Interview with David Ruwe, Head Data Operations Medical and Monitoring
Editor:
Hello David. proderm Medical has submitted a study according to CTIS requirements for the first time - congratulations! Could you tell us what CTIS is, which products are affected by it and how it changes the submission process?
David:
Thank you very much. It was a real team effort, as CTIS was new territory for us as well. CTIS stands for the Clinical Trial Information System. The EU Regulation 536/2014, which came into force on 31.01.2022, standardizes the submission, assessment and monitoring procedures for clinical trials of medicinal products in Europe. CTIS is the central platform and working environment for the submission of information as well as the related communication between sponsors and the responsible ethics committee(s) and authorities. There is still a transitional period until 31.01.2023, during which clinical trials can alternatively still be submitted according to national procedures.
Editor:
Exciting. Why did you enter this new territory? You could have also submitted according to proven criteria?
David:
For us, the question was whether we should take the CTIS wave if we have to or if we want to. Basically, the submission process will be required via CTIS next January anyway. That's why we formed a competence team internally at an early stage, which dealt with all the requirements. And now that a project's structure was a good fit for the advantages of submitting via CTIS, we just went in at the deep end.
Advantages of the new procedure
Editor:
You mention the advantages of submitting via CTIS. What are they in your opinion?
David:
First of all, the harmonization of the submission process for the whole of Europe, which improves comparability. Secondly, the common workspace for clinical trial SPONSORS, the ethics committees and the authorities, as well as the associated transparency of the evaluation steps. CTIS offers a significant advantage for the submission of multicentre and multinational studies. Required documents are uploaded once centrally and distributed through the system. This is much more time-consuming via the "old" way, as each ethics committee has to be contacted separately and provided with the relevant documents.
Editor:
The CTIS procedure has particular advantages in the context of multinational and multicentre studies. However, from 31.1.2023 at the latest, monocentric studies must also be submitted via the CTIS platform. Can I assume that the current submission is based on a multicentre project and can your experience be transferred to monocentric studies, or will the cards be reshuffled there?
David:
Yes, that's right, the current submission goes back to a multicentre project. As I said, it was just a good fit. However, I am convinced that the advantages of the central information platform and transparent evaluation will also come into play in monocentric studies and that our current learnings will make many things easier for us in the next submission process. In terms of sustainability, I also welcome the fact that the process is becoming more digital and thus the large amount of paperwork is being significantly reduced.
The role of the SPONSOR
Editor:
As a full-service provider, we take on the tasks associated with the submission. What is the role of the SPONSOR in this?
David:
Without the sponsor, the process does not work. As a first step, he has to assign us a specific role in CTIS so that we are allowed to carry out the submission on his behalf. In addition, the SPONSORS still have a very central role as they have to provide a lot of necessary quality and safety documentation related to their drug. We have now developed many skills in dealing with CTIS, close cooperation between proderm and the SPONSORS remains the be-all and end-all of a successful submission.
Editor:
Is it correct that CTIS also offers an area where studies submitted via CTIS can be viewed by the public and how do you assess the current usage based on the information available there?
David:
CTIS is basically nothing more than a website that can be accessed via the URL euclinicaltrials.eu. And yes, there is a public area there with information about the registered studies. Taking into account the system availability since January this year and the currently still quite small number of registered studies, I judge the use as 'cautiously restrained'. I can well imagine that this is due to the scope of the system. We also felt somewhat overwhelmed at the beginning. I am all the happier that we have successfully overcome this hurdle and can continue to offer our clients a service in line with the latest requirements.
Editor:
Thank you very much for the interview.
