Universität Bonn
Medizinische Fakultät
Epileptologie

Kontakt
Anreise
Klinikportrait
Klinikinformationen

Epilepsie

Forschung
SFB/TR 3
Lehre

Mitarbeiter/-innen
Offene Stellen
Probanden gesucht

Dekade 2000-2010

Presse

Spenden
 

Co-Investigator Judith M. Hoffmann, M.D. Tel.: +49 228 287 6193 Email: Judith.hoffmann@ukb.uni-bonn.de	Co-Investigator Michael Rademacher, M.D. Tel.: +49 228 287 6295 Email: michael.rademacher@ukb.uni-bonn.de

• Our site has experience with industry sponsored research in epilepsy patients with treatment-resistant focal epilepsy.
• We also conduct studies in the early phase of the disease (Phase I, Phase II, III and Phase IV Studies)
• During the past 5 years we performed more than 10 clinical studies.
• Our staff received special training in ICH GCP and regulatory requirements to conduct clinical trials.
• Two full time study physicians are at disposal for any new trial as well as 3 part time study coordinators/study nurses.

• We have around 6,000 patient contacts in our department of Epileptology per year. A majority is pharmacoresistant.
• Around 20% are treated with 1 AED, 20 % with 2 AEDs, 30 % with 3 AEDs and 30% with more than 3 AEDs. Around 250 Patients are implanted with a Vagus Nerve Stimulator (VNS).
• We have different recruiting tools, register potential study patients in an electronic database and are able to review and select according to different aspects (inclusion/exclusion criteria) in the different studies.
• Furthermore we have access to all patient records so that online recruitment always adds our screening list. We pre-screen patients for clinical trials using special forms and inform about the future project so that a waiting list exists.
• In the past we were able to enroll 4 to 15 patients per month depending on inclusion/exclusion criteria in different studies.
• The screening failure rate in trials is 25% (av). The drop out rate during double blind phases is around 10 to 30%.
• Retaining patients for open label studies is usually not difficult provided that patients had benefit of the trial medication.
• In general patients ask for transportation reimbursement.
• The successful recruitment of patients moreover depends on the medical/epileptologic interest of the new trial.

• For more than one year we have been able to maintain electronic medical records as source data as well as the original hand written patient records (double documentation).
• A printout of the relevant medical records is available, signed and dated by authorized persons.
• The electronic medical records are secure by unique passwords and users. One full time computer administrator is responsible for service, maintainance and repairs.

• Our site is able to complete the visit forms and ship them to the sponsor using a courier within 1 day after the patients visit.(Exept weekends)
• We are able to answer queries generated by the sponsor and fax them directly back to the sponsor.

• Our centre has a local ethic commitee. The EC is independent and constituted per ICH requirements and meets twice a month and needs 1 week to decide and answer to the application forms
• The EC approval process takes around 3 weeks. All clinical trials in our site are permitted by our local EC.
• The local health authority is always informed about clinical trials.
• An inspection of Health Authority is possible at any time in our site.
• Audits from FDA and inspections from different sponsors proceeded within the last years. There is no regulatory or professional restriction on our clinical research practice.

• Usually 2-3 weeks are required from initial submission of budget and contract to final approval and signatures.
• The Contract is made with the principal investigator, Prof. Dr. C.E. Elger, and approved by the legal department of the university clinic of Bonn.
• The approval process can be initiated parallel to the EC approval.
• The time lack between approval by EC and date of enrollment of the first patient is short, usually not longer than 1-2 weeks.

Frau Göbel	Frau Giesecke	Frau Schaffraneck