DANISH PAIN TRIAL CENTER
The Danish Pain Trial Center is a unique, nationally coordinated initiative and the only center world-wide with an entire country providing its expertise within a specific medical field to develop better and more efficient drugs.
Chronic pain affects approximately 20% of the adult population and there is a massive unmet need for efficient and safe drugs for pain management.
It is well-known that the pain area is specifically challenging for the pharmaceutical industry as many drugs have failed in the past. One reason is the poor translation of pre-clinical data into patients. A way to increase the success rate is to utilize a mechanism-based screening and profiling approach and to offer facilities representing the most advanced and updated solutions in the field.
The Danish Pain Trial Center performs single or multi-center clinical pain trials from Phase I first-in-man to Phase III. The center offers a well-organized infrastructure of pain laboratories and clinics from all regions in Denmark all with a long history of performing clinical trials in pain. We ensure efficient recruitment of pain patients in most relevant fields of chronic pain and gather internationally recognized pain researchers and clinicians. The center provides state-of-the-art mechanism-based technologies for pain assessment, and the highly professional and competent staff complying with all aspects of GCP.Moreover, the center has established harmonization of all pain assessment procedures between the partners according to standard operational procedures and is endorsed by 16 pharmaceutical companies within the area.
SCOPE OF THE CENTER
The purpose of The Pain Trial Center is to help the pharmaceutical industry and at the same time highlight Denmark as the most attractive choice for early clinical trials of analgesics; the main priorities of The Danish pain Trial Center being national recruitment of patients in various pain categories and innovation related to patient and drug profiling.
CLINICAL TRIALS IN DENMARK
Over the last decade, Danish pain researchers have provided new insight into the areas on which The Pain Trial Center is based. Denmark has a leading international position within development and application of pain biomarkers: no other country offers the unique research-based national infrastructure to support early clinical trials of analgesics.
Denmark has a very well-organized register in which all patients are registered with specific disease codes and current/past medication. Searching for patients with specific diseases ensures fast and efficient options for recruiting. The clinical partners of the center are in daily contact with many selected pain patient populations.
The Danish Pain Trial Center comprises a national network of basic and clinical research groups from all five regions of Denmark with a physical anchor-point at Aalborg University.
Chronic pain represents a major societal burden with approx. 1 million lost workdays per year in Denmark alone corresponding to an economical loss of EUR 1 billion. Globally, this challenge is addressed by approx. 150 pharmaceutical companies who develop novel analgesics to the steadily expanding analgesics market of EUR 50 billion in 2014.
Denmark has a strong position in early clinical trials in pain management as evidenced by the fact that 5% of the registered global clinical trials are carried out in Denmark. The combination of scientific excellence and a proactive Danish regulatory body has made Denmark a key global player within development and implementation of innovative methods for (1) prediction of the individual's vulnerability to develop chronic pain; and (2) biomarker profiling of patients with chronic pain.
The purpose of The Pain Trial Center is to help the pharmaceutical industry and at the same time highlight Denmark as the most attractive choice for early clinical trials of analgesics; the main priorities of The Danish pain Trial Center being national recruitment of patients in various pain categories and innovation related to patient and drug profiling. Read more
STAFF & FACILITIES
Qualified Staff: The center provides access to GCP qualified staff, including monitors, project managers, statisticians, researchers, and clinicians.
Facilities and Laboratories: The center has access to fully equipped and highly specialized experimental and clinical pain laboratories dedicated to experimental and clinical pain trials. Specific pain assessment procedures are harmonized between units and common standard operational procedures have been developed.
THE CENTER OFFERS
Phase la studies:
Phase lb studies:
Human experimental proof-of-concept studies in healthy subjects
Phase lb & la studies:
Clinical proof-of-concept studies in selected groups of patients with chronic or episodic pain conditions
Phase lll studies:
Single or multi-center