Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here?

Implementation of decentralized approaches can improve access to clinical trials. The Australian government has focused on a teletrial model, which resources and upskills health care organisations to enable collaboration in trials to extend to rural and remote areas. This commentary describes the Australian teletrial model, its context within the established DCT model, its value, and likely challenges moving forward.

Development of the Consumer Involvement & Engagement Toolkit: a digital resource to build capacity for undertaking patient-centred clinical trials in Australia.

OBJECTIVE: This manuscript describes the novel approach to developing a toolkit to support meaningful consumer involvement in clinical trials in Australia to help guide others in considering the development of similar resources.The toolkit aims to support greater consumer involvement in shaping how clinical research is prioritised, designed and conducted. Type of program or service: A working group of researchers, research organisations and consumers was established to co-develop the Consumer Involvement and Engagement Toolkit (the 'Toolkit'), a digital resource to guide researchers and organisations regarding consumer involvement in clinical trials. FINDINGS: A literature review and international scan of best practice revealed numerous resources outlining best practice for consumer involvement in clinical research and clear evidence of its impact and value. Through a novel content-sharing process, we were able to utilise these resources to develop a comprehensive Toolkit for researchers and research organisations that provides world-class guidance. LESSONS LEARNT: There is a growing movement to ensure consumer involvement in healthcare, including in clinical research. We discovered its proponents were willing to share their tools and resources to promote international consumer involvement. Although these international tools and resources needed adaptation to suit the Australian research environment, this was achievable with far less effort than developing them from scratch.

Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial.

BACKGROUND: For decades, the research community has called for participant information sheets/consent forms (PICFs) to be improved. Recommendations include simplifying content, reducing length, presenting information in layers and using multimedia. However, there are relatively few studies that have evaluated health consumers' (patients/carers) perspectives on the type and organisation of information, and the level of detail to be included in a PICF to optimise an informed decision to enter a trial. We aimed to elicit consumers' views on a layered approach to consent that provides the key information for decision-making in a short PICF (layer 1) with additional optional information that is accessed separately (layer 2). We also elicited consumers' views on the optimal content and layout of the layered consent materials for a large and complex Bayesian adaptive platform trial (the SNAP trial). METHODS: We conducted a qualitative multicentre study (4 focus groups and 2 semi-structured interviews) involving adolescent and adult survivors of Staphylococcus aureus bloodstream infection (22) and their carers (2). Interview transcripts were examined using inductive thematic analysis. RESULTS: Consumers supported a layered approach to consent. The primary theme that emerged was the value of agency; the ability to exert some control over the amount of information read before the consent form is signed. Three other themes emerged; the need to prioritise participants' information needs; the importance of health literacy; the importance of information about a trial's benefits (over its risks) for decision-making and the interplay between the two. CONCLUSIONS: Our findings suggest that consumers may challenge the one-size-fits-all approach currently applied to the development of PICFs in countries like Australia. Consumers supported a layered approach to consent that offers choice in the amount of information to be read before deciding whether to enter a trial. A 3-page PICF was considered sufficient for decision-making for the SNAP trial, provided that further information was available and accessible.

Creating concise and readable patient information sheets for interventional studies in Australia: are we there yet?

BACKGROUND: Participant information sheets and consent forms (PICFs) used in interventional studies are often criticised for being hard to read and understand. We assessed the readability and its correlates of a broad range of Australian PICFs. METHODS: We analysed the participant information sheet portion of 248 PICFs. Readability scores were measured using three formulae: the Flesch Reading Ease, the Flesch-Kincaid Grade Level, and the Simple Measure of Gobbledygook (SMOG). We investigated how various features (including sponsor type and PICF type) correlated with PICF length and readability and examined compliance with other measures known to improve readability. RESULTS: For a sample of 248 PICFs, the mean (standard deviation) Flesch Reading Ease score was 49.3 (5.7) and for the Flesch-Kincaid Grade Level 11.4 (1.1). The mean (SD) SMOG score was 13.2 (0.9). The median document length was 3848 words (8 pages). Commercial PICFs were more than twice as long as non-commercial, but statistically more readable (p = 0.03) when analysed using the SMOG formula. Subgroup analyses indicated that PICFs for self-consenters were statistically more readable than those for proxy consenters. The use of tables, but not the use of illustrations was associated with better readability scores. CONCLUSIONS: The PICFs in our sample are long and complex, and only 3 of the 248 achieved the recommended readability score of grade 8 or below. The broader use of best practice principles for writing health information for consumers and the development of more context-sensitive templates could improve their utility.

Normalising comparative effectiveness trials as clinical practice.

There is a lack of high-quality evidence underpinning many contemporary clinical practice guidelines embedded in the healthcare systems, leading to treatment uncertainty and practice variation in most medical disciplines. Comparative effectiveness trials (CETs) represent a diverse range of research that focuses on optimising health outcomes by comparing currently approved interventions to generate high-quality evidence to inform decision makers. Yet, despite their ability to produce real-world evidence that addresses the key priorities of patients and health systems, many implementation challenges exist within the healthcare environment.This manuscript aims to highlight common barriers to conducting CETs and describes potential solutions to normalise their conduct as part of a learning healthcare system.

Making the move to a learning healthcare system: has the pandemic brought us one step closer?

The notion of a learning healthcare system (LHS) is gaining traction to advance the objectives of high-quality patient-centred care. Within such a system, real-world data analysis, clinical research and health service research are core activities of the health system. To support the transition to an LHS, the Australian Government is implementing the National Clinical Trials Governance Framework, which extends health service accreditation standards to the conduct of clinical trials. This initiative encourages the integration of clinical trials into clinical care and the fostering of a culture of continuous improvement. However, implementing this initiative may prove challenging if health system leaders, clinicians and patients fail to recognise the value of clinical trials as a core health system activity. In this article we describe the enduring value of clinical trials and how the COVID-19 pandemic has enhanced their value by addressing longstanding deficiencies in the way trials are conducted. We also summarise best-practice advice on the embedding of trials into routine health care to enable their integration into health system operations.What is known about this topic?Many healthcare organisations seek to transition to a learning health system. In Australia, National Safety and Quality Health Service Standards, which support the embedding of clinical trials as a core health system activity, have been implemented to catalyse the move.What does this paper add?Because there is little practical advice on how to embed clinical trials into health system operations, this paper summarises best practice. It also provides a rationale for embedding trials as a core health system activity, because the creation of a strong research culture is an important determinant of success.What are the implications for practitioners?The successful transition to an LHS would significantly advance the goals of value-based care.

International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials.

There is intense debate around the use of altered and waived consent for pragmatic trials. Those in favor argue that traditional consent compromises the internal and external validity of these trials. Those against, warn that the resultant loss of autonomy compromises respect for persons and could undermine trust in the research enterprise.This article examines whether international ethical guidelines and the policy frameworks in three countries-the United States, England, and Australia-permit altered and waived consent for minimal-risk pragmatic trials conducted outside the emergency setting. Provisions for both are clearly articulated in U.S. regulations, but many countries do not have equivalent frameworks. Investigators should not assume that all consent models permitted in the United States are legal in their jurisdictions, even if they are deemed ethically defensible.The authors summarize ethical and regulatory considerations and present a framework for investigators contemplating trials with altered or waived consent.