BACKGROUND Many cancer interventional clinical trials are not completed because the required number of eligible patients are not enrolled. OBJECTIVE To assess the value of using a research data mart (RDM) during the design of cancer clinical trials as a predictor of potential patient accrual, so that less trials fail to meet enrollment requirements. MATERIALS AND METHODS The eligibility cri...

BACKGROUND Adequate participant recruitment is vital to the conduct of a clinical trial. Projected recruitment rates are often over-estimated, and the time to recruit the target population (accrual period) is often under-estimated. METHODS This report illustrates three approaches to estimating the accrual period and applies the methods to a multi-center, randomized, placebo controlled trial u...

This paper develops a measure of income tax expense accrual quality. Following the framework of Dechow and Dichev (2002), we examine the extent to which the financial statement accrual for book tax expense maps into tax-related cash flows. We argue that the quality of a firm’s tax accrual is decreasing in the magnitude of estimation error associated with the accrual, and that tax accrual qualit...

Australian governments have recently moved from cash accounting to accrual accounting. In doing so they have made simultaneous use of two rival accrual accounting frameworks: AAS 31 and GFS. AAS 31 and GFS operating result measures differ significantly. To date, the AAS 31 framework has enjoyed primacy. This paper evaluates these two frameworks, and suggests that GFS is superior. Accrual accoun...

BACKGROUND Very little is known about the proportion of oncology trials that get published, the time it takes to publish them, or the reasons why oncology trials do not get published. METHODS We analyzed all clinical trials that closed to accrual at our cancer center between 2009-2013. Trials were categorized by study purpose (therapeutic vs. diagnostic), phase (pilot, phase I, II, or III), a...

BACKGROUND Subject recruitment for medical research is challenging. Slow patient accrual leads to increased costs and delays in treatment advances. Researchers need reliable tools to manage and predict the accrual rate. The previously developed Bayesian method integrates researchers' experience on former trials and data from an ongoing study, providing a reliable prediction of accrual rate for ...

Investigators need good statistical tools for the initial planning and for the ongoing monitoring of clinical trials. In particular, they need to carefully consider the accrual rate-how rapidly patients are being recruited into the clinical trial. A slow accrual decreases the likelihood that the research will provide results at the end of the trial with sufficient precision (or power) to make m...

Using data collected as part of a larger evaluation of the National Cancer Institute-funded Community Clinical Oncology Program (CCOP), this paper examines the degree to which selected community, interorganizational, and structural characteristics associated with accrual to cancer treatment protocols share equal importance in accruing patients to cancer prevention and control research protocols...

BACKGROUND Poor accrual is a significant barrier to the successful completion of oncology clinical trials; half of all phase 3 oncology trials close due to insufficient accrual. Timely access to accrual data fosters an understanding of successful trial design and can be used to inform the design of new clinical trials prospectively. Accrual statistics are available within research networks, suc...

Objective To provide brief guidance on how to design accrual monitoring activities in a clinical trial protocol. Setting Two completed clinical trials that did not achieve the planned sample size, the Cost of Strategies After Myocardial Infarction (COSTAMI) trial and the Biventricular Pacing After Cardiac Surgery (BiPACS) trial. Design A Bayesian monitoring tool, the constant accrual model,...