29 November 2021

In the "White Paper Clinical Research", all national stakeholders jointly define an action plan to increase efficiency and quality.


The Swiss Academy of Medical Sciences recently published the "White Paper Clinical Research". This position paper was developed on behalf of the State Secretariat for Education, Research and Innovation and in collaboration with experts from various areas of clinical research. Mirjam Christ-Crain and Christiane Pauli-Magnus were involved in drawing up the White Paper.

Ms Christ-Crain, Ms Pauli-Magnus, what are the key messages of the White Paper Clinical Research?

M. Christ-Crain: The White Paper formulates seven goals in the sense of an action plan. Overall, the aim is to create an attractive environment for clinical research. This concerns, among other things, young researchers, for example, the possibility of taking time off from clinical work for research. But it also addresses the regulatory and administrative hurdles that are to be reduced. In addition, patients, the public and society should be better and more integrated into clinical research by giving them opportunities to participate. Methodological research should be promoted and ultimately a coordination platform should be created which is responsible for the implementation of all measures in Switzerland.

C. Pauli-Magnus: These individual messages in themselves are actually not new. There have already been a few of them in other places. What is indeed new is that for the first time we have succeeded in creating unity among all stakeholders for a joint statement and a commitment to Switzerland as a clinical research location. The stakeholders are the researchers and those who provide the infrastructure, but also patients and the public. They also include the Ethics Committee and the funding bodies, i.e. the State Secretariat and the Swiss National Science Foundation. A common starting point was formulated: What needs to change? Where should further investment be made? This is unique and has never been done before in this form.

Which institutions did you represent in this project and what perspectives does the White Paper open up from these institutions' point of view?

M. Christ-Crain: I have been delegated by the Swiss National Science Foundation to work on the implementation of the White Paper. From the perspective of the National Science Foundation, many of the things we have just mentioned are important. One of them is to develop structures that really do justice to clinical research. For example, on the subject of evaluation, it is a question of whether it would not be better to evaluate clinical research separately from basic research, i.e. with different criteria. Much more emphasis should be placed on clinical relevance, methodology and feasibility, and less focus should be placed on pure originality and innovation, because this is simply more difficult for clinical research in some cases. Another important point from the perspective of the National Science Foundation is the promotion of young researchers. MD-PhD programmes should be expanded. Overall, special funding is needed for clinical research in order to be able to release young researchers from clinical activities. Finally, Patient and Public Involvement (PPI) is a major concern.

C. Pauli-Magnus: I have been delegated by the Swiss Clinical Trial Organisation (SCTO), which I currently chair. This organisation represents the research infrastructures side, and it is a major concern of ours that the existing Swiss research infrastructures are better coordinated. This means that the many organisations, which all contribute valuable activities in their own right, should consider where there are overlaps or whether there are issues that could be tackled jointly. The stakeholders referred to here are, in addition to the SCTO, the Swiss Personalized Health Network (SPHN), the Swiss Academy of Clinical Cancer Research (SAKK) and the Swiss Biobanking Platform. There are a number of topics that can only be tackled together. A good example of this is the General Consent. Different institutions addressed this topic at the same time. Some of them rather with the perspective of the efficient use of data, others rather with the focus on patient and public involvement. I think that if there is a coordinated dialogue on such issues, you can move forward faster and more efficiently and have a stronger leverage effect at the political level.

White Paper: Clinical Research

2021

Author and publisher
Swiss Academy of Medical Sciences (SAMS)


Goals

  • What is the current state of clinical research in Switzerland?
  • How should it develop in the future?
  • What are the recommendations to achieve the future development goals?


Stakeholders
SNF, SCTO, SPHN, SBP, SAKK, SAMS, PHTR


Recommendations

  1. Creation of a national coordination platform
  2. Establishment of strong partnerships in the field of PPI
  3. Systematic integration of clinical research into the health care system
  4. Promotion of translational, multidisciplinary and integrated research teams
  5. Career development at all levels
  6. Reduce complexities - increase efficiencies


Publication
Download here



"What is new is that, for the first time, it has been possible to create unity among all stakeholders for a joint statement and a commitment to Switzerland as a clinical research location."

Prof. Christiane Pauli-Magnus, Co-Head of the Department of Clinical Research (DKF) and President of the Swiss Clinical Trial Organisation (SCTO)


The involvement of patients and members of the general public seems to be an important new topic. What is your view on this?

M. Christ-Crain: Involving patients and patient representatives in the assessment of research projects and asking them, for example, which endpoints of clinical studies are particularly relevant from their point of view will become increasingly important in the future. The assessment of relevance in particular is not always congruent from the point of view of patients and doctors. This year, for the first time, the National Science Foundation included patient representatives in the evaluation of applications in the so-called IICT call. That was a success and I think it will also be important in the future. However, I think that patient participation is not equally important in every study. In certain studies, such as those on breast cancer, the questions asked of patients are often relatively clear. There are also self-help groups and patient representatives who can be approached and included in surveys. It is much more difficult with other topics, such as electrolyte disorders or fatigue or other syndromes with unclear etiology, to name just a few examples. Therefore, I think it is an extremely important topic, and it is already established internationally in many countries, but you should not apply the same criteria to all studies, because otherwise that would also lead to yet another new regulatory hurdle.

