Clinical trials site recruitment optimisation: Guidance from Clinical Trials: Impact and Quality.

BACKGROUND/AIMS: Participants are integral to the success of any clinical research study, yet participant recruitment into clinical trials poses ongoing and complex challenges. It is widely accepted and recognised that clinical trial sites often find it difficult to meet recruitment goals, both in terms of accrual targets and timelines. This can impact the validity of trials or cause major delays for research. There are very few frameworks available to clinical trial sites to improve recruitment. The GREET project (Guidance to Recruitment: Examining Experiences at clinical Trial sites) sought to identify barriers to recruitment and produce formal guidance to optimise recruitment outcomes. METHODS: Clinical Trials: Impact and Quality, a collaborative of sector stakeholders, convened a project team with comprehensive knowledge of the Australian clinical trials sector to undertake the GREET project. The project scope included exploration of recruitment issues at a site level across all phases of clinical trials and all types of trial sites. The scope excluded upstream issues such as protocol design and general public clinical trial awareness, participant retention and elements of recruitment outside a site's capacity to directly influence or control. The project team's extensive knowledge and experience conducting clinical trials in Australia was used to collaboratively identify a list of 24 key barriers and 12 enablers to site recruitment which formed the basis of the project. Key stakeholder groups were surveyed to challenge project team assumptions. A national and international environmental scan and literature review was conducted to identify best-practice recruitment solutions. RESULTS: A total of 343 people responded to a survey sent to sites, sponsors, and contract research organisations, and 162 people responded to a survey sent to consumers via consumer networks. The key barriers and enablers initially identified by the project team aligned with the key outcomes of the surveys, which in turn assisted in the development of best-practice recommendations in the form of a Clinical Trial Site Recruitment Guide. Recommendations were grouped into four key themes; conducting accurate study feasibility; proactive planning during start-up; selecting optimal recruitment methods; and participant involvement. Early intervention was identified as a key facilitator in maximising improved recruitment outcomes. The GREET Clinical Trial Site Recruitment Guide is publicly accessible on the Clinical Trials: Impact and Quality website. CONCLUSION: Participant recruitment challenges experienced at a site level are widespread and varied, and there is no universal recruitment solution. However, this project identified that there are interventions and assessments that can be proactively implemented and selectively applied to facilitate improved recruitment outcomes.

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.

Clinical trials best practice checklist: Guidance for Australian clinical research sites from CT:IQ.

The Australian clinical trials sector has grown steadily over the past decade, particularly with respect to early phase trials where Australia's research capacity, capability and quality of research is revered. With an increase in the number of internationally sponsored clinical research projects being conducted in Australia, particularly in the early phase setting, there has been a corresponding growth in the number of clinical research sites conducting early phase clinical trials. Australian researchers are guided by a multitude of research codes, guidance and statements which govern the conduct of clinical trials. Although international guidance regarding the conduct of early phase clinical trials exists, there is currently no single source outlining best practice recommendations for the conduct of early phase clinical trials in Australia. In recognition of this Clinical Trials: Impact & Quality (CT:IQ), a collaborative of sector stakeholders, convened a project team with comprehensive knowledge of the Australian clinical trials sector and particularly early phase research, to evaluate and collate broadly applicable and implementable guidance for the conduct of early phase clinical trials. Although the initial intent was to create guidance specific to early phase, we recognize the project outcomes are more broadly implementable irrespective of the research phase and are intended to support all clinical research sites to conduct high-quality clinical trials in Australia.