Clinical Trials Statistics 2017

Transkript

1 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 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 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

2 Table 2: Percent distribution of commercial, academic and multinational trials Year Count % comm % acad ,4 21, ,8 28, ,1 21, ,6 33, ,4 26, ,2 30, ,4 38, ,3 30, ,8 28, ,8 29, ,0 27, ,9 29,1 Figure 1: Phase distribution in Austria (AT) since 2006 Clinical trial submissions were reduced by 9% compared to 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

3 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 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

4 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) 4 von 5

5 BASG Gespräch Klinische Prüfung 2018 (in German) EU-Register for Clinical Trials of Medicinal Products Contact: Dr. Ilona Reischl BASG/AGES, INS/CLTR Tel.: + 43 (0) ilona.reischl@ages.at 5 von 5