TY - JOUR
T1 - Recruiting ENT and Audiology patients into pharmaceutical trials
T2 - evaluating the multi-centre experience in the UK and USA
AU - Sanchez, Victoria A.
AU - Hall, Deborah A.
AU - Millar, Bonnie
AU - Escabi, Celia D.
AU - Sharman, Alice
AU - Watson, Jeannette
AU - Thasma, Sornaraja
AU - Harris, Peter
N1 - Funding Information:
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.
Funding Information:
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.
Funding Information:
The purpose of this report is to describe the recruitment monitoring and subsequent adjustment of various study procedures and describe the recruitment methods for two hearing-related phase IIa pharmaceutical RCTs: Quest In Eliminating Tinnitus (QUIET-1) in England and CLARITY-1 in the US. Each RCT tested the same novel drug compound for associated hearing-related problems. The sponsor for both trials was the same, Autifony Therapeutics Ltd, despite the populations recruited being different across the two RCTs with different regulatory requirements based on country having an influence on methodologies. Clinical trial support was provided in both trials by the same ISO-certified international Contract Research Organization (CRO), CROMSOURCE. Hearing expertise support was provided to the sites by two academic partners: the University of Nottingham for QUIET-1 and the University South Florida (USF) for the CLARITY-1. Using data from the academic partners, our aim was to evaluate the recruitment monitoring and subsequent adjustment of various study procedures (e.g. eligibility criteria, increasing recruiting sites and recruitment methods) and report the efficiency of recruitment and screening methods to achieve the planned sample size.
Publisher Copyright:
© 2018, © 2018 British Society of Audiology, International Society of Audiology, and Nordic Audiological Society.
PY - 2018/8/24
Y1 - 2018/8/24
N2 - 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.
AB - 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.
KW - aging
KW - Pharmacology
KW - speech perception
KW - tinnitus
UR - http://www.scopus.com/inward/record.url?scp=85041108396&partnerID=8YFLogxK
U2 - 10.1080/14992027.2018.1425002
DO - 10.1080/14992027.2018.1425002
M3 - Article
C2 - 29355055
AN - SCOPUS:85041108396
SN - 1499-2027
VL - 57
SP - S55-S66
JO - International Journal of Audiology
JF - International Journal of Audiology
IS - sup4
ER -