Federal Office for Safety in Health Care Institute Surveillance/Div. Clinical trials Traisengasse 5, 1200 Vienna, Austria Clinical Trials Statistics 2017 Current Statistics for Clinical Trials with Medicinal Products in Austria The year 2017 saw an all-time low in clinical trial submissions for medicinal products to the Austrian agency. Following the same structure as in previous years, the statistics will be elaborated further in the subsequent paragraphs. Of note, until 2013, multiphase trials were counted in each of the indicated phases. Since 2013 they are counted under their lower phase only (i.e. Phase I/II are counted as Phase I). This explains earlier differences between the total sum and the sum of the entries in the phase columns. Table 1: Listing according to phases Year Phase I Phase II Phase III Phase IV 2006 31 103 170 39 2007 25 104 157 68 2008 43 110 163 54 2009 41 106 128 42 2010 46 99 158 46 2011 41 107 150 46 2012 33 85 139 43 2013 31 87 145 55 2014 23 71 115 39 2015 39 70 151 45 2016 36 83 113 27 2017 20 71 118 26 The negative trend of recent years affects all phases of clinical trials although it is not equally distributed. Interestingly, there was a focused reduction of phase III and IV trials from 2015 to 2016, but a reduction of phase I trials from 2016 to 2017. Multinational trials reached their highest percentage so far with 78,6% (see table 2). The proportion of academic versus commercial trials remained constant in the historical range. On average, 60 percent of clinical trials in the EU are being conducted by commercial sponsors and the remaining 40 percent by the academic sector. In Austria, the distribution remains relatively constant at 70:30% in favor of commercial sponsors. 1 von 5
Table 2: Percent distribution of commercial, academic and multinational trials Year Count % comm % acad 2006 340 79,4 21,5 2007 349 72,8 28,7 2008 360 81,1 21,7 2009 309 69,6 33,0 2010 336 77,4 26,5 2011 327 75,2 30,0 2012 292 64,4 38,4 2013 316 69,3 30,7 2014 248 71,8 28,2 2015 305 70,8 29,2 2016 259 73,0 27,0 2017 234 70,9 29,1 Figure 1: Phase distribution in Austria (AT) since 2006 Clinical trial submissions were reduced by 9% compared to 2016. The decline of clinical trial submissions by commercial sponsors was 12% thus replicating the results of the previous observation period. Academic clinical trial submissions remained constant. Specifically, a strong reduction in commercial phase I studies (from 28 to 12) versus 2016 and a less pronounced reduction of commercial phase II studies (from 56 to 46) was observed. In contrast, academic phase I and II studies remained low but constant; the same is apparent for phase III and phase IV studies of both commercial and academic sponsors. Seven out of the 20 phase I studies were declared as First-in-Man studies by the sponsors. 2 von 5
Table 3 Clinical trial distribution according to phase and sponsor type (commercial/academic) Phase I Phase II Phase III Phase IV Year comm acad comm acad comm acad comm acad 2006 26 5 69 34 153 17 22 17 2007 20 5 76 28 135 22 23 45 2008 32 11 83 27 153 10 24 30 2009 22 19 62 44 116 12 15 27 2010 33 13 68 31 134 24 25 21 2011 31 10 71 36 129 21 15 31 2012 13 20 54 31 111 28 10 33 2013 20 12 64 23 128 17 7 46 2014 14 9 55 16 99 16 10 29 2015 23 16 46 24 137 14 10 35 2016 28 8 56 27 98 15 7 20 2017 12 8 46 25 101 17 7 18 Figure 2 and 3 illustrate the phase distribution of clinical trials submitted by commercial and academic sponsors respectively Figure 2: Clinical trials by commercial sponsors in Austria 3 von 5
Figure 3: Clinical trials by academic sponsors in Austria Further information on clinical trials in Austria and the EU can be found on the BASG website and in the EU Clinical Trials Register, which is referenced in the downloads and further information section. Considerable resources are still being invested in the optimization of the internal IT system and preparations for the practical application of the Clinical Trials Regulation. In particular, the contribution to the development and testing of the EU portal is both essential and a significant drain. In parallel, the demands for the practical translation of the Medical Device and In Vitro Diagnostics Regulations are steadily increasing. The pilot project for clinical trials according to Regulation (EU) 536/2014 was continued in 2017 and serves to develop and test practical scenarios for the National Competent Authority (BASG) Ethics Committees and applicants. The Austrian agency remains committed to the Voluntary Harmonized Procedure (VHP), the multinational clinical trials assessment pilot, both as a reporting and as a concerned member state. The National pilot project is given precedence over participation in the VHPplus, which would require the added participation of ethics committees. Current information on the VHP and generally the conduct of clinical trials is presented in the guidance document on the BASG website is regularly communicated in external presentations. The presentations given in the context of previous agency stakeholder information events ( AGES Gespräche ) can be retrieved from the archive of the AGES academy website (in German). Downloads and further information: Clinical Trials Regulation (in the EU languages) http://eur-lex.europa.eu/legal-content/en/txt/?uri=uriserv:oj.l_.2014.158.01.0001.01.eng 4 von 5
BASG Gespräch Klinische Prüfung 2018 (in German) www.ages.at/service/ages-akademie/programm-detail/kalender/detail/event/basg-gepraech-schwerpunkt-inspektionen/archiv/ EU-Register for Clinical Trials of Medicinal Products www.clinicaltrialsregister.eu/ Contact: Dr. Ilona Reischl BASG/AGES, INS/CLTR Tel.: + 43 (0) 50 555-36820 E-Mail: ilona.reischl@ages.at 5 von 5