Better together – Collaboration in a Clinical Trial

What does a collaboration with Fraunhofer IIS actually look like during a clinical trial study? The following interview may give a clearer picture. We spoke to Sebastian Eckl, one of the founders of ProCarement GmbH, about his collaboration in a clinical trial with Fraunhofer IIS.  Sebastian, a former physician himself, co-founded ProCarement in 2019 alongside internist Tony Fuß. Motivated by the desire to prevent severely ill patients from leaving hospitals with a feeling of fear and overwhelm, they developed the first cardiological digital application, “ProHerz” for patients with heart failure. In order to obtain approval as a digital health application (DiGA) from the Federal Institute for Drugs and Medical Devices (BfArM), a study had to be conducted to demonstrate the intended effects. And that’s where Fraunhofer IIS comes into play.

dmac GmbH, a collaborative venture between Medical Valley and Fraunhofer IIS, is conducting the CARNA study for ProCarement. This partnership enabled a collaboration with Christian Weigand, head of the Mobile Health Lab group at Fraunhofer IIS, paving the way for the development of a customized system for CARNA and enabling precise data collection through the study management system DPM.research. (Find out more about dmac GmbH and the Mobile Health Lab here.)

Sebastian, how exactly did the collaboration with the institute take place?

Sebastian Eckl: Well, first we needed a preliminary study to see how everything would work. We couldn’t have done it manually — not with our manpower. That’s when dmac and Fraunhofer IIS gave us a helping hand.

They build us an individual platform consisting of a research database, consulting and external evaluation. Fraunhofer IIS then took care of the DPM.research part.

Fraunhofer IIS digitized the study protocol and put it together as several individual configured questionaries as an eCRF (electronic case report form). In the end, we conducted the first study with 70 patients and are now in the multicenter RCT (randomized clinical trial). Here we want to get to 500 patients, and there are already 200 of them. That would certainly not have been possible without Fraunhofer IIS and the DPM.research.

With the assistance of the study management system DPM.research, ProHerz has achieved preliminary listing as a digital health application by the Federal Institute for Drugs and Medical Devices (BfArM). The aim now is to achieve final listing. What actions are required to reach this goal, and will the cooperation also play a decisive role?

Yes, we definitely have to manage that. As I said, the study is ongoing. What we have now seen from the interim evaluation is that we already have three out of four primary endpoints in our pocket. Nevertheless, we would like to go through with the full RCT, even if this is no longer absolutely necessary for full and permanent listing. We believe that we can actually achieve that with the results so far and also with the case strength. The more data we collect, the higher the significance, of course.

So we can prove that we can achieve that goal not just with 12 patients, but 500. Such a number can only be managed via a digital platform.

Which advantage did the use of DPM.research have for you and the study?

We are a start-up; we couldn’t afford to hire people for that. So, the efficiency it provides is a huge advantage for us. Firstly, we don’t have the time constraints, and secondly, we don’t have the personnel burden. It’s also really great to have an external partner who also has credibility in the field of research. So, they reliably cover everything. It’s digitalized, which greatly improves things for the study centers and for us, allowing for quick evaluation. It benefits all parties involved.

Which conclusions can you draw about the use of the platform so far?

To put it simply, we will continue to use the platform, so we will continue to enjoy working with Fraunhofer IIS since it works great. And of course we want to improve our applications and make them even more user-friendly. We’re doing a lot of UX design, we’re increasing our staff in this area and we’ll also need a platform where we can collect these results and learn a lot from that.

ProCarement’s vision for the future is to create a virtual heart center for patients with all kinds of heart disease. This will also require a platform like DPM.research. That means that there is certainly no end in sight to the joint collaboration in a clinical trial.

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