A/Prof Rathika Krishnasamy1,2, Ms Laura Robison2, Dr Martin Howell3, Professor Kirsten Howard3, Ms Donna Reidlinger2, Dr Aparna Shenoy2, Dr Alistair Mallard2, Dr Elaine Pascoe2, A/Prof Yeoungjee Cho2,4, A/Prof Andrea Viecelli2,4, A/Prof Matthew Roberts5, Professor Nigel Toussaint6, Professor Sunil Badve7, Dr Chen Au Peh8, Dr Ashley Irish9, Professor David W Johnson2,4, Professor Carmel M Hawley2,4
1Sunshine Coast University Hospital, Birtinya, , 2The University of Queensland, Brisbane, , 3The University of Sydney, Sydney, , 4Princess Alexandra Hospital, Brisbane, , 5Eastern Health Clinical School, Monash University, Melbourne, , 6Royal Melbourne Hospital, Melbourne, , 7The George Institute, Sydney, , 8Royal Adelaide Hospital, Adelaide, , 9Fiona Stanley Hospital, Perth ,
Aim: Identify the challenges and equity-related issues in kidney trials.
Background: Major challenges in conducting clinical trials include slow recruitment, inclusion of low-risk participants that limit study power and generalisability of outcomes, suboptimal treatment adherence, and limited dissemination of the findings. These challenges are likely to be exacerbated for vulnerable subgroups, particularly the socially disadvantaged, ethnic minorities and the elderly.
Methods: A retrospective review of seven completed investigator-initiated trials coordinated by the Australasian Kidney Trials Network (AKTN) from 2005 to 2019 was undertaken. The review was performed by 2 independent assessors who collated data addressing key areas of trial conduct and performance as they relate to equity, recruitment, and ability to achieve trial objectives.
Results: All trials successfully secured government funding in 14.2 ± 8.7 months following submission of a proposal to AKTN. Ethics approval occurred in 1.5 ± 0.6 months, however subsequent first site activation took a median of 9.2 [interquartile range (IQR) 2-24] months, primarily due to contracts and investigational product procurement. Median time for trials to close-out recruitment was 38 (IQR 33-64) months and recruitment target was achieved in two trials. Telehealth or phone visits were used in 29% of trials. Most (94%) participating sites had dedicated research staff, however only 8.0% sites were from regional and remote areas. Neither trial protocols nor dissemination methods addressed the needs of First Nations peoples or culturally and linguistically diverse groups.
Conclusions: This review identified challenges in conducting investigator-initiated trials and provided process improvement strategies for trial operations. Improving trial efficiencies, reducing disparity and increasing consumer partnerships will be key priorities for AKTN trials.
Biography:
A/Prof Krishnasamy is an Academic Clinical Nephrologist, based at the Sunshine Coast University Hospital and Associate Professor for the Faculty of Medicine at the University of Queensland. She is a Clinical Trialist at Australasian Kidney Trials Network (AKTN) and a recipient of The Queensland Advancing Clinical Research Fellowship. She holds numerous national appointments including Chair of the Caring of Australians and New Zealanders with Kidney Impairment (CARI) Guidelines Steering Committee, Council Member for Australian and New Zealand Society of Nephrology (ANZSN), Haemodialysis Working Group member for the AKTN and Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry. A/Prof Krishnasamy is also the Australian co-lead investigator for PHOSPHATE (Pragmatic randomised trial of High Or Standard PHosphAte Targets in End-stage kidney disease) and Australian Lead Investigator for Better Evidence and Translation for Calciphylaxis (BEAT-Calci) Study.