Beta-Blocker Heart Attack Trial (BHAT) (accessed 17 January 2017).Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial, Journal of the American Medical Association, 289, 3106-3116. Berkman LF, Blumenthal J, Burg M, et al.Modelling, prediction, and adaptive adjustment of recruitment in multicentre trials, Statistics in Medicine, 26, 4958-4975. Discussion on the paper "Real-time prediction of clinical trial enrollment and event counts: a review" by DF Heitjan, Z Ge, and GS Ying, Contemporary Clinical Trials, 46, 7-10. We illustrate this method using real data from two well-known, multicenter, phase III clinical trials. It is suitable for the modern, centralized data management environment and requires minimal effort to maintain. SPRM is a new, continuous patient recruitment monitoring tool that provides an opportunity for corrective action in a timely manner. The required extension of the recruitment period can also be derived for a given confidence level. A straightforward application of the counting process framework can be used to estimate the probability to achieve the target enrollment under the assumption that the current trend continues. The packet data approach combined with the Central Limit Theorem makes the method robust to the distribution of the recruitment entry pattern. It gives an early warning when the recruitment is unlikely to achieve the target enrollment. Based on the sequential probability ratio test using improved stopping boundaries by Woodroofe, the method allows for continuous monitoring of the rate of enrollment. We propose Sequential Patient Recruitment Monitoring (SPRM), a new monitoring procedure for patient recruitment in a clinical trial.
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