Trainee‐led collaboratives, clinical trials and new opportunities in the COVID‐19 era

Over the last decade, UK‐based trainee‐led research collaboratives have delivered large‐scale clinical studies which have informed and impacted modern surgical practice. The success of these collaboratives has inspired the adoption of a similar model in Australia and New Zealand. In 2017, the Section of Academic Surgery within the Royal Australasian College of Surgeons recognized the value of trainee‐led collaboratives and supported the development within Royal Australasian College of Surgeons of Clinical Trials Network Australia and New Zealand (CTANZ). The role of CTANZ is to facilitate and nurture the development and growth of trainee‐led collaboratives and to equip trainees to formulate and instigate research that will contribute significantly to our profession. CTANZ has fostered the development of more than 15 national, binational or regional trainee‐led collaboratives, all supported by experienced mentors. These collaboratives span the geographic breadth of Australia and New Zealand, and are underpinned by the diversity of surgical specialities.

CTANZ provides a platform of leadership to empower trainee collaboratives to enable trainees to pivot from poorly constructed methodologies and low‐quality studies, such as retrospective case note series, towards more robust studies that will impact surgical practice. The focus has been on quality research training aligned with Good Clinical Practice and participation in large prospective multicentre studies, including randomized controlled trials. In developing these collaboratives, CTANZ has been supported by the established UK‐based networks that sit under the umbrella of Clinical Trials Network UK within the Royal College of Surgeons of England. Australian and New Zealand collaboratives have benefited immensely from their ability to participate in large‐scale international projects led from the UK, with expertise and experience readily shared by our UK colleagues.

In March 2020, however, the world changed, and momentum and planning in the clinical trials space was disrupted by coronavirus disease 2019 (COVID‐19). The need for social distancing, disruption to international and domestic travel, lockdowns across various regions and repurposing of some healthcare services to prioritize COVID‐19 demand have all adversely impacted surgical training, trainee engagement with research and the ability of CTANZ collaboratives to continue business as usual. In addition, institutional research offices have re‐prioritized how they do business, with COVID‐19‐related research fast tracked, but other projects put on hold. The question now asked is ‘does this research increase the risk of COVID‐19 infection for either participants or researchers?’ and this filter is being applied to existing and new projects. Consequently, problems have inevitably arisen within some areas of clinical research, but with it new opportunities have arisen for research undertaken by trainee collaboratives in Australia and New Zealand.

CTANZ collaboratives across the different regions are now operating in a different clinical and research environment to that experienced in much of the rest of the world. Our experience has been different to the UK, where hospitals have been severely impacted by COVID‐19, and all UK‐based collaborative surgical trials have been suspended indefinitely. The situation is not the same in Australia and New Zealand and research has been able to continue, albeit with the caveat in place that research protocols should not increase the risk of infection by COVID‐19. This advantages our collaboratives and offers them an opportunity to provide leadership to the advance of clinical research in 2020.

An example is SUNRRISE, a randomized trial developed in Birmingham, UK. ¹ This trial compares the impact of a single‐use negative pressure versus standard wound dressing on wound infection following emergency laparotomy. The original design aimed to recruit 630 patients within the UK. Australian funding obtained from the Medical Research Future Fund in late 2019 is supporting the recruitment of a further 210 patients to improve the statistical power of the trial from 80% to 90% and support a health economic evaluation specific to the Australasian environment. The UK recruitment commenced in 2019 but ceased from late March, with approximately 400 patients recruited before COVID‐19 impacted UK health services. Australian recruitment commenced in late January 2020 and has been excellent with nearly 150 patients recruited in the first 5 months at four hospitals, with further sites opening. It is expected that the Australian target will be met in the next few months, and this will ensure the initial target of 630 patients is met, thereby guaranteeing the success of the overall SUNRRISE trial.

Flexibility of the CTANZ platform has also enabled rapid responses to the changing environment, with participation in international trainee collaboratives evaluating the impact of COVID‐19 on surgical outcomes. An example is CovidSurg, an international prospective audit of outcomes in patients infected with COVID‐19 who undergo surgical interventions. ² This study builds on the platform of GlobalSurg, ³ an international collaborative that recently reported data from 10 745 patients in 58 countries. ⁴ Another study is COVER run by the vascular trainees in Australia, New Zealand and the UK to evaluate outcomes of vascular surgery patients in the COVID‐19 crisis. This study entails a tiered response looking at service provision, the changing presentation and outcome of patients and impact of the coronavirus disease itself on vascular thrombosis. CovidSurg Cancer represents another study which will determine the impact of COVID‐19 on cancer outcomes. ²

Permission to contribute data to these studies has been granted in record time across many hospitals in Australia and New Zealand, with research offices working hard to support trainees and their mentors to progress these studies. A positive consequence of COVID‐19 seems to be a unified response to the crisis which is enabling a fresh approach to approvals for clinical research, and also surgeons seeking to improve clinical outcomes in this changing environment. It is hoped that this approach to research approval will continue beyond the pandemic era! It is also hoped that all College training boards will consider collaborative research projects favourably and count contributions towards research training requirements, as well as selection into training programmes. A move in this direction is the research point scheme for general surgery training from 2022 which emphasizes collaborative research.

The message is clear; CTANZ networks and the trainees who work together as one have been able to step up and respond to the crisis despite the restrictions that COVID‐19 has imposed. Trainees have demonstrated leadership and enthusiasm to contribute to practice‐changing research and prospective audit. We hope the surgical community recognizes this and leverages these achievements to continue to build the CTANZ platform so that it can be utilized for trainees and surgeons across Australia and New Zealand undertaking research and audit in the future.