THE FEASIBILITY-PROCESS IN NEXT
Companies wishing to conduct a clinical trial in the early phase can contact the coordinating unit in the relevant NEXT Center. The company’s feasibility inquiry is distributed to the clinical departments in the NEXT Center and within a working week, a joint reply is sent back to the company with an evaluation of the possible conduct of a clinical trial and an announcement from clinical departments in the NEXT Center wishing to participate in the specific clinical trial.
NEXT has developed a Confidentiality Disclosure Agreement (CDA) and a contract (Clinical trial Agreement (CTA)) which both are approved by all lawyers in the regions and by the companies LEO Pharma, Novo Nordisk, Novartis and Roche. The CDA is a declaration which is signed once by hospital management and sponsor and which is then applicable for all departments on the concerned hospital as long as NEXT will exist.
The NEXT Center offers coordination of any contact to lawyers in the regions to get assistance with the approval of CDAs, contracts etc.
In this way, NEXT has streamlined the start up process for clinical trials. The industry has one point of contact for an evaluation of the possible conduct of a particular trial in Denmark. Afterwards, it is easy to get started, since NEXT offers premade CDAs and contracts. Via the national collaboration, more patients will be offered experimental treatment with new drugs.