More than 700 patients are referred to The Phase 1 Unit each year from all regions of Denmark including The Faroe Islands, Greenland and Abroad. We have approximately 60 ongoing clinical trials and 40% of these are first-in-human clinical trials.
About the Phase 1 Unit
The Phase 1 Unit was established in 2005 as a dedicated unit for phase I and early phase II oncology clinical trials and since 2014 also for early phase hematology trials. The Phase 1 Unit is part of Department of Oncology and Department of Hematology at Rigshospitalet (Copenhagen University Hospital).
The Phase 1 Unit offer complete project management and clinical trial management systems for phase I and early phase II trials. We are operating with ICH GCP to industry standards, including standard operating procedures (SOPs) covering all aspects of running clinical trials. We comply with all current legal requirements and the EU Directive on Clinical Trials (Directive 2001/20/EC) and by January 31st, 2022 The Clinical trials Regulation EU No 536/2014. We are part of a network of leading scientists and oncologists, including collaboration with other Phase 1 units in Europe and the US.
Facilities
The Phase 1 Unit treatment facilities are manned 24 hours/day with +10 beds and an outpatient clinic located on-site at Rigshopsitalet, Denmark’s largest and most specialized hospital. The facility rapid access to all relevant specialties including ICU and radiology. On-site laboratory facilities allow for rapid, bedside processing of biological samples.
The Phase 1 Unit personnel and collaborators are fully GCP-compliant and have extensive experience in conducting complex clinical trials, including multiple PK/PD-sampling, serial tumor biopsies, and management of immune system mediated toxicity including cytokine release syndrome.
Capabilities
Patient referral
More than 700 patients are referred to The Phase 1 Unit each year from all regions of Denmark including The Faroe Islands, Greenland and Abroad.
We cannot, due to legal and logistic causes, reply to inquires from patients or relatives. We recommend that patient inquiries regarding clinical trials are directed to their treating oncologist.
The Clinical Research Unit
The Clinical Research Unit (CRU) coordinates all clinical trials from start to closure, and ensure quality according to ICH-GCP, GDPR and local country legislation. CRU consists of research nurses, lab research assistants, research secretaries and research assistants handling contracts, budgets, and finance (CRU Secretariat).
An internal review board (IRB) oversees all incoming protocols with turnaround time 14 days.
The CRU Secretariat will review the legal contracts and forward them to the Legal Department of the Capital Region for legal review and approval. Please note that pre-approved templates are preferred, as these can be approved within a few days. Other contracts may have longer approval timelines. Pre-approved contract templates can be found at www.trialnation.dk
Please note that contract negotiations are done in parallel with clinical trial application in CTIS.
Genomic Medicine
The Department of Genomic Medicine provides whole genome sequencing (WGS), RNA sequencing, SNP-arrays, large commercial NGS panel and whole exome germline sequencing for all patients referred to the Phase 1 Unit and for patients with relapsed or refractory lymphoid malignancies.
More than 600 WGS profiles including bio-informatics are processed yearly for the Department of Oncology and the Department of Haematology. The extensive molecular profiling allows for identification of patients with specific molecular alterations, including germline alterations, for precision medicine trials.
Intensive Care Unit
The ICU is located on site, in the same building as the Phase 1 Unit and with a 2-3 minutes transfer time. The majority of adverse events, including cytokine release syndrome, are treated in the Phase 1 Unit’s own ward.
The Phase 1 Unit and ICU have a long-standing cooperation and extensive experience in observation and treatment of critically ill cancer patients including the treatment of severe cases of cytokine release syndrome as well as other immune related or hyperinflammatory conditions.
Regulatory authorities / Ethics Committee and Institutional Review Board
All clinical trials are subject to approval at CTIS. Oncologic and haematologic phase1 protocols receive fast track priority with turnaround time for new submissions usually less than 40 days.
Institutional scientific review boards are embedded within the Department of Oncology and the Department of Haematology, with a turnaround time of 14 days.