Changing landscape of clinical cancer trials in Germany

Abstract

Abstract Background The development of new therapeutic options for cancer patients due to a better understanding of tumor biology has profound effects on the design and conduct of modern clinical cancer research especially with respect to clinical trial design. Until recently, cancer drugs have been investigated in clinical trials for a definitive histological tumor type but this approach is slowly changing and recently drugs have been approved rather histology agnostic based on genomic alterations in various histological tumor types. Here we investigated the changes in the landscape of clinical cancer trials in Germany from 2000-2016. Methods Clinical trials gov database was queried in 2017 for interventional clinical cancer trials running in Germany with study start between 01/01/2000 and 31/12/2016. Data extracted from the database included the conditions, interventions, study phase, Sponsor/Collaborators, funder type, study design, outcome measures and number enrolled. Results Overall, 2977 trials matching the criteria were extracted. Number of studies heavily increased within the first decade from 32 studies in 2000 to 214 studies in 2010, remained thereafter relatively stable (with 260 in 2011, 243 in 2012, 236 in 2013, 252 in 2014, 274 in 2015 to 224 in 2016). There was a clear change in the study design over the years towards more trials with a placebo. Furthermore, the number of entities investigated within one clinical trial (from 1 tumor entity, 2-5 tumor entities, 6-10 tumor entities and >10 tumor entities (including clinical trials targeting events from various entities) increased over the years. With respect to sponsorship, there was an increase of industry-alone sponsorship over the years. Table: 1638PD . 2000 - 2004 2005 - 2009 2010 - 2014 2015 - 2016 Masking open label 78% 75% 73% 77% single blind 1% 3% 3% 4% double blind 12% 20% 18% 12% quadruple 1% 2% 6% 6% Missing 9% 0% 0% 1% Placebo Placebo - no 95% 82% 80% 85% Placebo - yes 5% 18% 20% 15% Number of entities 1 88% 91% 89% 85% 2 - 5 6% 3% 4% 5% 6 - 10 0% 0% 0% 1% > 10 6% 5% 7% 10% Sponsorship Industrie alone 43% 68% 65% 64% other 57% 32% 35% 36% Conclusions Cancer clinical trials have changed with respect to trial design and sponsorship during the last decade to cope with recent development of new cancer therapeutics. Legal entity responsible for the study Charite Universitatsmedizin Berlin. Funding Has not received any funding. Disclosure T. Fureder: Honoraria (self), Honoraria (institution), Research grant / Funding (institution): Norvartis; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Merck Darmstadt; Honoraria (self), Honoraria (institution), Research grant / Funding (institution): AstraZeneca; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Honoraria (institution), Research grant / Funding (institution): Sanofi; Honoraria (self), Honoraria (institution), Research grant / Funding (institution): Accord; Honoraria (institution), Research grant / Funding (institution): Celegene; Honoraria (institution), Research grant / Funding (institution): Ipsen; Honoraria (institution), Research grant / Funding (institution): Astellas; Non-remunerated activity/ies: President elect Austrian Head and Neck cancer society; Full / Part-time employment: Medical University of Vienna; Honoraria (institution): Johnson and Johnson ; Research grant / Funding (institution): Amgen. U. Keilholz: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Advisory / Consultancy: Serono; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD Oncology; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Pfizer; Honoraria (self), Speaker Bureau / Expert testimony: Novartis; Honoraria (self), Speaker Bureau / Expert testimony: Glycotope GmbH. All other authors have declared no conflicts of interest.