Clinical trials are becoming more digital, patients more connected - what does this mean for clinical research? Viktor Grünwald, specialist in internal medicine, haematology and oncology at the Urological University Hospital in Essen, talks in an interview about the challenge of coordinating clinical trials, why the Corona pandemic is a missed opportunity for remote monitoring and why the automation of processes will continue to shape the research landscape.
Prof. Grünwald, the digital age is also shaping science and hospital operations. What challenges do clinical trials face today?
The coordination of clinical trials in particular is becoming increasingly complex. Digitalisation offers new possibilities for data collection, for example via the eCRF, the electronic case report form. But this places new demands on study teams. We often document twice - on paper and in the eCRF. This double data entry ties up a lot of time and my team's resources. Therefore, from the user side, I advocate deciding on a path and developing digital standards that apply to all studies. For example, it would help us to have a portal where you log in once and can maintain the data entry for different studies from there. The decisive factor here is functionality, which current developments still lack. The situation is similar with the feasibility questionnaires of the ethics committees; here, too, I would like to see a uniform standard that speeds up the completion and does not require repetitive, uniform entries. The definition and subsequent evaluation of the inclusion and exclusion criteria alone creates a lot of room for discussion and ties up an enormous amount of time for me and my team. Furthermore, I advocate for inspectors with medical expertise. The medical profession simply accepts different standard deviations and norms than those we know from industry. Patient care is needs-based and takes individual factors into account. We must be able to map this flexibility in protocols in order to provide excellent care.
To what extent has the Corona pandemic shown the limits of digitalisation?
The pandemic is a missed opportunity for remote monitoring, external digital data verification. Of course, some research institutes tried remote monitoring in the wake of the contact restrictions. But many also stopped studies in the first phase of the pandemic. The problem: there is a lack of uniform guidelines that would make it easier to introduce and establish. In fact, it makes no difference whether a clinical monitor views the data on site, i.e. on a computer in our clinic, or via digital access from anywhere in the world. If we use more secure encryption, no one has to worry about the data. If we were to rely more on remote monitoring, we could save resources, such as shortening the time it takes to travel - and thus achieve faster results.
Patients are becoming more and more the focus of attention. How must studies adapt to them?
Clinical trials put the patient in the centre, it's about the well-being of those affected. I would like to see more attention paid to the needs of patients. For example, there are studies in which they have to undergo a CT scan every six weeks - with no end in sight. I think these study designs miss the needs of patients. Close monitoring for six months followed by routine examinations every three months makes more sense to me. As soon as patients show stable values, the number of examinations should be reduced. In addition, we need to be more patient-centred in our education. We don't need a pamphlet that goes into every detail on more than 30 pages. Instead, we should make more use of the patient interview for education and focus on the essentials in the information.
What points would these be?
Patients must be clearly shown the treatment situation, they should understand what is in store for them in the coming months or even years. This also includes the effort they will have to put in. They should know what is expected of them, how much time they have to plan for visits, for example. In addition, they should be informed about the goal of the study: what results are expected, what is hoped for? Side effects also play a role. Here, however, doctors should not point out every smallest eventuality of undesirable effects, but rather go into more detail about relevant restrictions in everyday life. Many patients are well informed, they often know beforehand what they are getting into. The perception of studies has also changed. People now have more confidence in them and see participation as an opportunity rather than a burden.
What would it take on the part of the legislator to drive clinical research forward in Germany?
The different assessments of the German ethics committees in particular make Germany's role in international comparison difficult. The consultation procedure for studies differs from committee to committee and is difficult to calculate. Some sponsors therefore opt for other study centres abroad because the procedure there is less complicated. I would like to see uniform standards of review and hope that the EU's new approval procedure will bring about a change. For studies within Europe, one application will then be sufficient, and the authorities and ethics committees will decide on it together. There will no longer be a need for a separate review for each country. This will increase international competitiveness and at the same time simplify and speed up the procedures.
Studies are becoming more digital, people more connected. What demands will clinical research have to meet?
The process of data entry must be further simplified. In the digital age, all participants in clinical research need structures for automated data export. It still depends on the contract research organisation or the study centre how digitised a study is. We also need to keep queries to a minimum and better define which ones are really necessary. Currently, we are confronted with countless queries, the processing of which is not always goal-oriented. We should invest more time in health services research and generate everyday data. We could use this data for further studies in order to answer their questions in a shorter time. This would not only benefit study sites, but also patients.