Tribulations of a prostate cancer trial – Lessons learned from TOAD, a Cancer Council Victoria and Transtasman Radiation Oncology Group trial

Abstract

From 2004–2009 a total of 226 out of a target of 750 prostate cancer patients have been randomised into the Timing of Androgen Deprivation trial between immediate and delayed androgen deprivation. A screening log was kept by participating centres for the first 928 patients, which documented the reasons for non-entry into the trial; 42.7% of screened patients were ineligible and a further 33.0% were not entered for other reasons. Fewer than 10% of patients cited not wanting to be part of a clinical trial as a reason for non-entry. Strategies to improve recruitment included broadening the eligibility criteria, encouraging international collaboration, the use and support of research nurses in the private health care environment, and the use of phone follow-up. Recruitment will be completed at the number originally intended to inform the interim analysis designed to test the validity of the statistical assumptions, and a combined survival analysis with the Canadian study is planned.

The MATE trial: a multicentre, mixed-methodology, pilot, randomised controlled trial in neovascular age-related macular degeneration

“…Screen fail rates in the MATE trial were 18.51%, lower than similar previous studies [ 23 – 29 ]. The most common cause of screen fails was not meeting the eligibility criteria, in line with previous research [ 27 , 29 , 30 ]. Protocol amendments aimed to facilitate recruitment are most often made regarding eligibility criteria and account for 16% of all protocol amendments [ 31 ].…”

Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study

“…Recruitment is jeopardised by many factors including restrictive eligibility criteria and inefficient methods for approaching potential participants [5, 6]. Screening logs may help inform the representativeness of a RCT [7], but they may also be informative for understanding why eligible patients are not recruited [8, 9]. …”