Statistics

An ongoing pandemic response, beyond mass vaccination, will be required of political and health systems throughout 2022

Mark J Hanly · Timothy Churches · Oisin Fitzgerald · Jeffrey J Post · C Raina MacIntyre · Louisa Jorm

A national education program would facilitate achieving the full potential of highly effective curative therapies

Paul J Clark

To the Editor: A significant driver of research waste is the incentive to do research for career progression, rather than for its relevance and patient impact, especially when volume is rewarded over quality.1 We previously found that most specialty training colleges mandate that trainees conduct research, often without requiring research training and appropriate supervision. The focus tends to be on completing projects and leading research, rather than on learning fundamental research principles.2 We also wanted to understand how these incentives are built into the selection process for specialty training programs before the training even begins. In 2020, we reviewed the research‐related selection criteria on publicly available documents and websites for the training programs of 63 Australian and New Zealand specialty colleges and their subspecialty divisions. These were categorised as mandatory or encouraged; for those that used a points‐based system to grade the application, we extracted the proportion that research was worth to the overall application. While no colleges stated that research was a mandatory requirement to apply to a training program, 46 encouraged research on the prospective trainee’s application and 12 used a points‐based system to quantify their research activities (Box). Only five did not mention research. Of the 12 colleges using a points‐based system, 11 allocated points only to leading research — where the application specifically states that the applicant must be first or second author on journal articles, primary presenter at conferences, or take a leadership role in research — nine of which required this research to be conducted in the previous 4–5 years. Ten made some reference to quality, although these were often vague or generic (Box). Research was worth a median of 25% of the curriculum vitae (CV), and 7% of the overall application. This represents a numerically small but critical proportion of the overall application, since research is often used to differentiate candidates, despite number of publications at training entry being negatively correlated with clinical performance.3 As put by Doug Altman, “The length of a list of publications is a dubious indicator of ability to do good research; its relevance to the ability to be a good doctor is even more obscure”.4 No colleges allocated points for research utilisation, research training, or participation in large research teams. It appears to be far more advantageous for applicants to complete several small, low impact projects within a short time frame as first author than a single well designed randomised controlled trial as middle author. This focus on leading research leaves junior doctors vulnerable to poor quality research experiences and outputs without structured guidance and supervision.5 The current selection criteria for college training programs encourage high volume, CV‐padding research with little regard for quality or value‐adding to their field. The value of using or participating in research is apparently ignored, reducing incentives for doctors to learn good research practices and progressively acquire research skills. We posit that this is contributing to research waste. Box – Research selection criteria for applications to Australian and New Zealand medical specialty college training programs Research selection criteria Colleges n (%) Total number of colleges 63 Colleges with publicly available application documents 61/63 (97%) Mandatory 0/63 (0%) Encouraged 46/63 (73%) Encouraged with points 12/63 (19%) Authorship priority* 11/12 (92%) Research topic must be specialty‐specific 5/12 (42%) Time limit (median) 9/12 (75%)† Quality 10/12‡ (83%) Not mentioned 5/63 (8%) * First or second authorship on journal articles or primary presenter at conferences. † One college had a limit of 4 years; all others had a limit of 5 years. ‡ Quality — any mention, including peer‐reviewed, impact factor of journals, and fewer points for case reports.

Caitlyn Withers · Christy Noble · Caitlin Brandenburg · Paul P Glasziou · Paulina Stehlik

A longer surveillance interval may entail an unacceptably increased level of risk of advanced neoplasia

Zaki Hamarneh · Charles Cock · Graeme P Young · Peter A Bampton · Robert Fraser · Fang LI Ang · Feruza Kholmurodova · Erin L Symonds

If suitable mosquito vectors are present in a region, returning infected travellers can initiate local transmission

Annelies Wilder‐Smith

Estimating expected background rates of hospital transfer and death can inform analyses of vaccine safety

