Taking Clinical Trials to a new Level

In the following interview, we had the opportunity to speak to Christian Weigand and Stefan Bartosch about their software development designed for conducting digital, decentralized clinical trials.
Christian Weigand is head of the Mobile Health Lab group at Fraunhofer IIS. His team is dedicated to tackling every facet of medical data communication. Their mission encompasses the seamless transfer of patient information to healthcare providers. Furthermore, the main focus lies on data secure long-term storage as well as data collection and analysis in the context of studies. In its pursuit of innovation, the Mobile Health Lab collaborates closely with dmac, a collaborative venture between Medical Valley and Fraunhofer. This collaborative synergy has given rise to a software known as Digital Trial Manager. It revolutionizes the way studies are conducted by enabling digital and decentralized approaches. For more insights into this development, we had the opportunity to also speak with Stefan Bartosch, Managing Director of dmac.

Stefan, could you elaborate a little on dmac? What is your mission?

Stefan: dmac was established with a specific focus on assisting companies in the integration of their digital applications into the reimbursement processes of the German healthcare system. Navigating the reimbursement process in Germany can be quite challenging, especially considering recent legislative changes. Nonetheless, there are new opportunities emerging for manufacturers. For instance, since 2019, physicians have the authority to prescribe apps as part of medical treatment. At dmac, we provide guidance to healthcare solution manufacturers on matters related to reimbursement and market approval, accompanying them on the journey towards achieving the coveted “app on prescription” status. To facilitate this, we conceptualize study designs and help manufacturers generate evidence of both economic benefits and positive care outcomes. Our unique approach involves conducting the necessary clinical trials in a digital and decentralized manner, powered by our Digital Trials Manager (DTM). This innovative tool is based on a software solution developed in collaboration with Fraunhofer IIS. It has been tailored to meet the specific needs of dmac’s mission.

Christian, could you provide us with more details about the DTM software?

Christian: At Fraunhofer IIS, our primary focus is on delivering technical solutions to streamline the process of collecting data in clinical trials, particularly in the context of approving digital health applications. We’ve developed software that simplifies the conduction of these clinical trials. The DTM is our latest product offering, available as a service through dmac.

Our goal is to conduct studies exclusively in a purely digital and decentralized manner.

This marks a departure from the traditional center-based approach, where patients are required to visit a clinic multiple times for examinations and data collection. In contrast, with the DTM, we’ve introduced a fully digital process.

Stefan, what advantages do decentralized and digital study executions offer in comparison to traditional study methods?

Stefan: Decentralized and digital studies come with several distinct advantages when compared to traditional approaches. In traditional studies, participants often face the inconvenience of long journeys and significant efforts, which can lead to premature dropouts. On the flip side, digital and decentralized studies offer participants the convenience of engaging from their homes, even right from their couch. This doesn’t just boost participant retention but also brings significant savings in time and costs. With all processes fully digitized, there’s less time needed from study staff, physicians, and participants. Plus, it reduces dropouts, contributing to overall cost savings. Moreover, the digital and decentralized nature of these studies facilitates faster and more diverse participant recruitment, unrestricted by geographical limitations. In contrast,

approximately 80% of conventionally conducted clinical trials often face delays or even cancellation.

As a result, digital and decentralized studies not only provide enhanced convenience but also deliver remarkable efficiency gains in terms of both time and costs.

Could you walk us through the process of a study from a patient’s perspective? If I were interested in participating, how would I go about it?

Christian: To begin with, we employ various recruitment methods to inform patients about our studies. In today’s digital age, we often utilize social media platforms. Additionally, we collaborate with companies that have established patient databases. When a patient expresses interest, they receive an email or a link to our DTM software, which is essentially a website. There, they can complete the registration process, much like making an online purchase. Once the registration is finalized, the patient becomes part of our system. Following registration, there is a phase of patient education, usually conducted through a telephone or video conference with a study physician. During this session, the patient digitally signs off on the provided information. Depending on the study design, the patient is assigned to specific groups that will undergo various assessments. The patient is kept informed through our system with scheduled email notifications. These emails notify the patient about pending tasks. Subsequently, the patient logs into the DTM platform to check which tasks are awaiting their attention. These tasks can encompass various activities, including the completion of questionnaires or the measurement of essential data such as blood pressure, pulse, and weight. Assessing the software’s ease of use or usability may also be included in the tasks. As the study nears its conclusion, patients are informed that they’ve reached the final task, signaling that their participation in the study is drawing to a close. Once all participating patients have completed the study, a comprehensive study report is generated.

Stefan, one final question: which organizations or individuals should proactively reach out to your team? At what stage would this interaction be particularly beneficial?

Stefan: Our team is ideally positioned to assist both national and international manufacturers of patient-centric healthcare solutions who are eager to enter the German market. We extend our consulting services in various critical areas, encompassing reimbursement pathways (including DiGA, DiPA, selective contracts), interoperability, data security, privacy, regulatory compliance, and the provision of evidence. Furthermore, we stand ready to aid companies seeking support in conducting clinical trials.

We warmly welcome digital health enthusiasts who can benefit from our consulting and study services, as our collective aim is to collaborate and drive forward the digital transformation within the healthcare industry.

About us:

Elisa Bott has a background in business administration and has been working at dmac since 2019. She is specialized in marketing and project management. 

Image copyright: dmac