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

Sanchez, Victoria A.; Hall, Deborah A.; Millar, Bonnie; Escabi, Celia D.; Sharman, Alice; Watson, Jeannette; Thasma, Sornaraja; Harris, Peter


Victoria A. Sanchez

Deborah A. Hall

Bonnie Millar

Celia D. Escabi

Alice Sharman

Jeannette Watson

Sornaraja Thasma

Peter Harris


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.


Sanchez, V. A., Hall, D. A., Millar, B., Escabi, C. D., Sharman, A., Watson, J., …Harris, P. (in press). Recruiting ENT and audiology patients into pharmaceutical trials: evaluating the multi-center experience in the UK and USA. International Journal of Audiology,

Journal Article Type Article
Acceptance Date Jan 2, 2018
Online Publication Date Jan 21, 2018
Deposit Date Jan 8, 2018
Publicly Available Date Jan 22, 2019
Journal International Journal of Audiology
Print ISSN 1499-2027
Electronic ISSN 1499-2027
Publisher Taylor & Francis Open
Peer Reviewed Peer Reviewed
Keywords Pharmacology; Aging; Speech perception; Tinnitus
Public URL
Publisher URL
Additional Information This is an Accepted Manuscript of an article published by Taylor & Francis in on International Journal of Audiology, available online: