Patient access to investigational drugs
Today, many seriously ill cancer patients do not have satisfactory standard treatment options. Many patients wish to be enrolled in clinical phase I and early phase II trials to gain access to new investigational therapies. In the Nordic countries, however, the number of these trials are limited. It is important to ensure the access to new investigational therapies. Patient recruitment is critical to the drug development program and pharmaceutical companies often choose tertiary oncologic centres with larger patient populations for initiating such trials.
The network is designed to promote patient access to new investigational drugs and access to phase I and early phase II programs in the Nordic countries.
The network was founded in March 2011 and is based on a collaboration between Clinical Cancer Research Unit, Department of Oncology, Oslo University Hospital, Norway; The Phase I Unit, Department of Oncology, Rigshospitalet, Copenhagen, Denmark; Center for Cancer Research, Department of Oncology, Herlev Hospital, Copenhagen, Denmark; Clinical Trial Unit, Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland; Early Clinical Trial Unit, Department of Oncology, Karolinska University Hospital, Stockholm, Sweden. Clinical Trial Unit, Haukeland University Hospital, Bergen, Norway and Clinical Trial Unit, Aarhus University Hospital, Denmark attended the collaboration in 2013 and 2014.
The departments included have all been involved in drug development for many years. Thus, all departments have considerable experience and reputation for scientific and medical expertise.
In 2017 The Early Phase Clinical Trials Program, Skane University Hospital, Sweden also attended the collaboration, and Tampere University Hospital in April 2018. Clinical Trial Unit at Turku University Hospital, Finland and Unit for Experimental Cancer Therapy at Odense University Hospital, Denmark attended in November 2018. In March 2019, Oslo Myeloma Center, Norway and Uppsala University Hospital, Sweden were includet.
- To make the Nordic region more attractive for early clinical studies.
- To perform state-of-art phase I and early phase II trials in oncology and hematology, to ensure the patients access to new investigational therapies.
- To work for a bilateral agreement between the Nordic countries allowing for inclusion of patients in early clinical trial protocols across the borders.
- To promote “One point of entry” for early clinical trials and common approval for the Nordic countries.
The collaboration addresses the following:
- Standard phase I (-II) studies
- First-in-man through proof of concept programs
- Other complex studies requiring scientific expertise
Each department should have a representative from the phase I units, a representative from the Clinical Research Units (or equivalent) and a representative for the research nurses. Other relevant persons will be invited ad hoc.
The chairman and secretary are selected for two years.
Responsibilities of chairman: Call for meeting including agenda.
Responsibility of secretary: minutes from the meetings, news on the WEB.
Twice yearly. The organizer of the meetings is responsible for all practical issues.
Each member covers their own travel expenses.
Nordic NECT web-site supported by the Norwegian Cancer Society.
Nordic NECT has previosly received funding from the Nordic Cancer Union and The Norwegian Radium Hospital Foundation for a Project Manager/Secretary, 50-100% position for 3 years.
Rikke Løvendahl Eefsen MD, Ph.D
Centre of Cancer Research
DK-2730 Herlev, Denmark
Phone +45 38683868
Katriina Peltola MD, PhD
Early Phase, Clinical Trial Unit
Helsinki University Central Hospital
Haartmaninkatu 4, Helsinki
P.O. Box 180
Phone: +358 94711
Secretary and WEB master
Kirsten Thorin Hagene