The Study Center
In its role as international study reference center and sponsor the LCH-study team is collaborating with the international study committee responsible for the design and conduct of the study and the dissemination of the final results. In addition to scientific and medical expertise, specialized knowledge in the methodological, administrative, technical, and regulatory background of clinical trials is required.
Major tasks need to be performed at any stage of a clinical trial:
- Prior to the initiation of a study
consensus on aims, end-points and study design; protocol-writing; design of the case report forms; approval from regulatory authorities and ethic committees, contracts with participating national groups and study sites
- During an on-going study
data collection and data quality control, pharmacovigilance, design and implementation of amendments, reporting of interim results, advising clinicians on critical diagnostic or therapeutic questions, organization of national and international meetings
- After closure study
data analysis, coordinating drafting and submission of the manuscript with the final results.
As the current LCH IV study has been started on the background of a web based database, all issues concerning this database have to be monitored and possible adjustments have to be made.
Management tasks include supervision of personal agendas, financial management, organization of national and international working group meetings as well as communication with patients and parents initiatives.
Another very important function of our center is to advise clinicians on critical diagnostic or therapeutic questions. We receive about 250-300 inquiries per year concerning difficult LCH scenarios. About 50% of these require a review of radiological images to adequately assess the individual cases.