Duitse organisaties trekken aan bel: “Enorme functionele problemen CTIS vormen bedreiging voor farmaceutisch onderzoek”

In een gezamelijk persbericht van Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e.V. (AKEK), Bundesverband der Arzneimittel-Hersteller (BAH), Bundesverband Medizinischer Auftragsinstitute (BVMA), Bundesverband der Pharmazeutischen Industrie e.V. (BPI), Deutsche Hochschulmedizin (DHM), Netzwerk der Koordinierungszentren für Klinische Studien (KKS-Netzwerk), Verband der forschenden Pharma-Unternehmen (vfa), dat op 28 november 2022 is gepubliceerd, wordt een oproep gedaan om de overgangsperiode, die 31 januari 2023 eindigt, te verlengen totdat het Clinical Trials Information System (CTIS) daadwerkelijk functioneel is.

De organisaties:

… agree that the CTIS portal suffers from serious deficiencies even after 10 months of practice and is largely unmanageable for all parties involved. These deficiencies have not been eliminated in the past months, but have increased. As a result, the submission of applications for clinical trials as well as their processing by the ethics committees is massively impaired and unmanageable. This will foreseeably lead to a considerable weakening of the competitiveness of Europe as a research region and to disadvantages and risks for patients. There is a real danger that the dysfunctionality of the CTIS portal will lead to a permanent migration of drug trials to other regions of the world. This would also have negative consequences for early access to new therapies for patients in Germany and the EU. In addition, the careful review of research applications by ethics committees is severely hampered by the dysfunctionality of the portal.

bron: AKEK ‘Massive Functional Problems of the EU Clinical Trials Portal CTIS Threaten Drug Research in Europe’ d.d. 28-11-2022

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