On November 1, 2021, the new Local Feasibility Procedure and the use of the Research Institute Suitability Statement (VGO) will be in place. This is mandatory for drug research.
We spoke with Sanofi’s Thera Max-Mos, Head Clinical Study Unit ai, NL, to discuss these changes. We look at the impact this has had on the study and any teething problems in the procedure. She also shares her thoughts on the upcoming EU CTR introduction.
Thera, what will the introduction of the VGO change for you as the applicant of sponsor-initiated drug research in the Netherlands?
The moment a site is selected for participation in a study, we must provide them with a completed VGO. This means that we must already know what we need from the participating center for the research as a sponsor. So well prepared to start. We complete the VGO based on the final protocol, which is also submitted to the authorities (Health Authority of the reference member state) and the ethics committee. A lot is known already at the time of selection that has not yet been recorded in the final manuals. The VGO is structured in such a way that you can fill it in based on the final protocol.
Have you already done studies with a VGO? What is your experience, and what is the difference with the method we used for this?
We have now been able to apply the VGO a few times. On those occasions, the researchers were ready more quickly for the start of the study. It is efficient that how the study is presented to the participating research institutions is standardized.
An additional advantage is that the VGO in the hospitals is coordinated internally, which means less work for the sponsor.
Were there any “teething problems” that you had to deal with during these early studies, or any other issues you encountered?
The sponsor and research institution sometimes have a different understanding of the VGO. For example, the expectation of what information must be provided is not yet entirely the same. The local feasibility checklist helps with this. For example, what information must already be available about the budget when submitting the VGO to the participating center? And what budget information can follow later?
Clinical research is dynamic; there are often practical matters that only become clear after submission. With the VGO, we try to have as much clarity as possible before submission, but that is not possible for everything. Both parties must trust that this information backlog will be resolved after submission and before signing the contract.
Do you expect changes in the coming months?
Hopefully, confidence in the VGO process will increase, and everyone will experience that this harmonized method makes it easier to determine the suitability of a research institution for participation in a study.
Do you think the CROs and sponsors in the Netherlands will be ready when the EU CTR comes into effect on January 31, 2022?
Yes, I think so, but it is also an exciting moment for sponsors and CROs. Many details of the CTR and CTIS are only now being disclosed by the EMA, and all European countries should be ready. We are a bit concerned that not all hospitals in the Netherlands can go through the VGO process quickly enough. The VGO must be submitted at the initial submission. Failing that, we’ll lose these sites for our studies. We may not be able to add them again until the entire approval process in Europe has been completed five months later. That is unfortunate for the hospital and the Netherlands as a research country. Good cooperation between sponsors, CROs, and hospitals is now more critical than ever.
We want to thank Thera Max-Mos for sharing her insights into this vital change in clinical drug research.
Be well prepared with the Local Suitability Research Institution training
Preparing well for this procedure is a must if you do not want to lose time and continue participating in drug research.
That’s why the DCRF Academy, together with experts and eLearning developer GCP Central, has put together the best possible training to prepare you or your employees. The training “Local Suitability Research Institution (VGO)” is now available for you at GCP Central