KIS-based support of patient recruitment in clinical trials (BMBF KIS Rek)

Every new medical therapy, may it be a drug or a surgical technique, has to be evaluated. Clinical trials are currently the gold standard for the evaluation of medical innovations. Within clinical trials, the benefit and potential harms, in comparison to existing therapies, are tested. Scientific methods, such as blinding, comparison between placebo and treatment group and analysis of statistical significance ensure well-tested results. As each of these clinical trials relates to another type of patient and disease, the participating cohort has to be defined and recruited with every new trial.

Currently, the process of patient recruitment, based on a trial’s eligibility criteria, is a manual task: patient records are examined, medical staff has to be asked for potentially eligible patients and treating physicians have to have a trial in mind. This may lead to unnecessary, repetitive work while probably missing potentially eligible patients in different wards of the same hospital. Hence, clinical trials are at risk of experiencing an extension, which leads to additional cost. Reviews have shown that one third of clinical trials even have to be canceled because the patient recruitment was not successful within the estimated time [1].

First projects show that the patient recruitment can be supported electronically by using patient data from routine documentation. Study assistants may be notified automatically, a manual search can be replaced and the number of recruitments may increase [2]. However, these solutions are always designed for local Hospital Information Systems (HIS). A generalized or portable implementation has not been developed yet.

To address this issue, the University Hospitals of Münster, Düsseldorf, Erlangen, Heidelberg and Gießen, each of these using another HIS, came together with the TMF e.V. The goal of this project is the development of a generic solution, its implementation and evaluation.

The project ran from May 1st 2010 to December 31th 2012 and was sponsored by the Federal Ministry of Education and Research (BMBF).

For further information please visit the websites of TMF well as the Chair of Medical Informatics in Erlangen or watch our KIS-film (german language only).

After completion of the project the developed system was continued at the university hospital Münster, so that up till today more than 80 studies were supported or still are at the UKM.


Credentials:[1]      McDonald A, Knight R, Campbell M, Entwistle V, Grant A, Cook J, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials 2006;7. URL:

[2]      Dugas M, Lange M, Berdel W, Muller-Tidow C. Workflow to improve patient recruitment for clinical trials within hospital information systems - a case-study. Trials 2008;9:2.


Project publications:

    Köpcke, F., Trinczek, B., Majeed, R. W., et al. (2013). Evaluation of data completeness in the electronic health record for the purpose of patient recruitment into clinical trials: a retrospective analysis of element presence. [Research Support, Non-U.S. Gov't]. BMC Med Inform Decis Mak, 13, 37. doi: 10.1186/1472-6947-13-37

     Trinczek, B., Köpcke, F., Leusch, T., et al. (2014). Design and multicentric Implementation of a generic Software Architecture for Patient Recruitment Systems re-using existing HIS tools and Routine Patient Data. Applied Clinical Informatics, 5(1), 264-283. doi: 10.4338/ACI-2013-07-RA-004
    Schreiweis B, Trinczek B, Köpcke F. et al (2014). Comparison of electronic health record system functionalities to support the patient recruitment process in clinical trials. Int J Med Inform.;83(11):860-8. doi: 10.1016/j.ijmedinf.2014.08.005