Hazel J Clothier · Yonatan M Mesfin · Steven Strange · Jim P Buttery

To the Editor: The explanation of inference from confidence intervals by Hemming and Taljaard is interesting but unfortunately incorrect.1 The authors may have fallen for the confidence interval variation of the P value fallacy — the mistaken idea that the P value (or confidence interval) can capture both the long term outcomes of an experiment, as commonly reflected in the phrase “a trend to significance (P = 0.06)”, and the evidential meaning of a single result.2 In a frequentist approach, the P value follows from the null hypothesis, which is either accepted or rejected. The calculation of the P value proceeds only because we have accepted the null hypothesis to be true. Are Hemming and Taljaard confusing Bayesian and frequentist inferential methods?3 The difference between Bayesian and frequentist logic is analogous to the diagnosis of measles for a hypothetical patient presenting with a fever and a rash.4 With frequentist logic, we would consult a text book (the correct textbook being a key assumption), and base our diagnostic inference on a hypothetical cohort of 100 patients presenting to us with an identical rash and fever, to state that 95 of them would have measles. We would not be able to state which of this hypothetical group of individuals had measles. Moreover, a diagnosis of “a trend to measles (P = 0.06)” does not exist in the real world. By contrast, with Bayesian logic, our hunch (the prior) that the patient in front of us has measles is firmed up (the posterior) by knowing that there is a measles outbreak in the community (the evidence). Unfortunately, the thinking commonly found in association with P values and 95% confidence intervals, and suggestions that directive conclusions from randomised trials are achievable from borderline P values, leads to terms such as “a trend to significance” for findings from studies that are underpowered.5

