Clinical Trials on Behalf of Industry – New Procedure at OUS
Oslo University Hospital (OUS) has implemented a new procedure to ensure good routines and efficient use of resources when it comes to inquiries from the industry about participation in clinical trials.
Clinical trials performed on behalf of the pharmaceutical or medical equipment industry is an important task for the hospital and a significant contribution to the development of the best possible treatment for our patients. Therefore, it is important that requests from the industry for participation in such trials reach the correct recipient in the hospital, and that all requests are assessed and answered as soon as possible and always within given deadlines.
The Procedure
The eHåndbok document Kliniske studier på oppdrag for industri - prosess og forankring (Clinical trials on behalf of industry - process and anchoring) describes responsibility and procedure for answering inquiries (feasibility), formalization, involvement of service departments and financial follow-up in clinical trials with an external sponsor, where agreements and finances are handled by Inven2.
NorTrials - a partnership between the regional health authorities and the pharmaceutical and medical equipment industries - was established on assignment from the Ministry of Health and Care Services and is funded from the central government budget. The purpose is to give Norwegian patients increased access to new treatment methods through clinical trials. The assignment makes it even more important to have good routines internally in the hospitals to facilitate clinical trials with industry sponsor.
Always Respond to Feasibility Requests
During a busy working day, one can easily forget to answer a feasibility request for a clinical trial. There may be many reasons why a trial is not possible to conduct at a given time, e.g. lack of resources or competing trials on the same patient group. The inquiry may even have been sent to the wrong person or department, since it is not always as easy to find out who the right recipient is. Whatever the reason, it is important to give feedback, because lack of response gives a bad impression, not necessarily only of the department that has not responded to the inquiry, but of the entire hospital. This in turn can affect the opportunity to participate in other trials from the same company in the future. Furthermore, it is useful for companies to know the reason for the rejection. Is it due to a lack of resources in the department, or is the trial not suitable for Norwegian conditions? Perhaps the trial can still be feasible if you enter into a dialogue with the industry sponsor.
Research support at OUS is responsible for keeping track of contacts for industry sponsored clinical trials at the hospital. Feel free to contact us at kliniske.oppdragsstudier@ous-hf.no.
Link:
More information from the OUS Research Support home page www.forskerstotte.no:
Industry sponsored trials and cooperation