Recruiting ENT and audiology patients into pharmaceutical trials: evaluating the multi-center experience in the UK and USA

Sanchez, Victoria A. and Hall, Deborah A. and Millar, Bonnie and Escabi, Celia D. and Sharman, Alice and Watson, Jeannette and Thasma, Sornaraja and Harris, Peter (2018) Recruiting ENT and audiology patients into pharmaceutical trials: evaluating the multi-center experience in the UK and USA. International Journal of Audiology . ISSN 1499-2027

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Abstract

Objective: Recruiting into clinical trials on time and on target is a major challenge, and yet often goes unreported. This study evaluated the adjustment to procedures, recruitment, and screening methods in two multi-center pharmaceutical randomized controlled trials (RCTs) for hearing-related problems in adults.

Design: Recruitment monitoring and subsequent adjustment of various study procedures (e.g., eligibility criteria, increasing recruiting sites, recruitment methods) are reported. Participants were recruited through eight overarching methods: trial registration, posters/flyers, print publications, internet, social media, radio, databases, and referrals. The efficiency of the recruitment was measured by determining the number of people: (1) eligible for screening as a percentage of those who underwent telephone pre-screening; and, (2) randomized as a percentage of those screened.

Study sample: A total of 584 participants completed the pre-screening steps, 491 screened, and 169 participants were randomized.

Results: Both RCTs completed adjustments to the participant eligibility, added new study sites, and additional recruitment methods. No single recruitment method was efficient enough to serve as the only route to enrollment.

Conclusions: A diverse portfolio of methods, continuous monitoring, mitigation strategy, and adequate resourcing were essential for achieving our recruitment goals.

Item Type: Article
Additional Information: This is an Accepted Manuscript of an article published by Taylor & Francis in on International Journal of Audiology, available online: http://www.tandfonline.com/10.1080/14992027.2018.1425002
Keywords: Pharmacology; Aging; Speech perception; Tinnitus
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Clinical Neuroscience
Identification Number: https://doi.org/10.1080/14992027.2018.1425002
Depositing User: Hall, Prof Deborah
Date Deposited: 08 Jan 2018 09:31
Last Modified: 16 Feb 2018 06:46
URI: http://eprints.nottingham.ac.uk/id/eprint/48957

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