Based upon advice from this panel, the National Board of Health may subsequently approve public expense financed experimental treatment abroad or in dedicated units of experimental cancer therapy in Denmark.
As a consequence, a national coordinating board for experimental cancer therapy has been established in order to provide therapeutic options for patients to whom no standard therapy exists.
Our Phase I unit has been established with governmental co-financing within this programme. This ensures that patients from all over the country can be referred to clinical trials, including Phase I trials with no costs incurred on the referring hospital.
The Phase I unit is integrated in the clinical research department (CRU).
CLINICAL RESEARCH UNIT (CRU)
Expertise in clinical trials
- Preparation of protocols and case record forms
- Approval from the local authorities
- Identification of investigators
- Trial monitoring
- Data processing and development of databases
- Clinical reports
- Integrated clinical/statistical reports
- Translation of protocols, patient information etc. into Danish
- Electronic ordering of antineoplastic drugs and electronic access to all protocol related material
Preparation of protocols and case record forms
Around 80 clinical studies are active at the department. Two thirds of the studies are performed in collaboration with the pharmaceutical industry or together with European research organisations (EORTC and MRC), one third of the studies are investigator initiated studies.
In case of investigator sponsored protocols, CRU prepares:
- Protocol together with investigator
- Case report forms
- Signature log
- Correspondence with legal authorities
- Contracts with departments of pharmacy, radiology, clinical chemistry and clinical physiology
- Information to the patient concerning the clinical study and informed consent
- Information concerning the medicine
- Contract with the GCP-unit in the Copenhagen area
- SAE and SUSAR reports
- Clinical study report
Approval from the local authorities
CRU gets approval from:
- Ethical committee
- Danish Medicines Agency
- The Danish Data Protection Agency
Handling time for Clinical Trials Applications in Denmark
The figure shows that the Danish Authorities have handling times well below the European limit of 60 days (comparable to 45 working days).
Study applications are handled simultaneously in DKMA, the Institutional Review Board and ethical committees. The total handling time is therefore under 45 days.
Identification of investigators
Specialists in all areas of oncology are employed at the Department of Oncology, Rigshospitalet.
Most of the project nurses in the CRU are examined monitors. CRU collaborates with the GCP unit for the Copenhagen area www.gcp-enhed.dk
Data processing and development of databases
CRU's Data Management department offers consultancy services in connection with retrieval and processing of trial data.
Database programming is performed including data entry front-end on pc-based systems
- 32-bit database application programming
- Data entry front-end design and programming
- Generation of randomization lists
- Double data entry
- Discrepancy analysis of raw data
- "Clean File" declaration when the CRFs, the database, and the reference values are complete and logical according to the study protocol, general guidelines, and data entry instructions
- Full database source documentation
- Electronic data capture
- Database query programming and export
- Digital data and file transmission (point to point or via internet)
Presentation of data as tables or graphs on paper or overhead film.