The NCT Trial Center stands for competent planning and implementation of clinical-oncological studies.
NCT Trial Center
It supports clinical-oncological and epidemiological studies initiated by investigators of the German Cancer Research Center Heidelberg and the Heidelberg University Hospital. The NCT Trial Center takes over tasks of the trial sponsor and provides a wide range of services throughout all phases of clinical trials, starting with the study concept, during application and execution all the way to publication. Qualified, experienced and continuously trained personnel provide services in the fields of project management and study coordination, biostatistics, data management and information technology.
The NCT Trial Center ensures that clinical studies are planned, conducted, analyzed, and reported according to international standards and applicable laws, and supports scientifically driven explorative reuse of trial data to generate new hypnoses. It develops und utilizes quality-controlled processes and templates within an efficient infrastructure.
The NCT Trial Center operates in close cooperation with other academic research institutions on the campus, especially the Coordination Center for Clinical Trials (KKS) of the Heidelberg University Hospital, the Institute of Medical Biometry and Informatics (IMBI) of the Heidelberg University as well as the Biostatistics, Medical Informatics for Translational Oncology, Theoretical as well as Applied Bioinformatics Departments of the German Cancer Research Center (DKFZ).
The key task of the NCT Trial Center is the development and conducting of innovative clinical studies. The focus is on initiating academically motivated oncological studies with particular clinical significance, novel scientific issues, interdisciplinary character and new innovative drug substances and treatments.
Clinical studies are supported by experienced and continuously trained personnel throughout all phases, beginning with the study concept, during application and execution all the way to publication. In addition, central IT projects such as cross-linking and migration of large quantities of data, pseudonymization services and online questionnaire tools are initiated and supported. The NCT Trial Center also assists and maintains cooperation with academic trial-supporting institutions locally, nationally and internationally.
Project Management coordinates all study-related processes and all parties involved, timelines, and responsibilities starting from the idea up to the final report and publication of a study. It ensures that sponsor tasks and study topics are soundly planned and optimized according to resources, budget and timelines, and comply with the relevant regulatory standards. In the early planning phase Project Management
- provides regulatory advice and budgetary planning,
- supports the feasibility analysis of study ideas,
- assists with funding applications, and
- the drafting and negotiation of contracts.
Comprehensive quality-assured templates are available for preparing the necessary study documents for trial set-up, application with ethics committee and regulatory authorities, and trial conduct. The NCT Trial Center actively assists in the
- preparation of study documents and
- application and notification procedures for ethics committees and regulatory authorities.
After initiating the study, the Project Management monitors progress, budget adherence and reporting activities. It coordinates study logistics and serves as the central point of contact for trial centers and clinical monitors.
After the study is completed, close-out of all centers and preparation of the final study report together with Biostatistics and Data Management is taken care of.
Biostatistics provides early help in the planning and conception of clinical trials. It is responsible for statistical guidance, biometric appraisal and the statistical analysis of clinical research data obtained during the trial.
Its functions include:
- conception of clinical studies in close cooperation with internal and external partners
- guidance in the selection of study design, the target population and objectives criteria
- selection of statistical methodology and calculation of the required sample size
- conducting statistical analyses, reporting, and statistical interpretation of the results
During the planning of a study, Biostatistics is responsible for development of the statistical parts of the trial protocol, the randomization plan and the statistical analysis plan. During conduct of the study, it carries out interim statistical analyses and reports. At the end of the study it is responsible for statistical analysis, the preparation of study reports and the statistical interpretation of results. It also participates in preparing the publication.
Data Management ensures the integrity and validity of the data acquired and analyzed within the study by making use of organizational, methodological, conceptual and technical measures. It is involved in the development of the trial protocol and prepares paper-based or electronic Case Report Forms. At the beginning of the study, preparation and release of the trial database and the designing of data input masks is of particular importance.
In the further course of the study, the main functions include:
- monitoring of the entire data flow,
- creation and application of trial-specific programs for quality control of the data, and
- development of programs for processing and evaluating study data for reports, presentations, and study meetings during the trial as well as for the final study report.
As a quality assurance measure, all relevant process steps and the validation of developed computer programs are documented. Furthermore, the Data Management administers the Clinical Trial Information System (CTIS) of the NCT.
Quality assurance is an essential element of Good Clinical Practice (GCP) and therefore a central element of the NCT Trial Center. It comprises a broad spectrum of coordinated and standardized processes that are summarized in standard operating procedures (SOPs) of the NCT Trial Center. These SOPs provide a broad spectrum of working documents, templates and checklists for planning and conducting clinical studies and analyzing study data.
For new staff, a comprehensive function-specific introductionary training concept facilitates rapid and comprehensive qualification. Overall, the personal in the NCT trial center is trained and experienced in a broad spectrum of tasks leading to a high level of qualifications.
The NCT Trial Center provides information on the clinical studies of the NCT to physicians.