James C Hurley

Stillbirth and cancer rates are significantly elevated among Aboriginal people living near the Ranger uranium mine Stillbirth and cancer incidence rates are significantly higher among Aboriginal people living near the Ranger uranium mine than among Aboriginal people elsewhere in the Top End of the Northern Territory, with a stillbirth rate over twice as high and cancer incidence almost 50% higher.1 The NT Chief Health Officer commissioned an investigation into the excess stillbirths and cancers in 2014, but a November 2020 report found no explanatory cause.1 The Ranger uranium mine ceased operations as planned in January 2021.2 Communities expect health departments to respond to reports of clusters of adverse health outcomes such as the excess stillbirths and cancers among Aboriginal people living near the Ranger uranium mine.3 However, investigating clusters of health outcomes which have complex aetiologies rarely provides definitive answers.3 Even when associations are identified, cluster investigations cannot demonstrate that these associations are responsible for the disease cluster. Nonetheless, important environmental, public health and social problems may be identified through cluster investigations, enabling health education and promotion, and potentially, mitigation of contributing causes.3 The Ranger mine cluster investigation focused on ionising radiation as a potential cause of the excess stillbirths and cancers because this was considered the worst‐case scenario.1 There are well established causative associations between ionising radiation and increased rates of some cancers, particularly lung, head and neck, thyroid cancer in childhood and leukaemia, and fetal malformations that lead to stillbirth.1 Tobacco and alcohol consumption likewise contribute to stillbirths and cancers, and these were also examined in the cluster investigation, together with markers of poor nutrition.1 High levels of alcohol consumption by Aboriginal people in the Ranger mine region have long been a concern.4,5 The Ranger uranium mine in Kakadu National Park Uranium mining began at a location labelled “Ranger” in 1980 on land excised from the Kakadu National Park World Heritage site.6 Aboriginal rights to veto mining were overridden in legislation, and detrimental impacts on Aboriginal people were anticipated, but market prospects for uranium appeared strong and the mine was considered to be in the national interest. Mining was allowed to proceed, with recommendations to monitor and reduce harmful impacts on the region’s Aboriginal people.4,7 Health, social and ecological aspects of the Ranger uranium mine were explored in a 1984 report, whose authors recognised that their immersion into Aboriginal communities gave them deep concern about how uranium mining could affect Aboriginal people.5 They recommended that uranium mining not expand without interventions to mitigate harmful and strengthen positive effects of mining on Aboriginal people.5 Mining continued for 40 years, and the Ranger uranium mine contributed up to $388 million annually to the NT economy before its 2021 closure.2,8 During the period of mine operation, more than 200 leaks, spills and other incidents were documented.9 Five major incidents are outlined in Box 1, highlighting threats to ecosystems and employees more than radiation exposure among Aboriginal community residents.9,10 The Gundjeihmi Aboriginal Corporation represents the Mirarr people of the region and for decades has expressed grave concerns about continuing incidents and the lack of effective government response.7 While the Mirarr people maintain the right to live on their lands, their lives are disrupted by mining operations and incidents that threaten biodiversity, landscapes and livelihoods.7,9 In 2014, the mine operators lodged a proposal to expand. A submission on the proposal by the NT Department of Health noted that rates of stillbirth and cancer among Aboriginal people in the region were elevated.1 NT Department of Health investigation In 2014, the NT Chief Health Officer commissioned an investigation into stillbirth and cancer rates in long term Aboriginal residents around the Ranger mine. The investigation aimed to quantify rates and identify exposures that may have contributed to the excess stillbirths and cancers. Stakeholders including Aboriginal health and land corporations and public health and politics experts oversaw the investigation to ensure transparency, while independent epidemiologists scrutinised the investigation’s scope, design and conduct. The investigation report was released publicly in November 2020.1 The investigation identified all Aboriginal people who had spent more than half of their lives in the mine region during the 1991–2014 study period, with an exposed cohort of about 2200 people. The focus was ionising radiation because this exposure was considered the worst‐case scenario.1 The mine employed few local Aboriginal people, so occupational exposures were not considered.1,2 The comparison group comprised all other Aboriginal people in the Top End.1 Elevated stillbirth and cancer incidence rates among Aboriginal people living near the Ranger mine compared with other Aboriginal people in the Top End were confirmed. Stillbirth was over twice as common (odds ratio, 2.17; 95% CI, 1.13–3.82) and cancer about 50% more common (total cancer incidence ratio, 1.48; 95% CI, 1.17‐1.85).1 Examination of the cancer types showed that no specific cancer was responsible for the excess of total cancers. Cancers of the lip, mouth and pharynx together were the most common cancers and made up 42% of the excess: 16 cases, compared with 5.5 expected. These cancers are not considered to be caused by ionising radiation, but they are associated with tobacco smoking and alcohol consumption.1 The Aboriginal people living near the mine had higher prevalence of tobacco smoking (prevalence ratio, 1.08; 95% CI, 1.04–1.13), alcohol use (prevalence ratio, 1.21; 95% CI, 1.13–1.31) and infrequent intake of