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

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 probl...

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Main Authors: Sanchez, Victoria A., Hall, Deborah A., Millar, Bonnie, Escabi, Celia D., Sharman, Alice, Watson, Jeannette, Thasma, Sornaraja, Harris, Peter
Format: Article
Published: Taylor & Francis 2018
Subjects:
Online Access:https://eprints.nottingham.ac.uk/48957/
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author Sanchez, Victoria A.
Hall, Deborah A.
Millar, Bonnie
Escabi, Celia D.
Sharman, Alice
Watson, Jeannette
Thasma, Sornaraja
Harris, Peter
author_facet Sanchez, Victoria A.
Hall, Deborah A.
Millar, Bonnie
Escabi, Celia D.
Sharman, Alice
Watson, Jeannette
Thasma, Sornaraja
Harris, Peter
author_sort Sanchez, Victoria A.
building Nottingham Research Data Repository
collection Online Access
description 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.
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spelling nottingham-489572020-05-04T19:27:41Z https://eprints.nottingham.ac.uk/48957/ 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 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. Taylor & Francis 2018-01-21 Article PeerReviewed Sanchez, Victoria A., Hall, Deborah A., Millar, Bonnie, Escabi, Celia D., Sharman, Alice, Watson, Jeannette, 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 Pharmacology; Aging; Speech perception; Tinnitus http://www.tandfonline.com/doi/full/10.1080/14992027.2018.1425002 doi:10.1080/14992027.2018.1425002 doi:10.1080/14992027.2018.1425002
spellingShingle Pharmacology; Aging; Speech perception; Tinnitus
Sanchez, Victoria A.
Hall, Deborah A.
Millar, Bonnie
Escabi, Celia D.
Sharman, Alice
Watson, Jeannette
Thasma, Sornaraja
Harris, Peter
Recruiting ENT and audiology patients into pharmaceutical trials: evaluating the multi-center experience in the UK and USA
title Recruiting ENT and audiology patients into pharmaceutical trials: evaluating the multi-center experience in the UK and USA
title_full Recruiting ENT and audiology patients into pharmaceutical trials: evaluating the multi-center experience in the UK and USA
title_fullStr Recruiting ENT and audiology patients into pharmaceutical trials: evaluating the multi-center experience in the UK and USA
title_full_unstemmed Recruiting ENT and audiology patients into pharmaceutical trials: evaluating the multi-center experience in the UK and USA
title_short Recruiting ENT and audiology patients into pharmaceutical trials: evaluating the multi-center experience in the UK and USA
title_sort recruiting ent and audiology patients into pharmaceutical trials: evaluating the multi-center experience in the uk and usa
topic Pharmacology; Aging; Speech perception; Tinnitus
url https://eprints.nottingham.ac.uk/48957/
https://eprints.nottingham.ac.uk/48957/
https://eprints.nottingham.ac.uk/48957/