Estimation of patient accrual rates in clinical trials based on routine data from hospital information systems.
BACKGROUND
Delayed patient recruitment is a common problem in clinical trials. According to the literature, only about a third of medical research studies recruit their planned number of patients within the time originally specified.


OBJECTIVE
To provide a method to estimate patient accrual rates in clinical trials based on routine data from hospital information systems (HIS).


METHODS
Based on inclusion and exclusion criteria for each trial, a specific HIS report is generated to list potential trial subjects. Because not all information relevant for assessment of patient eligibility is available as coded HIS items, a sample of this patient list is reviewed manually by study physicians. Proportions of matching and non-matching patients are analyzed with a Chi-squared test. An estimation formula for patient accrual rate is derived from this data.


RESULTS
The method is demonstrated with two datasets from cardiology and oncology. HIS reports should account for previous disease episodes and eliminate duplicate persons.


CONCLUSIONS
HIS data in combination with manual chart review can be applied to estimate patient recruitment for clinical trials.
Dugas
Martin
M
Department of Medical Informatics and Biomathematics, University of Münster, Münster, Germany. dugas@uni-muenster.de
Amler
Susanne
S
Lange
Matthias
M
Gerss
Joachim
J
Breil
Bernhard
B
Köpcke
Wolfgang
W
D002986:Clinical Trials as Topic; D006751:Hospital Information Systems; D006801:Humans; D018579:Patient Selection