vegetables indicating poor nutrition (prevalence ratio, 1.08; 95% CI, 1.02–1.24) compared with other Aboriginal people in the Top End. Other risk factors were not statistically different between the groups. Multivariable analysis did not show that these risk factors contributed to the excess cancer incidence in the people living near the mine (Box 2). However, this analysis had low statistical power because of a lack of risk factor data.1 The investigation found “little evidence that the risk factors investigated … were associated with increased risk of cancer in study participants” in the period for which risk factor data were available.1 Despite this statistical conclusion, higher rates of tobacco smoking and alcohol use and poor diets among Aboriginal people in the mine region were highlighted in relation to the excess stillbirths and cancers. The investigation concluded by recommending that Aboriginal people follow advice about smoking, alcohol and diet.1 Discussion The Ranger uranium mine has had an impact on surrounding Aboriginal communities for over 40 years. The investigation by the NT Department of Health into the rates of stillbirths and cancers among people in the region invested significant resources and expertise in gathering data on stillbirths, cancers, ionising radiation and behavioural risk factors. It focused on cause–effect relationships between possible exposure to ionising radiation and behavioural risk factors, and the increased stillbirth and cancer rates. The investigation was not designed to consider the impact of the imposition of uranium mining on Aboriginal lands, as was recommended when the mine was proposed and developed.4,5 Development of the Ranger mine entailed nullification of veto rights, disempowering Aboriginal communities and threatening their livelihoods.7 With mining came royalty money, expensive commodities, money‐hunger and alcohol.5 Economic development from the mine has increased inequity among Aboriginal people in the region.5 Inequity may contribute to both stillbirths and cancer, although this would not be detected in a cluster investigation.3,11,12 Employment and educational opportunities associated with the Ranger mine did not promote socio‐economic development of the Aboriginal community; rather, Aboriginal wellbeing deteriorated through people relying on royalty income.2,7 Aboriginal people’s rights were ignored, and their expertise, authority and lifeways were devalued by the mine.7 Aboriginal community perspectives, knowledge and research methodologies may offer important insights into adverse Aboriginal health outcomes, while marginalising Aboriginal expertise perpetuates the impacts of colonisation.13 Excess stillbirths and cancers may be associated with a web of interrelationships between individuals, communities and wider ecological, sociological and political environments, which a biomedically focused investigation may overlook.14 Further research is needed to unravel this web, and explain the disparity in stillbirth and cancer rates between Aboriginal people in the region of the mine and the other Aboriginal people in the Top End. The NT Department of Health stillbirth and cancer cluster investigation recommended that Aboriginal people in the region reduce their tobacco and excessive alcohol consumption, although these were not considered the causes of the raised stillbirth and cancer rates.1 This response could be strengthened by a foundational approach to improve understanding and relationships between government, mining companies and Aboriginal community members.2 Conclusion The investigation by the NT Department of Health into the excess stillbirths and cancers among Aboriginal people living near the Ranger uranium mine was transparent, detailed and publicly available. High level expertise was engaged, although stronger Aboriginal contribution to the investigation’s grounding and methodology may have enhanced two‐way intercultural learning.13 Research from Aboriginal community perspectives that focuses on improving health and wellbeing may lead to possible interventions. While the mine is now closed and undergoing rehabilitation, there is an opportunity for further research to better understand and close the gap in health risk exposures and outcomes between Aboriginal people in the region of the mine and other Aboriginal people in the Top End. Box 1 – Major incidents at the Ranger uranium mine, 1979–20139,10 Date Location Incident Outcome Risk minimisation December 1995 Retention pond 2 at power station 12 000 litres of diesel fuel spilled World’s richest tropical waterbird breeding ground threatened; 40 identified waterbirds perished Office of Supervising Scientist designated this as unacceptable environmental impact. Increases in monitoring not implemented due to mine operator’s other commitments January–April 2002 Headwaters of Corridor Creek, southern side of mine Incorrect stockpiling of low grade uranium ore Water contaminated by leakage of uranium Remedial works undertaken in February 2002. No source found for ongoing run‐off identified in April March 2004 Ranger mine utility site Process water connected to drinking water, leading to water uranium levels 400 times Australian standards 159 workers potentially exposed to contaminated water for drinking and washing Mine operator prosecuted and fined $150 000 January–June 2011 Region wide Extreme wet season Risk of overflow from tailings dam Uranium mill was shut for duration of wet season December 2013 Ranger mine site Collapse of acid leach tank 1 million litres of radioactive ore slurry spilled Area was evacuated until spill contained Box 2 – Total cancer incidence rate ratios for Aboriginal people living near the mine compared with other Aboriginal people in the Top End of the Northern Territory, by selected risk factors*,1 Risk factor Cancer incidence rate ratio (95% CI) Tobacco smoking 1.53 (0.75–3.12) Alcohol use 1.54 (0.76–3.15) Infrequent vegetable intake 1.49 (0.73–3.06) * Poisson regression model adjusted for age and sex.

