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

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., Thasma, S., & 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: 1708-8186
• Publisher: Taylor and Francis
• Peer Reviewed: Peer Reviewed
• DOI: https://doi.org/10.1080/14992027.2018.1425002
• Keywords: Pharmacology; Aging; Speech perception; Tinnitus
• Public URL: https://nottingham-repository.worktribe.com/output/906114
• Publisher URL: http://www.tandfonline.com/doi/full/10.1080/14992027.2018.1425002
• 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
• Contract Date: Jan 8, 2018