AB0614 The lupus studies: the european and spanish point of view
Authors: N. Bahamontes-Rosa, A. Muñoz Jiménez, F.J. Hidalgo, M.V. Pardo, J.I. Diago Cabezudo
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Improving systemic lupus erythematosus patient care comes from the advances performed first in basic science that improved our understanding of the mechanism underlying the pathogenesis and finding effective and safe medications that led to treatment improvement. Furthermore, clinical trials play a key role in advancing both our medical knowledge of the disease and novel treatments. <h3>Objectives</h3> This work aims to offer an overview of the type and characteristics of lupus studies and to analyse the contribution that Europe and Spain have made in supporting those investigations. <h3>Methods</h3> A systematic review of the public registry database of publicly and privately supported clinical studies (CS), ClinicalTrials.gov, was done considering "lupus" as a search criteria (database generated with all CS registered on the 19th September 2017). Data collected included: CT code, title, sponsor, countries participating, study phase, condition and intervention. <h3>Results</h3> <i>Study distribution.</i> By 19th September 2017 there were a total of 256127 CS registered in the world, from which 611 (0.24%) are associated with lupus studies. From those, 27.2% are carried out in Europe. Spain is the third country in Europe in number of lupus CS after France and Germany. <i>Type and distribution of the studies.</i> In the generated clinicaltrials.gov data base, the studies are associated to a type of study. The distribution varies depending on the geographical area. In general, the main type of lupus studies conducted in the world are related to the discovery and development of new treatments (n=406) but there are also behavioural, devices investigation, diagnostic test, dietary supplementation, genetic and radiation studies. In Spain, 94.6% of the studies registered are related to new treatment development. The distribution of the lupus studies are as follows: <i>Financial support.</i> 58.6% of all studies are funded by sources other than industry and 34.8% are supported by it. In a detailed analysis, 12.5% of the studies are under the economic support of the National Institutes of Health (NIH) or the partnership of NIH+other partners. The scenario is different in Europe where industry supported 54.8% of the studies and in Spain where industry supported 87.3% of the studies. Moreover, the funding profile in Spain showed that 92.3% of the studies associated with new treatments are supported by industry and 7.7% of them are supported by other sources. On the other hand, 100% of the studies not related with new treatments development are supported by funding source other than industry. <h3>Conclusions</h3> Europe participate in more than a quarter of Lupus clinical studies and Spain is the third European country participating in those clinical studies. New treatment development studies are the main CT performed worldwide and the percentage is even higher in Spain. Regarding the study phase, the distribution of CT in Europe and Spain are similar although phase I studies in Spain are less frequent. From all studies registered, the majority are non-industry sponsored studies. In Europe and in Spain the situation is the opposite, as 87.3% of the studies are pharma-sponsored studies. <h3>Disclosure of Interest</h3> N. Bahamontes-Rosa Shareholder of: GSK, Madrid, Spain, Employee of: GSK, Madrid, Spain, A. Muñoz Jiménez Employee of: Hospital Virgen del Rocio, F. Hidalgo Shareholder of: GSK, Madrid, Spain, Employee of: GSK, Madrid, Spain, M. Pardo Shareholder of: GSK, Madrid, Spain, Employee of: GSK, Madrid, Spain, J. Diago Cabezudo Shareholder of: GSK, Madrid, Spain, Employee of: GSK, Madrid, Spain