Poster Presentation Asia Pacific Stroke Conference 2024

Beyond the protocol: Navigating ethics and governance in the multisite QASC Australasia Trial (#342)

Simeon Dale 1 2 , Oyebola Fasugba 1 2 , Kelly Coughlan 1 2 , Sawsan Saheb 1 2 , Elizabeth McInnes 1 2 , Dominique A Cadilhac 3 , N Wah Cheung 4 , Kelvin Hill 5 , Kirsty Page 6 , Estela Sanjuan Menendez 7 , Emily Neal 8 , Vivien Pollnow 6 , Julia Slark 9 , Anna Ranta 10 11 , Eileen Gilder 9 , Christopher Levi 12 13 , Jeremy M Grimshaw 14 15 , Sandy Middleton 1 2
  1. Nursing Research Institute, St Vincent’s Health Network Sydney, St Vincent’s Hospital Melbourne and Australian Catholic University, Sydney, New South Wales, Australia
  2. School of Nursing, Midwifery and Paramedicine, Australian Catholic University, Sydney, New South Wales, Australia
  3. Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia
  4. Centre for Diabetes and Endocrinology Research, Westmead Hospital and University of Sydney, Sydney, New South Wales, Australia
  5. Stroke Foundation, Sydney, New South Wales, Australia
  6. St Vincent’s Health Network Sydney, Sydney, New South Wales, Australia
  7. Vall d’Hebron Hospital Universitari , Barcelona, Catalonia, Spain
  8. Prince of Wales Hospital, Randwick, New South Wales, Australia
  9. School of Nursing, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand
  10. Department of Medicine, University of Otago, Wellington, New Zealand
  11. Department of Neurology, Wellington Hospital, Wellington, New Zealand
  12. John Hunter Hospital, Newcastle, New South Wales, Australia
  13. Department of Medicine, University of Newcastle, Newcastle, New South Wales, Australia
  14. Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
  15. Methodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

Background: Multicentre studies require ethics and governance approvals from individual sites with the potential for duplication and costly delays.
Aim: To describe the ethics and governance approval processes for a multicentre international stroke randomised controlled trial (QASC Australasia Trial). Findings were compared to our previous Australian multicentre T3 Trial.
Method: Prospective, descriptive analysis (November 2021 - April 2024) for Australian sites.
Results: We required lead ethics approval from NSW (n=1), ethics approvals from Western Australia (n=1) and Northern Territory (n=2), with n=52 individual site governance applications. Lead ethics took 4.3 weeks (median), requiring one revision; all three ethics approvals took 1.6 weeks (median) (range: 0.6-4.3 weeks). Median time for 45 governance approvals was 13.1 weeks (range: 0.9-54.3 weeks) excluding 6 sites awaiting approval (median 51.9 weeks, range: 12-72.6 weeks to-date). Median time for Clinical Trials Research Agreement execution (n=45 sites) was 7.4 weeks (range: 0.9-44.4 weeks). The 2012-2014 T3 Trial processes were longer: lead ethics took 10 weeks (median); all five ethics approvals took 6 weeks (median) (range: 3-10 weeks); 21 governance approvals took 16 weeks (median) (range: 7-28 weeks). According to the recommended 8.6-week timeframe1, ethics review time was met for all applications but exceeded in 68.9% (n=31/45) of governance applications.
Conclusion: While there are notable improvements in obtaining ethics approval, the governance process for multicentre studies continues to be time consuming, contributing to delays in translation of research into practice. It is hoped the National One Stop Shop initiative will eradicate delays and better utilise scarce research resources.

  1. Clinical Trials Action Group. 2011. Clinically competitive: Boosting the business of clinical trials in Australia. Available from: https://www.ihacpa.gov.au/sites/default/files/2022-08/clinically_competitive_boosting_the_business_of_clinical_trials_in_australia._clinical_trials_action_group_report.pdf