incorporated into ANZDATA. This fusion of data capture and randomisation into ANZDATA will save time on training, data entry and analysis in addition to reducing costs.

The first studies to be embedded into the ANZDATA’s real-time data entry system are BEST-Fluids and RESOLVE – two new Australasian Kidney Trials Network (AKTN) trials.

The BEST-Fluids trial explores whether the use of the low-chloride intravenous fluid, Plasma-Lyte® 148, reduces delayed graft function and improves graft recovery after kidney transplant compared with the usual standard of care, normal saline.

Patients will be randomised using the Flexetrials randomisation system; both randomisation and data entry will occur via ANZDATA.

The RESOLVE trial is an international collaboration led by The George Institute for Global Health with the Australian arm led by the AKTN. It is a cluster-randomised trial investigating whether low sodium dialysate levels reduce major cardiovascular events in haemodialysis patients and will also collect data via ANZDATA.

These two trials are the first to use ANZDATA real-time capabilities and are excellent examples of the possibilities that this feature presents.

Both are important studies that will provide significant information about kidney disease and improve outcomes and wellbeing for those living with chronic kidney disease.

Importantly, these studies integrate clinical practice with clinical research, and cost much less than traditional clinical trial designs.

For more information, please contact:

Peta-Anne Paul-Brent | Clinical Research Associate, AKTN
E: p.kerr@uq.edu.au
P: 07 3443 7017

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