Rosalie Schultz

Developing a pathway to prioritise clinical research and prepare for future pandemics remains an urgent need

Asha C Bowen · Steven YC Tong · Joshua S Davis

The research response in Australia has been rapid, but better coordination is imperative

Anna Lene Seidler · Mason Aberoumand · Jonathan G Williams · Aidan Tan · Kylie E Hunter · Angela Webster

To the Editor: In their article, Blakely and colleagues1 describe an infectious disease model for simulating the effect of a lockdown on the transmission of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2). Although we cannot say this work determined pandemic policy, two of the authors have described their close collaboration with the Victorian Government, culminating in the release of a road map to reopening2 based directly on, and released alongside, their modelling.3 The model is stochastic and agent‐based, with 2500 individuals moving around a model space. When both an infected and a susceptible person land on the same patch, there is a probability of transmission. Some individuals are marked as being essential workers; population homogeneity is otherwise assumed.4 Models are necessarily abstractions from reality; it is neither possible nor relevant to include every population group. The question is whether the model effectively captures the dynamics of infection. The combination of model type and population structure has a surprising result. People in the model can only be infected by moving around, and a lockdown is simulated by a reduction in the pace and frequency of movement. At a technical level, the model’s mechanics guarantee the effectiveness of a population‐wide lockdown because it most extensively reduces movement. It is hardly surprising that Blakely and colleagues refer to a lockdown as an “opportunity”.1 The assumption of population homogeneity is robust to exceptions, but only to a point. Using official data, we estimate that, in Victoria, the odds of an aged care worker becoming infected were almost 12 times that of the general population (odds ratio [OR], 11.81; 95% CI, 11.76–11.87). For health care workers, the odds were more than three times higher (OR, 3.19; 95% CI, 3.14–3.23).5 At this level of contact and risk heterogeneity, the model cannot reflect the true virus dynamics. Throughout the period covered by the model predictions, interventions targeted at health care settings were implemented. These interventions, such as closing hospital tea rooms and changing aged care working conditions, cannot be factored into the model predictions because health and aged care workers are not included in the model. By failing to specifically consider the populations that drove the epidemic or the interventions targeted at those populations, any ultimate concurrence between the actual and predicted numbers can only be attributable to chance.

Bradley R Crammond · Vishaal Kishore

On 23 May 2019, the Central Queensland Public Health Unit received a confirmed laboratory notification of a dengue virus serotype‐2 (DENV‐2) infection in a Rockhampton resident. On 5 May, a 71‐year‐old man without a history of travel overseas or to Far North Queensland had developed symptoms consistent with a zoonotic disease, and presented later that month to his general practitioner because his symptoms had not abated. Between 23 May and 7 October 2019, 21 locally acquired cases of DENV‐2 were identified in Rockhampton: 13 laboratory‐confirmed cases and eight probable cases detected by active surveillance. This was the first outbreak of locally acquired dengue in Central Queensland for 65 years.1 In 14 cases (67%), the infected persons sought medical attention; two required hospitalisation. A formal outbreak response was initiated by the Central Queensland Public Health Unit on 23 May 2019, including extensive mosquito surveillance and active and passive human surveillance within 200 metres of the residences of each identified infected person. Particular attention was directed to surveying locations that might facilitate increased dengue transmission in the community (such as schools, a plant nursery, and aged care facilities) for artificial and natural containers that could serve as breeding areas for infected mosquitoes (Aedes aegypti). Such containers were either removed or emptied of residual water and treated with pellets of the insect growth regulator (S)‐methoprene, and the premises and buildings were sprayed inside and out with the residual insecticide Temprid 75 (Bayer; includes imidacloprid and β‐cyfluthrin). In addition to the house‐to‐house human surveillance, a novel “lure and kill” approach was adopted for vector control: lethal ovitraps were deployed within 200 metres of the residence of any person with a probable or confirmed infection. Ae. aegypti was found in 105 of 1107 inspected residential premises (9.5%), or more than half of the 205 premises found to contain mosquitoes. Enhanced serological surveillance was undertaken to detect patients with viraemia early, enabling prompt public health and mosquito control interventions. The complete DENV‐2 genome sequence (GenBank accession number, MN982899.1) indicated that the implicated virus was most closely related to Southeast Asian strains of DENV‐2. Given the presence of Ae. aegypti in Central Queensland and the increasing numbers of travellers and visitors returning from countries in which dengue is endemic, it is important that Rockhampton be recognised as a dengue‐receptive area. As locally acquired cases of dengue are being reported outside Far North Queensland, the state map of dengue‐receptive areas2 should be updated; specifically, the broad geographic area from Townsville south to Rockhampton should be considered dengue‐receptive.

