The Clinical Trial Center at NCT Heidelberg (NCT HD CTC) supports the efficient planning, initiation, conduct, and reporting of investigator-initiated clinical trials (IITs) – particularly early clinical trials of phase I to II at NCT Heidelberg and in collaboration with other NCT sites as well as additional partners.

As a core facility for clinical trial operations and structured data collection, the NCT HD CTC provides the following services for Investigator-Initiated Trials (IITs):

• Initiation of IITs by NCT Heidelberg, providing a powerful framework covering infrastructure and support for local investigators from study idea to final publication

• Trial site for IITs initiated by other NCT sites 

• Trial site for IITs initiated by academia other than the NCT sites

Clinical trial activities at the NCT HD CTC are centrally coordinated by the Clinical Trial Boards. Administrative and operational support is provided by the NCT HD CTC team, which serves as the primary point of entry for all trial‑related inquiries from NCT Heidelberg investigators, study teams, internal stakeholders, academic partners, CROs, and industry. 

• Trial Concept Board 

  The Trial Concept Board is a multidisciplinary board regrouping oncological study teams, patient representatives, and representatives of local trial-enabling units with strong expertise in various fields such as biometry, pharmacy, imaging, regulatory affairs, data/project/quality management, pathology, biobanking, pharmacovigilance, patient-reported outcome measures (PROMs), budget etc. The Trial Concept Board offers a comprehensive support to NCT Heidelberg-investigators by providing guidance at early stage to refine IIT study ideas/concepts prior to submission for funding applications – especially for the Overarching Clinical Translational Trial (OCT²) program.

• Trial Feasibility Board 

  The Trial Feasibility Board brings together study teams (PIs, sub-investigators, study nurses, study coordinators, etc.) to evaluated external study requests with focus on medical needs, operational feasibility, resource requirements, and alignment with site’s capabilities and current study portfolio. 

The activities of the Clinical Trial Boards follow a structured process outlined in the workflows below.

Are you a local investigator interested in presenting a study concept at the interdisciplinary Trial Concept Board? Our Clinical Trial Portal team is your primary point of contact and will support you in preparing and coordinating your study presentation. 

See the current workflow here (https://hub.dkfz.de/s/67r2Weiw53MeEa6) 

Email: nct-trialconceptboard(at)nct-heidelberg.de

Link to NCT IIT Portfolio

We welcome external academic and industry partners to join us in advancing innovative cancer research. If you are interested in initiating an oncology clinical trial at the CTC of the NCT Heidelberg please reach out via NCT HD CTC or the specific contact persons of the respective cancer entities listed here. 

Link to TFB-Workflow.

Email: Studienportal.NCT(at)med.uni-heidelberg.de 

Patient involvement is a core component in the development and implementation of clinical trials at NCT Heidelberg. Through their participation in the study design setup and the Trial Concept Board, patient representatives contribute to trial design from the earliest stages. This supports the development of clinical trials that are relevant, clearly structured, and feasible from the patients’ perspective. Our NCT HD CTC team works closely with the Patient Research Council at NCT Heidelberg to ensure early patient involvement in all aspects of clinical studies development at our site.

Clinical research at NCT HD CTC is guided by the principles of Good Clinical Practice (GCP). Our study teams receive regular, targeted training on GCP-related topics, regulatory frameworks, and site-specific SOPs. Trainings of the Clinical Trial Curriculum are open to medical and non-medical study staff, as well as other interested staff from NCT Heidelberg and its supporting institutions.

Would you like to join the Clinical Trial Curriculum? Email us at: ncttrialcurriculum(at)nct-heidelberg.de

Additional training opportunities are available through our partner institutions.