Background According to current EU regulations, sponsors are free to decide whether or not to provide hospitals with certain medicinal products used in the context of a clinical trial (CT), but not as an investigational medicinal product (IMP); such products as background treatment, challenge agents, rescue medicines or medicinal products used to assess end-points in the CT. As a result, in some CTs, European hospitals have to pay the costs of these auxiliary medicinal products. The proposal for a new Regulation of the European Parliament and of the Council on CTs on medicinal products for human use will introduce new obligations in respect of manufacturing and labelling of auxiliary medicinal products.
Purpose To asses the number and circumstances of CTs in which sponsors have decided not to provide the hospital with the auxiliary medicinal products and how these circumstances would be affected in the event that the proposed new regulation finally comes into force.
Materials and methods Protocols and records of all CTs that started in our hospital in the period from September 2012 to September 2013, were examined to find out which auxiliary medicinal products were provided by sponsors and which were provided by the hospital.
Results 334 CTs were active at our hospital in September 2013. 102 new CTs started in the period from September 2012 to September 2013, 6 were closed before our study and 96 were examined. In 2 CTs (2%) auxiliary products were considered background treatment and were not provided by the sponsors. In 13 CTs (13.5%) auxiliary products were partially provided by sponsors; 9 of them were background treatment, 1 concomitant medicinal products and 3 CT could not be classified in any of the categories of the existing regulations. 8922 units were dispensed from January to August 2013 and 924 units (10.4%) were provided by the hospital. This percentage only includes the drugs that are prepared in the pharmacy such as monoclonal antibodies and cytotoxics, not the rescue medicines or the drugs used before the treatment to avoid adverse events. The ratio of medicines provided by sponsors to those provided by hospital was 2.3 to 1.
Conclusions Auxiliary medicinal products provided by the hospital were 10.4% of the total number of units dispensed. If the proposal for a new EU Regulation is finally passed these products should be labelled. As a result, either they would be labelled in the hospital (which would increase the workload of the hospital pharmacy), or they would be labelled and provided by the sponsors (which would reduce the costs of the hospital).
No conflict of interest.
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