Clinical Studies Sweden – a catalyst for clinical research
Interest in clinical studies and clinical medicine trials has increased sharply during the COVID-19 pandemic. The six nodes within the Clinical Studies Sweden have jointly received 12 million SEK from the Swedish Research Council to strengthen the preconditions for conducting clinical studies linked to COVID-19. For many researchers the challenges are many and the need for support and advice is great.
Clinical Studies Sweden is a collaboration between Sweden’s six healthcare regions via regional nodes, funded and supported by the Swedish Research Council. The collaboration, which began in 2015, aims to strengthen the preconditions for conducting clinical studies.
Finding solutions to joint national challenges is an important part of the collaboration.
Ann Tronde works as Regional Node Coordinator at Forum South, one of the six nodes. The node covers Sweden’s Southern Healthcare Region, which consists of Region Skåne, Region Kronoberg, Region Blekinge and the southern part of Region Halland.
– I am fervent about clinical research; it is an important part of the tasks set for health and medical care. The nodes have a solid and comprehensive bank of knowledge and experience, which contributes to simplifying and developing the conditions for conducting clinical studies in Sweden. The nodes cooperate closely, and our main task is to make it easier for researchers and other actors to plan and carry out clinical studies and trials.
One of several important tasks is to make it easier for the life science industry to access healthcare’s infrastructure for research and product development. Most regions have clinical trial units in close proximity to the node operation.
– Forum South’s clinical trial unit can carry out clinical medicine trials in all phases, non-intervention studies, and studies of medical devices on behalf of academia and life science companies. In this way, we are promoting medical research, innovation and product development for the benefit of patients.
Growing demand for support and training
There is great and growing demand for the services and training courses offered at the node, Ann Tronde tells us.
– We offer advice, project support, and training to researchers and research teams in all phases of clinical research projects. Researchers may need help with applications to public bodies, or advice about statistics and study design. They may also have questions about data management, or need help to create a research database. We can also support clinics in the practical implementation of studies, and with putting procedures in place. We also help with quality assurance and monitoring, to ensure studies are conducted with high quality and based on the regulatory frameworks that exist.
The node can also function as a sounding board for budget issues, and for thoughts about the level of compensation that is reasonable in relation to the work input required to conduct a study.
– We make budget calculations and can also support clinics in their negotiations with companies.
Training in GCP
A good example, Ann Tronde thinks, is Region Kronoberg, which has successfully developed a research plan in close collaboration with the political sphere. The aim is to ensure long-term improvement of the region’s resources and infrastructure for research. This involves things such as safeguarding research competence, increasing the number of clinical lecturer positions, and creating support structures to increase the number of internal and external research applications.
– An important part of the research plan is the investment in education aimed at operational managers, physicians, nurses and other professions involved in clinical research within the region.
A basic requirement for including patients in clinical studies is that the healthcare personnel has good knowledge of the ethical guidelines, regulatory frameworks and procedures that are part of the quality system known as Good Clinical Practice (GCP).
– Forum South offers and conducts GCP training courses. We have both foundation courses and advanced courses, and we also tailor courses based on operational needs. Our statisticians also contribute to third cycle courses in medical statistics and epidemiology at the Medical Faculty at Lund University.
Forum South collaborates closely with Regional Cancer Centre South, to give more patients receiving cancer care the opportunity to take part in clinical studies.
– We carried out a survey aimed at nurses, physicians and managers within cancer care, and followed up with a joint workshop. The purpose was to map the preconditions and obstacles in the way for conducting clinical studies within cancer care.
One of the factors that emerged was the important role played by operational managers in building and developing dynamic research culture.
– It is important to highlight and spread good examples that can encourage and inspire others to develop strategies for promoting clinical cancer research, says Ann Tronde.
Planning is also in progress for conducting GCP training courses for operational managers in the Southern Healthcare Region during the second quarter of 2021. The courses are funded by Regional Cancer Centre South.
It is a few months since Ann Tronde moved her workplace from Forum South, located at Skåne University Hospital in Lund, to her home.
On 20 March, everybody was notified that they should work from home due to the COVID-19 pandemic. There are some advantages of working from home, says Ann.
– I don’t have to commute, and have more time for my family. We live on the south coast of Skåne, and during my lunch break I can take a walk along the sea nearby. That is quality of life for me. But I miss my colleagues and the physical meetings. Meeting digitally doesn’t provide the same dimensions as real meetings. They are also more tiring.
During the ongoing COVID-19 pandemic, the nodes have had the important task of guiding and supporting researchers, clinics and pharmaceutical companies in their work of starting up clinical studies and trials. The six nodes within the Clinical Studies Sweden collaboration have jointly received 12 million SEK from the Swedish Research Council to strengthen the preconditions for conducting clinical studies linked to COVID-19.
– We have met with great interest. For example, we have supported intensive care units (ICU) in Region Skåne to develop a better infrastructure for collecting healthcare data. We have also been able to combine data from different databases to follow ICU patients over time, which has made it easier for doctors to draw conclusions about the effects of treatment.
– We are also seeing an increased number of study feasibility requests from industry relating to clinical medicine trials. Some of them relate to trials of existing medicines for a new indication, says Ann Tronde.
One example is a medicine to treat cystic fibrosis, which five seriously ill COVID-19 patients received ‘off-label’, that is to say the medicine was used outside the approved indication, as there is currently no approved treatment. The treatment was effective, and a study (NETS) is now being done of the medicine’s impact on COVID-19.
