Recruitment of patients into head and neck clinical trials: acceptability of studies to patients from perspective of the research team

• Main Authors: Cardale, K. (Author), Dyker, K. (Author), Gilbert, K. (Author), Ho, M.W (Author), Johnson, J. (Author), McCaul, J.A (Author), Pick, A.S (Author), Quantrill, J. (Author), Sutton, D.N (Author)
• Format: Article
• Language: English
• Published: Churchill Livingstone 2018
• Subjects: Acceptability clinical trials; adult; article; Clinical trials; controlled study; female; head; Head and Neck Neoplasms; Head and Neck research; head and neck tumor; human; Humans; intervention study; major clinical study; male; medical research; neck; Observational Studies as Topic; observational study; Patient Acceptance of Health Care; patient attitude; patient preference; Patient Preference; patient selection; Patient Selection; personnel; procedures; prospective study; randomization; randomized controlled trial; randomized controlled trial (topic); Randomized Controlled Trials as Topic; Research Personnel; standards; statistics and numerical data; study design; Trial design; Trial recruitment
• Online Access: View Fulltext in Publisher
• ISBN: 02664356 (ISSN)
• DOI: 10.1016/j.bjoms.2018.02.005

We reviewed longitudinal recruitment data to assess recruitment into head and neck cancer trials, and to identify factors that could influence this and affect their acceptability to patients. We retrieved data from the prospective computerised database (2009–2016) to measure acceptability to patients using the recruitment:screening ratio, and compared observational with interventional studies, single specialty (or site) with multispecialty (or site) studies, and “step-up” randomisation with “non-inferiority” randomisation designs. A total of 1283 patients were screened and 583 recruited. The recruitment:screening ratio for all National Institute for Health Research (NIHR) portfolio studies combined was 0.47 (486/1133). Studies that involved treatment by several specialties or at several sites had a significantly adverse impact on acceptability (p = 0.01). Recruitment into non-inferiority randomised controlled studies was lower than that into step-up randomised studies (p = 0.06). The complexity of a study's design did not compromise recruitment. Treatment across several specialties or several sites and perceived non-inferiority designs, reduced the acceptability of some trials. © 2018