Jacina Walker · Alyssa Pyke · Paul Florian · Rachael M Rodney Harris · Gulam Khandaker

Overlooking the potential for airborne transmission of SARS-CoV-2 leaves Australia vulnerable to outbreaks

Zoë Hyde · David Berger · Andrew Miller

Understanding the mental shortcuts people make and the values they bring to weighing risks is critical to informing effective risk communication

Julie Leask · Samantha J Carlson · Katie Attwell · Katrina K Clark · Jessica Kaufman · Catherine Hughes · Jane Frawley · Patrick Cashman · Holly Seal · Kerrie Wiley · Katarzyna Bolsewicz · Maryke Steffens · Margie H Danchin

National surveillance would facilitate strategies for preventing or managing conditions that predispose people to severe streptococcal disease

Jeffrey W Cannon · Asha C Bowen

The social determinants of incidence should be addressed, and other relevant host, pathogen, and health system factors investigated

Cameron M Wright · Rachael Moorin · Glenn Pearson · John R Dyer · Jonathan R Carapetis · Laurens Manning

Genomic surveillance enhances detection and response to emerging SARS-CoV-2 variants

Patiyan Andersson · Norelle L Sherry · Benjamin P Howden

A new clinical trials network aims to bridge the gap in cancer outcomes between rural and metropolitan cancer patients in Victoria

Arun Muthusamy · Donna Long · Craig R Underhill

Objective: To assess long term survival and patient characteristics associated with survival following acute myocardial infarction (AMI) in Australia and New Zealand. Design: Cohort study. Setting, participants: All patients admitted with AMI (ICD‐10‐AM codes I21.0‒I21.4) to all public and most private hospitals in Australia and New Zealand during 2009‒2015. Main outcome measure: All‐cause mortality up to seven years after an AMI. Results: 239 402 initial admissions with AMI were identified; the mean age of the patients was 69.3 years (SD, 14.3 years), 154 287 were men (64.5%), and 64 335 had ST‐elevation myocardial infarction (STEMI; 26.9%). 7‐year survival after AMI was 62.3% (STEMI, 70.8%; non‐ST‐elevation myocardial infarction [NSTEMI], 59.2%); survival exceeded 85% for people under 65 years of age, but was 17.4% for those aged 85 years or more. 120 155 patients (50.2%) underwent revascularisation (STEMI, 72.2%; NSTEMI, 42.1%); 7‐year survival exceeded 80% for patients in each group who underwent revascularisation, and was lower than 45% for those who did not. Being older (85 years or older v 18–54 years: adjusted hazard ratio [aHR], 10.6; 95% CI, 10.1–11.1) or a woman (aHR, 1.15; 95% CI, 1.13–1.17) were each associated with greater long term mortality during the study period, as was prior heart failure (aHR, 1.79; 95% CI, 1.76‒1.83). Several non‐cardiac conditions and geriatric syndromes common in these patients were independently associated with lower long term survival, including major and metastatic cancer, cirrhosis and end‐stage liver disease, and dementia. Conclusion: AMI care in Australia and New Zealand is associated with high rates of long term survival; 7‐year rates exceed 80% for patients under 65 years of age and for those who undergo revascularisation. Efforts to further improve survival should target patients with NSTEMI, who are often older and have several comorbid conditions, for whom revascularisation rates are low and survival after AMI poor.

