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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

Authors

Victoria A. Sanchez vasanchez@usf.edu

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DEBORAH HALL Deborah.Hall@nottingham.ac.uk
Professor of Hearing Sciences

Bonnie Millar bonnie.millar@nottingham.ac.uk

Celia D. Escabi criffel@mail.usf.edu

Alice Sharman alice.grant@autifony.com

Jeannette Watson jw@peptinnovate.com

Sornaraja Thasma s.thasma@prorelixresearch.com

Peter Harris peter.harris@autifony.com



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.

Citation

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, https://doi.org/10.1080/14992027.2018.1425002

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
DOI https://doi.org/10.1080/14992027.2018.1425002
Keywords Pharmacology; Aging; Speech perception; Tinnitus
Public URL http://eprints.nottingham.ac.uk/id/eprint/48957
Publisher URL http://www.tandfonline.com/doi/full/10.1080/14992027.2018.1425002
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf
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....0/14992027.2018.1425002

Files

Submission R2 (1).pdf (1.7 Mb)
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Copyright Statement
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf





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