COMBACTE’s Tailored Network Management System
COMBACTE uses its European wide network of over 1000 hospitals and 800 laboratories to efficiently select suitable sites for clinical trials. An accurate and tailored database system is essential to keep track of COMBACTE’s network, study start-up and progress. Since 2013, COMBACTE conducted and supported 37 site selections and clinical trials with a network that has grown to include 1,052 hospitals and 853 laboratories across 42 countries in Europe.
Maintaining a network capable of conducting high-quality clinical research requires a robust database and tracking system. This provides an accurate and updated overview of all organizations and contacts part of this continuously growing network.
NETWORK MANAGEMENT SYSTEM
The Network Management System (NMS) was developed to handle the large amount of data gathered from hospitals and laboratories in the COMBACTE network. This covers characteristics of hospitals, laboratories, and contact details. NMS currently counts over 4,700 hospital and laboratory contacts. The system keeps track of the various relations between networks, countries, regions and organizations as well as trial participation.
FEASIBILITY PROCESS
The NMS facilitates COMBACTE’s study start-up and feasibility process. Its Feasibility Questionnaire module allows the CLIN-Net and LAB-Net teams to easily configure, format and send out feasibility questionnaires from the system directly to COMBACTE contacts.
A clear overview of all sent invitations and the status of questionnaire completion is kept. Over 7,000 feasibility questionnaires were sent out to the network for the various studies COMBACTE supports. 3,902 different variables within the various questionnaires deliver vast amounts of information that inform site selections for new trials.
NMS is closely integrated with the GCP-compliant Electronic Data Capture system Research Online. It automatically prefills feasibility questionnaires with all available information on a hospital, laboratory or contact through previously completed questionnaires. The prefilled answers can be corrected as needed, so a site or contact’s most recent information is stored and updated.
The outcomes of the site selection and study start-up process are also registered; from sites selected for participation, to back-up sites, or not selected sites. This way, NMS keeps track of the entire feasibility process.
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“By knowing in detail how an individual site can perform we are able to act quickly when a trial request reaches us. We can transparently select the sites that are the best fit for several clinical trials simultaneously for a wide range of indications in the field of infectious diseases.”
Miranda Hopman, CLIN-Net Sr. Project Manager
MEASURING PERFORMANCE
Another important NMS feature is the storing of performance and qualitative data on sites and contacts. This provides additional insight into the network and allows further quality improvement of future site selections. The NMS can register information on a site’s performance in a study (e.g. recruitment numbers or ethical approval timelines). Besides quantitative data, qualitative information about sites and contacts is registered. This helps identify best performing sites, or any challenges within organizations or countries.
In the last few years, COMBACTE worked on analysing (the development of) the network and identifying the best performing clinical sites. Site performance evaluation was done by checking site capabilities and previous study performances, next to other quantitative and qualitative data.
The NMS is a crucial source of information for this analysis and serves as a database of each site’s capacity. It is a vital asset for the efficient start-up of (non-) COMBACTE clinical trials.
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