Bora Nadlacki · Dennis Horton · Sadia Hossain · Saranya Hariharaputhiran · Linh Ngo · Anna Ali · Bernadette Aliprandi‐Costa · Chris J Ellis · Robert JT Adams · Renuka Visvanathan · Isuru Ranasinghe

Objectives: To estimate initial levels of symptoms of depression and anxiety, and their changes during the early months of the COVID‐19 pandemic in Australia; to identify trajectories of symptoms of depression and anxiety; to identify factors associated with these trajectories. Design, setting, participants: Longitudinal cohort study; seven fortnightly online surveys of a representative sample of 1296 Australian adults from the beginning of COVID‐19‐related restrictions in late March 2020 to mid‐June 2020. Main outcome measures: Symptoms of depression and anxiety, measured with the Patient Health Questionnaire (PHQ‐9) depression and Generalised Anxiety Disorder (GAD‐7) scales; trajectories of symptom change. Results: Younger age, being female, greater COVID‐19‐related work and social impairment, COVID‐19‐related financial distress, having a neurological or mental illness diagnosis, and recent adversity were each significantly associated with higher baseline depression and anxiety scores. Growth mixture models identified three latent trajectories for depression symptoms (low throughout the study, 81% of participants; moderate throughout the study, 10%; initially severe then declining, 9%) and four for anxiety symptoms (low throughout the study, 77%; initially moderate then increasing, 10%; initially moderate then declining, 5%; initially mild then increasing before again declining, 8%). Factors statistically associated with not having a low symptom trajectory included mental disorder diagnoses, COVID‐19‐related financial distress and social and work impairment, and bushfire exposure. Conclusion: Our longitudinal data enabled identification of distinct symptom trajectories during the first three months of the COVID‐19 pandemic in Australia. Early intervention to ensure that vulnerable people are clinically and socially supported during a pandemic should be a priority.

Philip J Batterham · Alison L Calear · Sonia M McCallum · Alyssa R Morse · Michelle Banfield · Louise M Farrer · Amelia Gulliver · Nicolas Cherbuin · Rachael M Rodney Harris · Yiyun Shou · Amy Dawel

Improving integrated care and systematically targeting major cancer and non- cancer causes of morbidity and mortality could yield major benefits

Emily Banks · Grace Joshy

To the Editor: The clinical trial landscape has arguably progressed more in the past 6 months than in the previous 10 years. The needs of humanity in the global pandemic catalysed the necessity to evaluate study design, implementation, governance, technology and collaboration. The race for effective therapies and a vaccine highlighted the need to expedite drug development and approval. While clinical trials in oncology have used master protocols for many years, with clear guidance from regulatory authorities1 and a gradual adoption in other therapeutic areas,2 these have become the blueprint for coronavirus disease 2019 (COVID‐19) clinical trials developed by the World Health Organization, ensuring the ability to test a broad range of therapies. COVID‐19 has also triggered the adoption of technology to support trials, accelerating the move to a digital age of clinical trials.3 Platforms to deliver online recruitment, electronic consent, wearable devices, artificial intelligence and electronic systems for source data and regulatory documents now provide the solution to maintaining clinical trials activity, at a time when restrictions challenge the viability of face to face trial operations. The need for comprehensive, integrated electronic medical records is evident, with enduring access for parties for data verification, but raises issues of access, privacy and cybersecurity. Out of necessity, clinical trials have also adopted teletrials, like the need in medical practices to adopt telemedicine,4 resulting in a dispersed, decentralised model of operation. The pressure to adapt clinical trial delivery has seen previously perceived barriers fall away. By focusing on common goals, collaboration, technology, and building solid foundations to evaluate our progress to ensure research integrity and safety, a new era of clinical trials will unfold. The clinical trials team of the future will evolve, incorporating a core team with information and communication technology capabilities to support training, management and development of trial systems in a networked model of delivery. While this is a welcome push into a new technological era, with an opportunity to retain new elements and abandon outdated models, we must proceed with thoughtful consideration and evaluation of our progress.

Alana Sarah · Olivia Dean · Michael Berk