HOVON data center
Within the HOVON Data Center, abbreviated to HDC, all the trial logistics is organized. This comprises out of:
- Trial Management
- Central data management
The HDC has been based in Rotterdam since 1995, and is part of the Erasmus Medical Centre. The HOVON organization has entered into a collaborative agreement with this hospital, whereby HOVON is able to make use of the infrastructure and facilities of the academic center.
The activities of the HDC broadly consist of the following components:
For the HOVON trials, the submission coordinators at the HDC are responsible for all submissions in the Netherlands to the central METC (Medical Ethical Assessment Committee), KWF (Dutch Cancer Foundation) and CCMO (Central Committee for Research Involving Human Subjects). Also in Belgium and Luxembourg the submission to the competent authorities is either executed by the HDC, or supported.
Submission dossiers for ethical committees and authorities outside of the BeNeLux are prepared by the HDC in a way that the national trial coordinator only needs to translate the patient specific information and add their national obligatory documents to the dossier. The trial manager of each trial ensures that all logistics for the trial are arranged – like making sure that the trial medication distribution is organized and sampling routes and processes are set up. The trial team, consisting out of trial assistants, central data managers, monitors, statisticians, ICT and safety officers makes sure that all trial documentation like manuals are written and all databases necessary for capturing the patient data are correctly set up.
The trial managers and trial assistants are responsible for checking the obligatory site documents so that sites that wish to participate in the trial can be activated. The trial manager informs the participating hospital about the trial and assists the chief Principal Investigator in the execution of the trial. The trial manger regularly consults with the chief Principal Investigator on the timelines and targets.
Central Data Management
Numerous Dutch and foreign sites participate in HOVON trials. All these sites fill out the relevant clinical data in HOVON databases. Subsequently, the data for the patients in the trial is evaluated. If there are uncertainties or inconsistencies in the data set, queries are sent out to the sites. Once the intended patient numbers for a trial have been achieved, and all data are correct, the database is passed on to the statistician.
As well as evaluating the CRFs, the data managers are also involved in setting up specifications for the database and checks, writing instructions on how to fill out electronic Case Report Forms (eCRFs) for the site and processing details from PA Review, Cytogenetics review and Quality of Life questionnaires.
Each trial needs to be monitored. Based upon the risks of each trial, it is decided what kind of monitoring will be performed. The HDC monitors are not only involved in study specific monitoring, but also in reviewing the Dutch HOVON sites on the echelon criteria. They also act as a bridge between sites and the HDC, making sure that the requests the HDC places on the sites can be executed by the sites. The monitors also provide feedback from the sites to the trial managers so that trials remain to be organized in a way that they can be well executed.
The statistician becomes involved in each trial at an early stage. Not only do statisticians assist in designing and structuring the trials, they also produce a statistical analysis plan and set up the programming scripts for statistical processing. During the trial, the chief Principal Investigator, data manager and statistician regularly consult on the data, data collection and evaluation. The statistician is above all responsible for ensuring that the various analyses of the data set are implemented, so that based on the statistical reports, publications can be generated.
The safety desk is responsible for evaluating the patient safety data such as Serious Adverse Events (SAE), Dose Limiting Toxicities (DLT) and Adverse Events of Special Interest (AESI). They will closely cooperate with the medical reviewer to analyze if an SAE is also a Suspected Unexpected Serious Adverse Reaction (SUSAR) and report the SUSARs to the applicable bodies.
ICT is mainly involved in the set-up of data bases for each trial according to the specifications that are designed by the lead Central Data Manager. This not only consists out of developing CRFs, but also creating automated checks that check the data consistency, and set up the notification system so that all local parties are informed about the enrollment of new patients or other events that are generated in the system and need certain action(s) to be performed by the site. Next to setting up trial specific operations, ICT is also involved in the set up and maintenance of systems like the Trial Management System, that supports the trial team and provides insight in the trial execution.
If you have any questions on the operations of trials, you can find the trial manager mentioned in the trial section. If you have any general questions on trials, please contact us by:
Telephone: +31 (0)10 704 1560