C. Pauli-Magnus: I can only agree that PPI is a very important topic. Beyond the definition of patient-relevant endpoints, it is mainly about the aspect of creating trust. Specifically, it is about making sure, that patients who provide their routine data for research understand what is happening with it and that you alleviate their concerns about privacy. You have to address what data you are using and what you are using it for. That is one aspect. Another is that the Swiss National Science Foundation has now involved patient representatives in the evaluation for the first time. For the researchers, however, there were also difficulties. How do I make good and meaningful patient involvement? How does this fit into my study in the best way? You can see that some researchers simply lack the necessary instruments. This is a challenge for the infrastructures, including the SCTO. This brings us back to the fact that such topics should be tackled jointly. It does not make sense for the various organizations to address the topic of patient and public involvement all for themselves and to set up different committees and guidelines. It would be much better to consider how to bundle considerations in order to provide the best forum for researchers, Switzerland as a research location and ultimately, of course, for patients.



"We were convinced a long time ago that there had to be a vessel where the young people who want to do clinical research are well trained."

Prof. Mirjam Christ-Crain, Co-Head of the Department of Clinical Research (DKF) and Research Councillor at the Swiss National Science Foundation (SNSF)


Therefore, in the end it all comes down to the question of efficiency. However, the economic pressure on hospitals, universities and research in general is increasing. This potentially restricts the freedom of researchers. What suggestions does the White Paper offer to ensure that research remains attractive for future generations?

M. Christ-Crain: The compatibility of clinical activity and clinical research or research in general has always been a challenge. In order for research to remain attractive, we need precisely this freedom. In other words, time off from the clinic at all levels of the career. This starts with young physicians after graduation with an MD-PhD degree, where there should be more funding opportunities so that they can invest three to four years to be top trained for clinical research afterwards. These people end up being the ones who will do excellent clinical research in a few years. There is now a new initiative from the University of Basel and the University Hospital Basel. It allows mid-level faculty, doctors who do not have a structural professorship but do research, 20 to 30 percent time off if they have received a National Science Foundation grant. This is new and is being financed half by the university and half by the hospital. I think such initiatives are very important. There should be more of them because it makes research attractive and combine clinic with clinical research.

C. Pauli-Magnus: In the meantime, the opinion has gained ground that you can no longer do everything. You cannot be the top clinician and at the same time the top researcher, have the good ideas and implement them on your own from start to finish. At the same time, you need an environment, a research infrastructure that enables you to do excellent research. This is precisely what the National Science Foundation initiated 15 years ago with the establishment of Clinical Trial Units at all Swiss university hospitals. Here in Basel, the development continued when the CTU was integrated into the Department of Clinical Research eight years ago. I believe this is the way to go. If we now manage to integrate the other initiatives, then a clinical researcher really has the environment that makes it easier and enables him to implement great research ideas.

What initiatives are underway or have already been initiated to implement the recommendations from the White Paper?

C. Pauli-Magnus: I think quite a lot has already been taken up. It is not for nothing that we were both involved in this initiative and contributed our ideas. We have a few focal points. On the one hand, this is the promotion of young researchers, and on the other hand, we currently want to focus on creating an environment that optimally supports researchers in the area of patient and public involvement. We are not doing this alone, but quite deliberately together with the SCTO and the network of other stakeholders. Another topic that was initiated from Basel is methodological research. This accompanying research creates an evidence base for the investments we make here. Investments in both research methodology and infrastructure. So we ask ourselves: Which are the offers and what are their benefits? In which areas do we make progress and how? It has been acknowledged that this meta-research is important. A few years ago, that was not the case. We have researchers here in Basel at DKF whose research focus is in this area. They have not only contributed their ideas to the White Paper, but have also launched relevant initiatives at a national level.

M. Christ-Crain: I would like to add that we at the University of Basel were the first to develop an MD-PhD program for clinical research. We were convinced a long time ago that there had to be a place where young people who wanted to do clinical research, could receive good training. Now this program is very well established and is the fastest growing program in the medical school. This makes us a bit proud and I am pleased to see how many young people are motivated for research.

In summary, the White Paper Clinical Research is an important national initiative that has brought all stakeholders in academic clinical research to the table. In your estimation, the recommendations that emerged from this process all point in the right direction. Are there any criticisms that remain?

M. Christ-Crain: There is no criticism from my side. However, as far as the coordination platform is concerned, we are of the same opinion that the platform should not be yet another institution where money is poured in and new administrative posts are created. Rather, this platform should emerge from the already existing structures, so that administration is dismantled and not built up.

C. Pauli-Magnus: I can only support that. That was always our vote in this group. In any case, the Secretariat of State has taken up the idea that the various initiatives need to be better coordinated. How this should be done exactly is currently part of a follow-up project, which is again being led by the Swiss Academy of Medical Sciences. The organisations that have already worked on the White Paper will sit down together again to define how coordination should be organised in the future. In any case, we both agree that there is no need for yet another organisation across the various organisations, but ideally, a virtual coordination platform in which there is agreement on who has the lead on which topic and who needs to be integrated for input. For example, the Swiss Academy of Medical Sciences can then monitor developments and thus ensure that synergies are maximised.