The study is being conducted at the infection clinic at Skåne University Hospital in Lund. The principal investigator and one of the initiators of the study, Adam Linder, Consultant Physician, contacted Forum South for support and advice. He had many questions relating to aspects such as study design, protocol writing, application procedures to public agencies, safety evaluation, and statistical analysis of data.
– We were able to help, so that he could get started on the study quickly. It is randomised, and covers 100 seriously ill COVID-19 patients. We are both proud and happy that we could be of help to such an important study, says Ann Tronde.
Background in life science
Ann Tronde trained as a biomedical chemist, and was awarded a PhD from Uppsala University for her thesis about medicine absorption across the lung barrier. She then worked for many years with research and development in the pharmaceutical industry.
– Straight after graduating, I worked with pharmaceutical research at a major company in Lund. I was then offered a doctoral studentship at the Faculty of Pharmacy at Uppsala University. After receiving my PhD, I worked with clinical research and development at Astra Zeneca for more than ten years, and got solid experience of working in global teams and leading large project groups. I also gained experience of managing clinical studies in collaboration with trial units and clinics in health and medical care, and in collaboration with CRO companies. My background is of great benefit in my current job as regional node coordinator, says Ann Tronde.
In her role, she is responsible for coordinating and developing the region’s support structures and services for clinical studies.
– We have a regional collaboration group, which includes our node managers and the heads of research from the four regions in the Southern Healthcare Region. The work consists of mapping needs to strengthen clinical research, and to get an overview of our joint services and training courses that we can offer to researchers and research personnel. The aim is to create synergies and more effective collaboration between regions.
The work has given rise to a regional collaboration model, based on defined goals and values.
– We have also invested time in building up relationships and creating trust within the node.
Developing a more equal model
Many of the issues discussed at regional level are also raised at national level, and vice versa. These may relate to both structural and strategic issues; for example, how can regions support and help each other with challenges relating to data management and disclosure of patient data for research? What does the new legislation on responsibility for good research practice and investigation of scientific misconduct, which came into effect on 1 January 2020, actually entail? How can small region attract and retain research-trained personnel through better terms and conditions?
– Our heads of research are working intensively on these issues, and on finding various types of solutions that make it possible to combine research with clinical work.
Fundamentally, it is about developing a more equal model, says Ann Tronde. Irrespective of where you are located geographically, the same equal opportunities shall exist for both researchers to start up clinical studies and for patients to take part in clinical trials.
– Our smaller regions are working hard to map out obstacles and create better preconditions for clinics at smaller hospitals to take part in clinical studies.
An entry point
The nodes are also working on coordinating their work on clinical studies regionally. At Forum South in Lund, Ann is working on strengthening collaboration between the four regions in the node, by gathering together questions, proposals, challenges and, in some cases, solutions.
Ann Tronde is also participating in the national work team for regional node coordinators. This offers opportunities to capture regional development needs, and share good examples, and also to disseminate results from the development initiatives being taken nationally.
– One of the initiatives concerns coordinated study feasibility requests. The purpose is to increase the number of study feasibility requests nationally, regionally and locally via the regional nodes.
One of the services offered is Country Feasibility Requests, a nationally coordinated service offered by Clinical Studies Sweden to academic researchers and life science companies.
– We want to offer an entry point, to Swedish health and medical care for study feasibility requests, rapid and national dissemination of the requests, and rapid feedback of assessments by experienced investigators. The service offers help to investigate whether a clinical study is feasible in Sweden based on national therapy guidelines, and to obtain overall views of the study design. It also provides an indication whether the investigators in question are interested in taking part in the study. The aim is to simplify and and make the process of study feasibility requests more efficient, for both companies and investigators.
The service can contribute to increasing Sweden’s competitiveness, and may be likened to the Danish system of ‘Trial Nation’, says Ann Tronde.
– Using this model, Denmark has succeeded in increasing the number of clinical trials. The hope is that Sweden will also succeed in strengthening clinical research by having more clinical studies located in Sweden.
Joint national website
Another important national initiative is the development of a new, joint website for Clinical Studies Sweden.
The research support that the nodes together offer will become clearer and more visible nationally, regionally and locally. In this way, the nodes can work together quickly to find the service or the support that a researcher is asking for. All nodes provide a basic service offering, but there are also more specialised services that cannot be offered by all nodes.
Via the website, the six regional nodes can offer a central route into unified national support for research.
– We are raising collaboration to a new level, and will be able to display our services and training courses much more clearly. It will also be easier for companies to send their study feasibility requests via a central entry point instead of having to contact the different nodes. We also foresee opportunities to match study feasibility requests with investigators/researchers who have notified an interest in conducting studies.
A more open working climate
Ann Tronde has worked for just over three years at Forum South. A lot of the work is about communication, establishing dialogues and ensuring different parties reach and understand each other. It is also about creating understanding about collaboration between different actors.
For many years, there has been a certain fear of close collaboration between healthcare, academia and industry. There are also differences in how academic research is regarded in comparison with industry-initiated research, and opportunities for gaining merit, Ann Tronde thinks.
– It is important that we collaborate on the documentation required for clinical studies, and that we safeguard the quality of new medicines. If we take part and contribute, we can be an important part of ensuring the documentation produced is of the highest quality.
– Personally, I feel that my work is incredibly stimulating. I have the chance to take part and make a difference. In the end, it is all about developing better healthcare and therapies for patients. And that does, of course, feels very meaningful.