Related Experiment Video
Updated: Jan 6, 2026
A High-Throughput Multiplexed Screening for Type 1 Diabetes, Celiac Diseases, and COVID-19
Published on: July 5, 2022
A high-volume, low-cost approach to participant screening and enrolment: Experiences from the T4DM diabetes
Karen Bracken1, Anthony Keech1, Wendy Hague1
1NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia.
Background/Aims:
Participant recruitment to diabetes prevention randomised controlled trials is challenging and expensive. The T4DM study, a multicentre, Australia-based, Phase IIIb randomised controlled trial of testosterone to prevent Type 2 diabetes in men aged 50-74 years, faced the challenge of screening a large number of prospective participants at a small number of sites, with few staff, and a limited budget for screening activities. This article evaluates a high-volume, low-cost, semi-automated approach to screen and enrol T4DM study participants.
Methods:
We developed a sequential multi-step screening process: (1) web-based pre-screening, (2) laboratory screening through a network of third-party pathology centres, and (3) final on-site screening, using online data collection, computer-driven eligibility checking, and automated, email-based communication with prospective participants. Phone- and mail-based data collection and communication options were available to participants at their request. The screening process was administered by the central coordinating centre through a central data management system.
Results:
Screening activities required staffing of approximately 1.6 full-time equivalents over 4 years. Of 19,022 participants pre-screened, 13,108 attended a third-party pathology collection centre for laboratory screening, 1217 received final, on-site screening, and 1007 were randomised. In total, 95% of the participants opted for online pre-screening over phone-based pre-screening. Screening costs, including both direct and staffing costs, totalled AUD1,420,909 (AUD75 per subject screened and AUD1411 per randomised participant).
Conclusion:
A multi-step, semi-automated screening process with web-based pre-screening facilitated low-cost, high-volume participant enrolment to this large, multicentre randomised controlled trial. Centralisation and automation of screening activities resulted in substantial savings compared to previous, similar studies. Our screening approach could be adapted to other randomised controlled trial settings to minimise the cost of screening large numbers of participants.
Insights
Recruiting for diabetes prevention trials is hard. A semi-automated, multi-step screening process, including web-based pre-screening, successfully enrolled participants in a testosterone trial at low cost.
Area of Science:
- Clinical Trials
- Endocrinology
- Public Health
Background:
- Participant recruitment for diabetes prevention randomized controlled trials (RCTs) presents significant challenges in terms of cost and logistics.
- The Testosterone for Diabetes Management (T4DM) study, a Phase IIIb RCT, aimed to prevent Type 2 diabetes in men aged 50-74 years, facing high screening volume demands with limited resources.
- This study evaluates an innovative, cost-effective, semi-automated screening strategy designed for high-volume participant enrollment.
Purpose of the Study:
- To assess the efficacy of a semi-automated, multi-step screening process for participant recruitment in a large, multicenter diabetes prevention RCT.
- To determine the cost-effectiveness and efficiency of a centralized, web-based screening approach compared to traditional methods.
- To provide a scalable model for participant screening in similar clinical trial settings.
Main Methods:
- A sequential, multi-step screening protocol was implemented, starting with web-based pre-screening, followed by laboratory screening at third-party centers, and concluding with on-site screening.
- Online data collection, automated eligibility checks, and email-based communication were utilized, with phone and mail options available upon request.
- The entire screening process was managed centrally by the coordinating center through a unified data management system.
Main Results:
- The screening process required approximately 1.6 full-time equivalents over 4 years, screening 19,022 participants.
- Out of 19,022 pre-screened individuals, 1007 were ultimately randomized into the trial.
- The total cost for screening was AUD 1,420,909, equating to AUD 75 per subject screened and AUD 1411 per randomized participant, with 95% opting for online pre-screening.
Conclusions:
- A multi-step, semi-automated screening approach, particularly with web-based pre-screening, effectively facilitated low-cost, high-volume participant enrollment for a large, multicenter RCT.
- Centralization and automation of screening procedures led to significant cost savings compared to previous studies.
- The developed screening methodology is adaptable to other RCT settings, offering a viable strategy to minimize participant screening costs.
