Community recruitment into very large-scale clinical trials through general practice in Australia.

Conference:

SAPC ASM 2019 - Exeter

Talk Code:

P1.47

Presenter:

Mark Nelson

Co-authors:

MR Nelson (1, 2), JE Lockery (2), CM Reid (2, 3), RL Woods (2), AM Tonkin (2), S Zoungas (2), JJ McNeil (2).

Author institutions:

1. Menzies Institute for Medical Research, University of Tasmania, Hobart TAS, Australia, 2. School of Public Health and Preventive Medicine, Monash University, Melbourne VIC, Australia, 3. School of Public Health, Curtin University, Perth WA, Australia.

Problem

Ask hospital and institutionally based researchers about conducting clinical research in general practice and they will tell you it is doomed to failure given the inability of general practitioners (GPs) to deliver the participants they desire. The problem lays not in primary care but the approach taken due to the lack of familiarity with the primary care sector.

Approach

Over the last 24 years we have developed research recruitment, retention and conduct methods that have allowed us to conduct the largest clinical trials ever in the country (e.g. NEJM 2003;348(7):583-589; (2) NEJM 2018;379(16)1500-1508) in Australian general practice right across the continent. The strategy can be summarised as: (a) Having a research question relevant to GPs and their patients; (b) Giving appropriate status and some financial compensation to GPs and practices; (c) Having at least one experienced GP clinician as a principal investigator; (d) Minimising GP and practice workload by providing research staff in the practice for recruitment and data collection: (e) Limiting GP commitment to clinical decision making and; (f) Flexibility to accommodate the variety found in general practice.

Findings

Using these methods we have conducted and completed trials, as well as continuing to conduct ongoing studies, with around 2500 GP co-investigators in each, approximately 10% of the entire Australian workforce. Studies as exemplars include ANBP2 (N = 6,083), ASPREE (N = 19,114 with 16,703 in Australia) and STAREE (N = 4,711 to 1-3-19 of planned 18,000).

Consequences

Large-scale clinical outcome trials have been successfully conducted in Australian primary care for nearly a quarter of a century. Lessons can be learned, and ideas exchanged between the UK and Australia given the differing yet in some ways similar healthcare systems and populations they serve.

Submitted by:

Mark Nelson

Funding acknowledgement:

Merck Sharp and Dohme, National Institutes for Aging (US), National Cancer Institute (US), National Health and Medical Research Council of Australia, Monash University, National Heart Foundation of Australia.