Pharma

What does the future of clinical research look like? Three experts provide an outlook

Digitalisation is changing study procedures and diagnostic possibilities, while new innovations are shaping clinical research. How will the study landscape develop in the coming years, and what challenges will research and companies face?

Prof Vogel Claussen

(Photo: Stefan Knaak Photography)

Prof. Dr. med. Jens Vogel-Claussen, radiologist and investigator at the Hannover Medical School


What will clinical research look like in ten years?

As a radiologist, I am convinced that imaging biomarkers will increasingly establish themselves in studies and diagnostics. The diagnosis will be supported by AI, whose algorithms recognise changes and patterns that medical professionals cannot detect with the naked eye. Fully automated, these imaging biomarkers will complement the image data and thus lead to a greater and more accurate variety of data.

What requirements arise from digital developments?

Studies will become increasingly networked in the future. But for this, we need the right infrastructure: secure clouds and IT that ensure not only optimal data processing but, most importantly, data protection. CROs like Alcedis, who provide this infrastructure and are responsible for data management, data quality and data security, must fulfil their tasks perfectly and will become increasingly important in the future. Their knowledge and planning is key for future studies to be efficient and secure.

What challenges will future studies face?

The awareness of data security – which, as lead investigator, I’m responsible for – has increased enormously. I think it is right that participants have to answer whether they want to share their information every time they click on the digital questionnaire. In future, this question will be included into every eCRF.

Digital progress is developing rapidly. I welcome this development, because in the digital world we not only collect more data, the documentation is also more complete. This moves our studies forward - and all partners involved have to keep pace. Those who do not keep up to the technical demands of our time will eventually no longer get any projects.

 

Julia Hoxha

(Photo: Tobias Koch)

Julia Hoxha, CEO and co-founder of Zana

What will clinical research look like in ten years?

I see two main pillars of innovation for the future. One of them is the decentralisation of clinical trials. Last year, the Corona pandemic showed that clinical research must also function independently of a location. I believe that data and information can be increasingly collected from home (in situ) or on the go with the help of digital solutions. But for this to happen, processes need to be optimised.

This brings me to the second point: the application and further development of artificial intelligence. AI will play an increasingly important role in the future. With the help of AI, patients can be recruited for clinical trials, research projects can be monitored remotely, data can be analysed and adherence can be monitored.

What requirements arise from digital developments?

We need uniform framework conditions and regulations for data protection and ethical guidelines. This concerns not only the quality control of data, but also the interaction with patients themselves.

What challenges will future studies face?

Ethical guidelines and data protection are an important issue for us as a company. These rules determine how we can use the decentralisation and development of AI. A challenge here is also how to deal with the new data. When we gain new information from a real-world setting, we have to think carefully about how we can use it for new clinical projects and therapeutic approaches. We must not stop at mere data collection and analysis. For the sake of patients, we should use this for the development of new drugs and therapies.

 

Dr. Jessica Hassel

Prof. Dr. med. Jessica Hassel, Section Head for Dermatological Oncology at the University Dermatology Clinic at the National Centre for Tumour Diseases in Heidelberg

What will clinical research look like in ten years?

The research landscape has changed massively in the past 15 years. The number of studies has increased dramatically, while regulations have become stricter and documentation has become more elaborate. I expect clinical research to become increasingly complex in the coming years, be it the registration with ethics committees or the increased demand on specialised staff such as study nurses who supervise contracts between sponsors and trial centres.

At the same time, the well-being of the patients must not be forgotten. The more regulations there are, the more difficult it becomes to test new therapies in a timely manner with the help of studies I hope that in the future, studies will become part of routine treatments for clinics like ours and not fail due to bureaucratic regulations in order to offer patients better chances.

What requirements arise from digital developments?

We benefit greatly in clinical trials from the eCRF, the digital case report form. But new requirements arise from this development, and digitalisation should be expanded to other processes. Currently, many documents in our studies are still printed out and signed by hand, even though this would also be possible electronically. Furthermore, in many cases we maintain double documentation: first we write everything down on paper and then transfer it to the electronic system. I would like to see more investment in digitalisation in clinical research. That would simplify our workflows and tie up less time, which would benefit the conduct of our studies.

Digitalisation also offers us the opportunity to network more closely with other national or international studies, to collect data together. Here I would like to see more flexibility from the authorities. Some time ago, we wanted to participate in a study in the Netherlands, which was already very successful and met European standards. However, the German authorities demanded changes in the study protocol that would have greatly altered the study for the German patients, jeopardising the equality of the study patients. Even though the regulations have changed since the study was submitted in the Netherlands, it should still be possible to treat an already ongoing and approved study in Germany. For this reason, the cooperation fell through, which was particularly unfortunate for our patients, because it would have been an excellent treatment option with already very good scientific data.

I think authorities should be more open here and assume that doctors in other European countries approach therapy and research with the same approach: The patient and their health are the focus. European guidelines might help here.

What challenges will future studies face?

In our daily clinic routine, I often notice how difficult it is to set up a good study team. My study nurses have been with me for ten years, and I am very happy about that. Finding new staff is almost impossible because the number of studies and the demand for well-trained professionals is increasing.

Funding also poses great challenges for clinical trials. I am currently planning an IIT (Investigator Initiated Trial), which compares drug therapies. It has no commercial interest, but solely serves clinical research. It is very difficult to get funding for such studies because pharmaceutical interest is assumed in research applications and funding is therefore rejected. Conversely, pharmaceutical companies shy away from IITs if the university hospitals take 40 percent overhead. These are questions that arise from the doctor and with which he or she appeals for support from the pharmaceutical company.

I ask myself how we are to guarantee the infrastructure of a study in the future. In addition, we are dependent on the willingness of the patients. Many decide to participate in a study because they have had positive experiences in the past or hope for progress in addition to the standard therapy. But there are also patients who are extremely critical of us because of reports in the media or social networks. It is important to convince them to reduce their mistrust - because studies make therapies possible that are otherwise not available to patients, and the only thing we doctors and researchers care about is their health.

 

Text: Alcedis-Redaktion