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On 10 April 2018, the FAMHP launched a call for applications for the e-PIL pilot project, namely the project concerning the electronic Patient Information Leaflet. The effectiveness of the pilot project, or, in other words, the outcome of providing patient information in an electronic leaflet, will be studied using online surveys. The surveys will take place at the project’s launch, after 1 year, and after 2 years.

During its meeting of July 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of the cancer medicine Xofigo (radium-223 dichloride) to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments.

The results for 2017 confirm the trends of previous years with a reduced use of -7.4% mg active substance/kg biomass compared to last year. This is the biggest annual drop since 2011. Compared to the reference year 2011 it represents a total decrease of -25.9%.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified medicinal product AG019 from the company Intrexon T1D Partners, LLC (IT1D). The purpose of this trial is to evaluate the safety, tolerability and potential activity of AG019, alone or in combination with teplizumab, for the treatment of diabetes mellitus type 1. The public consultation runs from 25 June 2018 to 25 July 2018 inclusive.

De FOD VVVL en het FAGG nodigen u uit om deel te nemen aan de publieksraadpleging over een klinische proef met het genetisch gewijzigde geneesmiddel AG013 van de firma Oragenics. De proef dient om de veiligheid en werkzaamheid te beoordelen van AG013 voor de onderdrukking van orale mucositis bij patiënten met kanker van het hoofd en de hals die gelijktijdig radio- en chemotherapie krijgen. De publieksraadpleging loopt van 18 juni 2018 tot en met 18 juli 2018.

Last updated on 29/06/2017