Poor Accrual in Palliative Research Studies: An Update From the Rapid Response Radiotherapy Program

Abstract

Background: In June 2003, the Rapid Response Radiotherapy Program (RRRP) implemented changes to recruitment strategies in attempts to increase patient accrual to research studies. Such modifications included the use of a dedicated research assistant to screen for and identify eligible study patients, the introduction of more appropriate inclusion criteria, and the switch towards telephone interviews to minimize patient burden. The purpose of this study is to provide an update on patient accrual in the RRRP.

Methods: All patients seen in the RRRP from January 2002 to December 2009 were recorded in a prospective database. Reasons for referral, eligibility for clinical trials, reasons for non-accrual, and various demographics information were recorded. Descriptive statistics summarized findings.

Results: A total of 4726 patient visits were recorded from January 1st, 2002 to December 31st, 2009. Prior to changes, the overall rate of accrual into research studies was 14.9% versus 48.1% after changes were implemented. Patients were not accrued onto studies mainly to due ineligibility according to study protocol. Other reasons such as language barrier (12.1%), physician objection (3.5%), patient declining participation (11.3%) and lack of a research assistant (9.3%) were cited.

Conclusions: Changes in clinical structure and study design can significantly impact accrual patterns in palliative radiotherapy studies. Despite these changes however, the majority of patients are still not enrolled in studies. Therefore additional efforts need to be made to maximize patient accrual and minimize attrition.




World J Oncol. 2011;2(5):217-224
doi: https://doi.org/10.4021/wjon357w