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

Abstract

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.

Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis

“…Our findings echo those reported by Levett et al [ 20 ] who found that sites that had a supportive and defined research trial structure for recruitment in place consistently had better recruitment rates than those that did not. Having a clear recruitment strategy right at the start and assigned responsibilities is an important enabler to recruitment success [ 21 ]. We observe that sites that were more efficient in recruitment dedicated more staff hours to recruitment (Fig.…”

“…Williams et al [ 11 ] reported that GPs located in a high SES area recruited at a lower rate than those in lower SES which contrasts with that reported in ASPREE. Gaining access to research participants in rural or remote areas has been identified as one of the top ten barriers to recruitment [ 21 ], and this is being addressed in Australia through the development of tele-trials and rural practice-based research networks such as the PARTNER network [ 23 ]. It was observed that the study coordinator made more visits to rural sites (7.5 compared to 4.6 for non-rural sites), and this was likely to have contributed to the recruitment efficiency.…”

Technology-assisted adaptive recruitment strategy for a large nation-wide COVID-19 vaccine immunogenicity study in Brunei

“…Time taken for funding and ethics approval would need to be considered and proactively buffered for in the planning stages as the start of recruitment could be delayed and even impact the sample size, especially when the inclusion criteria are time-sensitive ( 80 – 82 ). Although ample preparations have been made, the study was delayed by a few months as the sudden introduction of government-mandated restricted movements in Brunei had halted most research operations when the second wave of the COVID-19 pandemic hit Brunei in August 2021.…”

A randomized controlled trial for evaluating the impact of integrating a computerized clinical decision support system and a socially assistive humanoid robot into grand rounds during pre/post-operative care

“…Vascular and Thoracic Surgery Wards at the University Clinical Center Maribor treat over 4000 individuals annually and it is estimated that roughly 1400 individuals meet the inclusion criteria. However, based on the fact that, in general, at most 30% of participants (or less) consent to the clinical study, 39 we assume that the final number of subjects willing to participate will be much lower. Regarding sample size requirements for the present study, public registries of clinical trials were reviewed.…”