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

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-centre pharmaceutical randomised 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 and 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) randomised as a percentage of those screened. Study sample: A total of 584 participants completed the pre-screening steps, 491 screened and 169 participants were randomised. 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 enrolment. Conclusion: A diverse portfolio of methods, continuous monitoring, mitigation strategy and adequate resourcing were essential for achieving our recruitment goals.

Key Words:

• Pharmacology
• aging
• speech perception
• tinnitus

Acknowledgements

We thank Theresa H. Chisolm and Matija Daniel for comments on earlier drafts of this manuscript. We thank all participants for their time and effort while enrolled in the studies. For QUIET-1, we thank the clinical and research staff at the following recruiting sites in England: Nottingham University Hospitals NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust, University Hospitals Birmingham NHS Foundation Trust, University College London Hospital NHS Trust, Shrewsbury and Telford Hospital NHS Trust, The Newcastle upon Tyne Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Wigan and Leigh NHS Foundation Trust, Salford Royal NHS Foundation Trust, University Hospital of North Staffordshire NHS Trust, The Pennine Acute Hospitals NHS Trust, Frimley Health NHS Foundation Trust, Portsmouth Hospitals NHS Trust, The Norfolk and Norwich Hospitals NHS Foundation Trust, East and North Hertfordshire NHS Trust and Plymouth Hospitals NHS Trust. Thanks to the British Tinnitus Association for making introductions to Tinnitus Support Groups across England. For CLARITY-1, we thank the clinical and research staff at the following recruiting sites: University of South Florida; Jean Brown Research; Sacramento ENT; Colorado ENT and Allergy; ENT Associates of South Florida; QPS MRA (Miami Research Associates); University of Louisville; Mayo Clinic- Rochester; The University of Mississippi Medical Center; Long Island Jewish Medical Center; PMG Research Inc.; Piedmont Ear, Nose, & Throat Associates and Vanderbilt University Medical Center.

Declaration of interest

AS, JW, ST and PH were employees of Autifony Therapeutics Ltd at the time of the trials. There is no potential conflict of interest since there is no commercial or business interest in the research reported in this article.

QUIET-1 was funded by Innovate UK Ref 35370-247243 (June 2014–August 2016); Charles Large (Principle Investigator) and Deborah A. Hall (Academic Partner). CLARITY-1 was funded by Autifony Therapeutics Ltd.

Supplementary material available online